Clinical trial NCT03684811
Conditions: Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme) Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Cohort 3a and 3b: Chondrosarcoma Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
Keywords: Olutasidenib
Sponsor: Forma Therapeutics, Inc.
Start date: 2018-11-01; Completion date: 2022-06-13
Enrollment: 93 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.

The study is divided into two parts: single agent FT-2102 followed by combination therapy.

Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored.

Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: FT-2102 intervention 2: Azacitidine intervention 3: Nivolumab intervention 4: Gemcitabine and Cisplatin
Intervention descriptions: intervention 1: FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level. intervention 2: Azacitidine will be administered per the site's standard of care. intervention 3: Nivolumab will be administered per the site's standard of care. intervention 4: Gemcitabine and cisplatin will be administered per the site's standard of care.

Protocol documents:
Prot_000.pdf: 
Protocol 2102-ONC-102 
FORMA Therapeutics, Inc. 
FT-2102  
(Version 5) 28 January 2020 
    CONFIDENTIAL 
Page 1 of 113 
STUDY PROTOCOL 
2102-ONC-102 
Protocol Title: 
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors 
and Gliomas with an IDH1 Mutation 
Protocol Number: 
2102-ONC-102 
Phase: 
1b/2 
Date of Protocol: 
28 January 2020  
Version: 
Version 5 (Amendment 4) 
US IND number:  
EudraCT:   
NCT:
139611 
2018-001796-21
NCT03684811 
Sponsor: 
FORMA Therapeutics, Inc. 
500 Arsenal Street, Suite 100 
Watertown, MA 02472 
Not for Distribution – Do Not Copy 
This study protocol contains confidential information and is the proprietary property of 
FORMA Therapeutics, Inc. The protocol is for use by the Principal Investigator and his/her designated 
representatives participating in this investigational trial. This protocol may not be copied or made available 
for review by an unauthorized person or firm without the prior written authorization of FORMA 
Therapeutics, Inc. 


Protocol 2102-ONC-102 
 
FORMA Therapeutics, Inc. 
FT-2102  
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    CONFIDENTIAL 
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INVESTIGATOR PROTOCOL APPROVAL 
 
I agree to the terms of this study protocol. I will conduct the study according to the procedures 
specified herein, and according to principles of Good Clinical Practice and local regulations and 
requirements. 
 
Institution/Clinic:  ___________________________________________ 
 
Principal Investigator 
 
Print Name:  ______________________________________ 
 
Signature:  
______________________________________ 
 
Date (dd/mmm/yyyy): ______________________________ 
 
 






Protocol 2102-ONC-102 
 
FORMA Therapeutics, Inc. 
FT-2102  
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    CONFIDENTIAL 
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PROTOCOL SYNOPSIS 
Study Title: 
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 
Mutation  
Protocol Number: 
2102-ONC-102 
Phase: 
1b/2 
Study Drugs: 
Cohort 1: Glioma 
• 
FT-2102 (FT-2102) single-agent or in combination with 5-azacitidine   
Cohort 2: Hepatobiliary Cancers  
• 
FT-2102 single-agent or in combination with a programmed death-1 (PD-1) inhibitor: 
nivolumab 
Cohort 3: Chondrosarcoma 
• 
FT-2102 single-agent or in combination with 5-azacitidine  
Cohort 4: Intrahepatic Cholangiocarcinoma (IHCC) 
• 
FT-2102 single-agent or in combination with gemcitabine and cisplatin chemotherapy 
(GemCis) 
Cohort 5: Other Solid Tumors (non-central nervous system [CNS]) with Isocitrate Dehydrogenase 1 
(IDH1) Mutations 
• 
FT-2102 single-agent 
Study Population: 
This study will enroll up to approximately 200 patients across 4 disease-specific cohorts and 1 
exploratory cohort in non-CNS solid tumors. 
The study will include a Safety Lead-in Period, which will enroll approximately 6 patients with 
histologically or cytologically-confirmed IDH1 R132X gene-mutated advanced solid tumors and 
approximately 6 patients with histologically or cytologically-confirmed IDH1 R132X gene-mutated 
advanced gliomas that have recurred or progressed following standard therapy. Additional patients may 
be enrolled if different doses or an altered dosing schedule are explored. Patients enrolled during the 
Safety Lead-in Period who meet the criteria for enrollment into 1 of the 4 disease-specific cohorts 
outlined below will be counted as part of the Stage 1 evaluation for those disease-specific cohorts at the 
same dose.  


Protocol 2102-ONC-102 
 
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Study Title: 
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 
Mutation  
Cohort 1 will include 16-46 evaluable patients with relapsed or refractory glioma (per World Health 
organization [WHO] criteria 2016) with confirmed IDH1 mutation.  
Cohort 2 will include approximately 21-78 evaluable patients with relapsed or refractory hepatobiliary 
tumors with confirmed IDH1 mutation previously treated with an approved therapy for hepatobiliary 
cancer (HBC). 
Cohort 3 will include approximately 16-46 evaluable patients with recurrent, refractory or either locally 
advanced or metastatic chondrosarcoma with confirmed IDH1 mutation not amenable to complete 
surgical excision. 
Cohort 4 will include approximately 21-77 evaluable patients with advanced, nonresectable or 
metastatic intrahepatic cholangiocarcinoma with confirmed IDH1 mutation not eligible for curative 
resection or transplantation. 
Cohort 5 will include up to 6 patients with relapsed or refractory other tumors with confirmed IDH1 
mutation. 
Study Duration: 
It is estimated that this study will last approximately 30 months. The expected duration of study 
treatment for each patient will be approximately 26 weeks.  
Patients will remain on study treatment (either single-agent FT-2102 or combination therapy) until 
disease progression or unacceptable toxicity. 
Patients will be followed for safety for 28 days after last dose of study drug or until resolution or 
stabilization of ongoing adverse events (AEs).  
Patients may be followed for survival approximately every 3 months for up to 24 months from first 
dose of study treatment or for up to 12 months after treatment discontinuation (whichever is longer). 
The end of the study will be defined as last patient last visit (LPLV). 
Study Centers: 
Enrollment is anticipated at approximately 50 global sites (in North America, Europe, and Asia 
Pacific). 
 
 


Protocol 2102-ONC-102 
 
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Study Design: 
This is a multicenter, Phase 1b/2, open-label, multiple-cohort study examining the efficacy and safety 
of FT-2102 as a single agent or in combination for the treatment of patients with advanced solid 
tumors and gliomas with an IDH1 R132X mutation.  
The starting dose of FT-2102 is 150 mg twice daily (BID) administered continuously in 28-day 
cycles; the selection of the starting dose is based on results from a Phase 1 study in patients with 
hematologic malignancies.  
Safety Lead-in Period: Phase 1b 
Safety Lead-In, Single-Agent: The study will consist of a Safety Lead-in Period to confirm the safety 
and tolerability of single-agent FT-2102 150 mg BID administered over 28 days (1 cycle). The Safety 
Lead-in Period will employ a traditional 3+3 design, whereby 3 patients with any of the specified 
solid tumors and (Cohorts 2a-5a) or glioma (Cohort 1a) are treated with FT-2102 150 mg BID and 
monitored for dose-limiting toxicities (DLTs) during the first cycle of study treatment.  
• 
If no dose-limiting toxicities occur in the first 3 patients in either the solid tumor group (Cohorts 
2a-5a inclusive) or the glioma group (Cohort 1a), and available pharmacokinetic 
(PK)/pharmacodynamic (PD) data support the dose, enrollment will continue in the 4 disease-
specific cohorts described below.  
• 
If a DLT occurs in the first 3 patients in either group, an additional 3 patients will be treated at 
that dose level in either the solid tumor group (Cohorts 2a-5a inclusive) or the glioma group 
(Cohort 1a). If no DLTs occur in these additional 3 patients (ie, <2 DLTs per 6 patients) and 
available PK/PD data support the dose, enrollment will continue in the 4 disease-specific cohorts 
described below.  
• 
If there are ≥2 DLTs at the starting dose, 150 mg once daily of FT-2102 will be evaluated 
following review by the Safety Review Committee (SRC). Likewise, higher doses may be 
evaluated based upon safety, PK, and PD data as determined by the SRC.    
Safety Lead-In Combination: DLTs will be evaluated within the first 3 (or 6) patients of any cohort 
examining combination therapy to confirm the safety and tolerability of combination therapy 
administered over 28 days (1 cycle) for Cohort 1b, Cohort 2b, Cohort 3b, and Cohort 4b using a 3+3 
design (i.e., up to the first 6 patients in each combination cohort).  The cohort will be stopped if there 
is more than 1 DLT out of the first 6 patients, and additional dose levels will be evaluated as follows:  
• 
If no DLTs occur in the first 3 patients in a combination cohort and available PK/PD data 
support the dose, enrollment will continue in  that disease-specific cohort.  
• 
If a DLT occurs in the first 3 patients in a combination cohort, an additional 3 patients will be 
treated at that dose level. If no DLTs occur in these additional 3 patients (ie, <2 DLTs per 
6 patients) and available PK/PD data support the dose, enrollment will continue in the specific 
combination cohort.  
• 
If there are ≥2 DLTs at the starting dose, the following dose de-escalations of either the 
combination agent or FT-2102 will be evaluated following review by the SRC. Following that 
evaluation, the SRC will evaluate the available safety, PK, and PD data to determine the dose(s) 
to be used in the combination Phase 2.  


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FT-2102 + Azacitidine  
Dose Level 
FT-2102 
Azacitidine 
-1 (Hematologic DLT) 
150 mg BID  
continuously × 28 days 
37 mg/m2/day intravenous (IV) × 7 
days every 28 days 
-1 (Non-Hematologic DLT) 
150 mg QD  
continuously × 28 days 
75 mg/m2/day IV × 7 days every 
28 days 
1 (Starting Dose) 
150 mg BID  
continuously × 28 days 
75 mg/m2/day IV × 7 days every 
28 days 
FT-2102 + Gemcitabine/Cisplatin 
Dose Level 
FT-2102 
Gemcitabine/Cisplatin 
-1 (Any DLT) 
150 mg once daily 
continuously × 28 days 
Cisplatin 25 mg/m2 IV followed by 
gemcitabine 1000 mg/m2 on Day 1 
and Day 8  
1 (Starting Dose) 
150 mg BID continuously × 
28 days 
Cisplatin 25 mg/m2 IV followed by 
gemcitabine 1000 mg/m2 on Day 1 
and Day 8 
FT-2102 + Nivolumab 
Dose Level 
FT-2102 
Nivolumab 
-1 (Any DLT) 
150 mg once daily 
continuously × 28 days 
240 mg IV every 2 weeks 
1 (Starting Dose) 
150 mg BID continuously × 
28 days 
240 mg IV every 2 weeks 
Other Non-CNS Solid Tumors with IDH1 Mutations (n=6, Cohort 5a) 
Up to 6 patients with relapsed or refractory non-CNS solid tumors harboring an IDH1 R132X 
mutation. This cohort will only include treatment with single-agent FT-2102. Due to the diverse 
population, this is an exploratory cohort without pre-defined efficacy/futility determinations. 
Aggregate safety data will be monitored by the SRC and if unacceptable toxicity (a DLT) is observed 
in ≥2 of the first 6 patients, the cohort will be closed for additional enrollment. 


Protocol 2102-ONC-102 
 
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Disease-Specific Cohorts: Phase 2 
Four disease-specific cohorts will employ a stage-wise design, whereby 8 patients in the first stage of 
each cohort will be treated with study therapy (either single-agent FT-2102 or in combination with 
antineoplastic agents) and evaluated for efficacy and safety.  
After up to 8 patients in Stage 1 have been evaluated for at least 4 cycles of study treatment, disease-
specific efficacy data will be evaluated to determine continued enrollment to Stage 2. Enrollment will 
continue during the Stage 1 evaluation. If Stage 1 efficacy criteria from any single-agent FT-2102 
cohort is not met, then examination of combination therapy may be initiated in a new Simon’s 2-
stage design.  
Safety data from Stage 1 will also be reviewed on an ongoing basis by SRC. Significant safety 
findings may lead to an early stopping for any cohort and will be considered when deciding to initiate 
Stage 2 of any cohort.  
For the Safety Lead-in Period and Stage 1 of each disease-specific cohort, blood samples for PK and 
PD will be obtained. Limited PK and PD samples will be obtained during Stage 2.  
Overall response is defined as follows: 
- 
Glioma: the proportion of patients with a best response of complete response/remission (CR) 
or partial response/remission (PR) or minor response (MR) (low-grade glioma [LGG]) 
- 
Hepatobiliary cancer: the proportion of patients with a best response of CR or PR 
- 
Chondrosarcoma: the proportion of patients with a best response of CR or PR 
- 
Intrahepatic Cholangiocarcinoma: the proportion of patients with a best response of CR or 
PR 
Cohort 1: Glioma (n=16-46) 
Cohort 1 will include patients with glioma harboring an IDH1 R132X mutation that is relapsed or 
refractory. Glioma patients will be initially treated with single-agent FT-2102 (Cohort 1a). Cohort 1a 
will employ a Simon’s 2-stage design, in which 8 evaluable patients will be treated with single-agent 
FT-2102 for a minimum of 4 cycles (cycle=28 days) and assessed for efficacy and safety (Stage 1). If 
≥1 clinical response is observed in Stage 1, then Stage 2 (n=15) will initiate with single-agent FT-
2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination therapy 
may be examined (FT-2102 + 5-azacitidine) (Cohort 1b). Cohort 1b will employ the same Simon’s 
2-stage design, enrolling 8 evaluable patients in Stage 1 and 15 evaluable patients in Stage 2 with 
combination therapy.  
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: Any glioma patients enrolled in the Safety Lead-in Period will be considered part of Stage 1 
enrollment for single-agent or combination treatment.   
Cohort 2: Hepatobiliary Cancer (HBC) (n=21-78) 
Cohort 2 will include patients with relapsed/refractory HBC harboring an R132X IDH1 mutation. 
HBC patients will be initially treated with single-agent FT-2102 (Cohort 2a). Cohort 2a will employ 


Protocol 2102-ONC-102 
 
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    CONFIDENTIAL 
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a Simon’s 2-stage design, in which 8 evaluable patients will be treated with single-agent FT-2102 for 
a minimum of 4 cycles (cycle=28 days) and assessed for efficacy and safety (Stage 1). If ≥1 clinical 
response is observed in Stage 1, then Stage 2 (n=15) will receive single-agent FT-2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination therapy 
may be examined (FT-2102 + PD-1 inhibitor) (Cohort 2b). Cohort 2b will employ a new Simon’s 2-
stage design, whereby 13 evaluable patients will be treated in Stage 1 with combination therapy for a 
minimum of 4 cycles (cycle=28 days) and assessed for efficacy and safety. If ≥4 clinical response is 
observed in Stage 1 of Cohort 2b, then Stage 2 (n=42) will initiate with combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any HBC patients enrolled in the Safety Lead-in Period will be considered part of Stage 1 
enrollment. 
Cohort 3: Chondrosarcoma (n=16-46) 
Cohort 3 will include patients with relapsed/refractory, locally advanced or metastatic 
chondrosarcoma harboring an R132X IDH1 mutation. Chondrosarcoma patients will be initially 
treated with single-agent FT-2102 (Cohort 3a). Cohort 3a will employ a Simon’s 2-stage design, in 
which 8 evaluable patients will be treated with single-agent FT-2102 for a minimum of 4 cycles 
(cycle=28 days) and assessed for efficacy and safety (Stage 1). If ≥1 clinical response is observed in 
Stage 1, then Stage 2 (n=15) will initiate with single-agent FT-2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination therapy 
may be examined (FT-2102 + 5-azacitidine) (Cohort 3b). Cohort 3b will employ the same Simon’s 
2-stage design, enrolling 8 evaluable patients in Stage 1 and 15 evaluable patients in Stage 2 (n=15) 
with combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any chondrosarcoma patients enrolled in the Safety Lead-in Period will be considered part of 
Stage 1 enrollment. 
Cohort 4: IHCC (n=21-77) 
Cohort 4 will include patients with advanced IHCC harboring an R132X IDH1 mutation. IHCC 
patients will be initially treated with single-agent FT-2102 (Cohort 4a). Cohort 4a will employ a 
Simon’s 2-stage design, in which 8 evaluable patients will be treated with single-agent FT-2102 for a 
minimum of 4 cycles and assessed for efficacy and safety (Stage 1). If ≥2 clinical responses  are 
observed in Stage 1, then Stage 2 (n=14) will initiate with single-agent FT-2102.   
If <2 clinical responses are observed in Stage 1 with single-agent FT-2102, then combination therapy 
may be examined (FT-2102 + GemCis) (Cohort 4b).  
Cohort 4b will employ a Simon’s 2-stage design, whereby 13 evaluable patients will be treated in 
Stage 1 with combination therapy for 4 cycles and assessed for efficacy and safety.  
If ≥4 clinical responses are observed in Stage 1 of Cohort 4b, then Stage 2 (n=42) will be initiated 
with combination therapy. 


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During Stage 1, aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any IHCC patients enrolled in the Safety Lead-in Period will be considered part of Stage 1 
enrollment.  
Combination therapy in cohorts 1-4 may also be examined in the event that the single agent cohort 
passes the futility analysis and the enrollment in the single agent cohort is completed following 
review by the SRC (below).  
Safety Review Committee 
This study will utilize an SRC, which will meet quarterly at a minimum to review all accumulated 
data, including safety, PK, PD, and efficacy. The SRC will be composed of a medical representative 
from the Sponsor, and all Principal Investigators (PIs) or delegates at each of the enrolling sites. The 
SRC will use all available data to confirm dose decisions and if needed recommend changes to the 
dosing paradigm. 
Dosing Frequency 
FT-2102 will initially be administered either as a single agent at 150 mg BID or in combination until 
disease progression or unacceptable toxicity. In the combination cohorts, FT-2102 150 mg BID will 
be administered in combination with 5-azacitidine in glioma and chondrosarcoma, with nivolumab in 
HBC, and with GemCis in IHCC. The SRC will monitor the safety, PK, and PD of both single-agent 
FT-2102 and combination therapy during Stage 1 of each cohort and may recommend altering the 
dosing paradigm based on available data. The SRC will conduct an aggregate assessment of PK/PD 
data as well as a review of the study drug-related AEs to ensure that the combination therapies is safe 
and well tolerated. 
Monitoring of Adverse Events: 
Patients will be monitored continuously for toxicity while on study drug. AE severity will be 
assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI 
CTCAE) version 4.03. If a patient has an AE of a particular severity or an AE assessed as at least 
possibly related to study drug, then dose modifications will be made according to the guidelines set 
forth in the study protocol. 
DLT Evaluation Period/Definition: 
Single-Agent Safety Lead-in  
DLTs will be evaluated during the Safety Lead-in Period during the first treatment cycle (28 days) 
using NCI CTCAE criteria version 4.03 and defined for each part of the study as described below. 
Drug relatedness will be Investigator -assessed. Grade 3 laboratory abnormalities recorded as an AE, 
but without clinical sequelae and not requiring treatment, are not considered DLTs. Disease 
progression is not considered an AE if assessed by Investigator  to be unrelated to study agent. 
Any DLTs that occur after the Cycle 1 DLT review period will still be considered by the SRC in the 
evaluation of Stage 1 from the Simon’s 2-stage design and for the overall recommended phase 2 dose 
(RP2D). 
DLTs include the following AEs unrelated to underlying disease and considered related to FT-2102: 


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• 
Non-hematologic 
• 
≥Grade 3 toxicity except: Grade 3 nausea, vomiting, diarrhea, or rash: lasting <72 
hours (with optimal medical management)  
• 
Clinically relevant (i.e. requiring treatment or with clinical sequelae)  
≥Grade 3 non-hematologic laboratory finding  
• 
Hematologic  
• 
≥Grade 3 thrombocytopenia 
• 
Grade 4 neutropenia lasting for >7 days 
• 
≥Grade 3 febrile neutropenia 
Combination Therapy Safety Lead-in  
DLTs will also be evaluated during Stage 1 of any cohort examining combination therapy (Cohort 
1b, Cohort 2b, Cohort 3b, and Cohort 4b) using a 3+3 design. DLTs will be assessed during the first 
full treatment cycle of both agents (28 days) using NCI CTCAE criteria version 4.03. Drug 
relatedness will be Investigator -assessed. Grade 3 laboratory abnormalities recorded as an AE, but 
without clinical sequelae and not requiring treatment, are not considered DLTs. Disease progression 
is not considered an AE if assessed by the Investigator  to be within the expected tempo of that 
disease. 
Any DLTs that occur after the Cycle 1 review period will still be considered by the SRC in the 
evaluation of Stage 1 from the Simon’s 2-stage design and for the overall recommended phase 2 dose 
(RP2D). 
DLTs include the following AEs unrelated to underlying disease, considered related to FT-2102, and 
unrelated to the known toxicities of the combination agent(s): 
• 
Non-hematologic 
• 
≥Grade 3 toxicity except Grade 3 nausea, vomiting, diarrhea or rash: lasting <72 
hours (with optimal medical management) 
• 
Clinically relevant (i.e. requiring treatment or with clinical sequelae)  
≥Grade 3 non-hematologic laboratory finding  
• 
Hematologic  
• 
Grade 4 thrombocytopenia 
• 
Grade 3 thrombocytopenia with grade 2 or greater bleeding  
• 
Grade 4 neutropenia lasting for >7 days 
• 
Grade 4 febrile neutropenia 
Study Objectives: 
Primary Objective (Phase 1b) 
• 
Evaluate the safety and tolerability of FT-2102 as monotherapy and confirm the dose to 
be further examined in expansion cohorts as monotherapy and combination therapy  


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Secondary Objective (Phase 1b):  
• 
Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-cancer 
agents  
• 
Evaluate the clinical activity of FT-2102 as a single-agent or in combination in patients 
with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation 
Primary Objective (Phase 2) 
• 
Evaluate the clinical activity of FT-2102 as monotherapy or in combination in patients 
with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation 
Secondary Objective (Phase 2) 
• 
Evaluate the safety of FT-2102 administered as monotherapy and in combination in 
patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation 
• 
Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-cancer 
agents 
• 
Evaluate additional measures of antitumor activity of FT-2102 as monotherapy and in 
combination with other anti-cancer agents  
Exploratory Objectives (Phase 1b and 2) 
• 
Evaluate potential biomarkers of response, resistance, and/or safety 
• 
Evaluate PD and PK/PD relationship of FT-2102 as a single agent and in combination 
with chemotherapy or immunotherapy 
• 
Evaluate the biological effects of FT-2102 on tumor tissue, including tumor cells, 
cerebrospinal fluid (CSF), immune cells, and vasculature  
• 
Assess IDH1 mutations in circulating tumor DNA (ctDNA) and correlate with mutations 
in tumor tissues 
• 
Evaluate the health-related quality of life (QOL)  
Study Endpoints: 
Primary Endpoint (Phase 1b): 
• 
DLTs (Safety Lead-in Periods), AEs, and safety laboratory values  
Primary Endpoint (Phase 2): 
• 
Objective response rate (ORR) as determined by applicable disease criteria, for disease-
specific cohorts 
Secondary Endpoints (Phases 1b and 2): 
• 
AEs, and safety laboratory values (Phase 2)  
• 
ORR (Phase 1b only) 


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• 
Progression-free survival (PFS), defined as the time from the first dose to disease 
progression as determined by applicable disease criteria or death due to any cause, 
whichever is sooner 
• 
Time to progression (TTP), defined as the time from start of treatment until disease 
specified progression 
• 
Duration of response (DOR), defined as the time from the first response to documented 
disease progression as determined by applicable disease criteria 
• 
Overall Survival (OS), defined as the time from the first dose to death due to any cause  
• 
Time to Response (TTR), defined as the time from first dose to first response  
• 
AEs and abnormal laboratory findings 
• 
PK parameters derived from plasma/CSF FT-2102 concentrations  
Exploratory Endpoints: 
• 
PD and PK/PD in relationship with clinical safety and clinical activity 
• 
Changes in 2-hydroxygluterate (2-HG) levels (PD biomarker) in plasma and tumor tissue 
(1H magnetic resonance spectroscopy [MRS] and CSF in intracranial gliomas and tumor 
biopsies for other tumors) 
• 
Characterization of biological effects of FT-2102 on tumor biopsies 
• 
Cancer-associated mutations and/or genetic alterations 
• 
IDH1 mutation in ctDNA 
• 
Health-related QOL patient-reported questionnaire (EQ5D) 
Inclusion Criteria: 
All patients must meet the following criteria for inclusion: 
1. ≥18 years of age 
2. Life expectancy of ≥4 months 
3. Able to provide tumor tissue sample (archival) 
4. Disease, defined as:  
Disease-Specific Cohorts 
• 
Glioma (Cohort 1) 
• 
Histologically or cytologically confirmed IDH1 gene-mutated advanced glioma that 
has recurred or progressed following standard therapy, or that has not responded to 
standard therapy with measurable disease 
• 
Glioblastoma multiforme with confirmed IDH1 gene-mutated disease with first or 
second recurrence with measurable disease 
• 
HBC (Cohort 2) 


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• 
Relapsed/refractory or intolerant to approved standard-of-care therapy (included: 
hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or 
other hepatobiliary carcinomas) 
• 
Histologically or cytologically confirmed IDH1 gene-mutated with measurable 
disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria 
• 
Child-Pugh Class A 
• 
Single Agent FT-2102: prior exposure to nivolumab is permitted 
• 
Combination Cohort 2b: patients may not have had prior exposure to nivolumab  
• 
Chondrosarcoma (Cohort 3) 
• 
Relapsed or refractory and either locally advanced or metastatic and not amenable to 
complete surgical excision 
• 
Histologically or cytologically confirmed IDH1 gene-mutated with measurable 
disease per RECIST 1.1 criteria 
• 
IHCC (Cohort 4) 
• 
Advanced nonresectable or metastatic intrahepatic cholangiocarcinoma not eligible 
for curative resection or transplantation.  
• 
Single-Agent/Safety Lead-in of Combination Phase 2: ineligible for standard 
therapies only 
• 
Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycle 
of GemCis therapy  
• 
Histologically or cytologically confirmed IDH1 gene-mutated with measurable 
disease per RECIST 1.1 criteria 
• 
Other tumors (non-CNS) (Cohort 5) 
• 
Relapsed or refractory to standard-of-care therapy with no other available therapeutic 
options 
• 
Histologically or cytologically confirmed IDH1 gene-mutated with measurable 
disease per disease appropriate response criteria 
5. Recovered to ≤Grade 2 or baseline toxicity (except alopecia) from prior therapy (per CTCAE 
v 4.03)  
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2  
7. Adequate bone marrow function 
• 
Absolute neutrophil count (ANC) ≥1.5 x 109/L without any growth factors in prior 
7 days  
• 
Hemoglobin ≥8.0 g/dL (with or without transfusion support) 
Platelet count ≥75 × 109/L (with or without transfusion support); Cohort 4b (GemCis 
combination): platelet count ≥100 × 109/L (with or without transfusion support) 


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8. Adequate hepatic function  
• 
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase) 
/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase) ≤2.5 × 
institutional upper limit of normal (ULN). For patients with suspected malignancy 
related elevations, <5 × ULN.  
• 
Total bilirubin ≤1.5 × ULN. For patients with suspected malignancy related elevation 
<3 × institutional ULN. Patients with Gilbert Syndrome <3 × ULN.   
9. Adequate renal function 
• 
Creatinine clearance per Cockcroft-Gault equation of ≥60 mL/min  
10. For women of childbearing potential (WCBP): negative serum β human chorionic 
gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP defined as 
a sexually mature woman who has not undergone surgical sterilization or who has not been 
naturally post-menopausal for at least 12 consecutive months for women >55 years of age) 
11. Willingness of male and female patients who are not surgically sterile or postmenopausal to 
use medically acceptable methods of birth control for the duration of the study treatment, 
including a period of time after study treatment completed:  
- 
FT-2102 only: 90 days 
- 
Nivolumab (female): 150 days 
- 
Nivolumab (male): 210 days 
- 
Azacitidine: 180 days 
- 
Gemcitabine/Cisplatin: 180 days  
Sexually active women using oral contraceptive pills, should also use barrier contraception. 
Males must agree not to donate sperm while participating in the study and for 90 days after the 
last dose of the study drug. For males receiving cisplatin, they must agree not to donate sperm 
while participating in the study and for 2 years following cisplatin.   
12. Ability to adhere to the study visit schedule and all protocol requirements 
13. Signed and dated IRB/independent ethics committee (IEC)-approved informed consent form 
before any screening procedures are performed 
Exclusion Criteria: 
Patients are to be excluded from the study if they meet any of the following criteria: 
1. Previous solid organ or hematopoietic cell transplant  
2. Less than the minimum time has elapsed from prior anticancer treatment to first dose of 
study treatment as follows:  
• 
Small molecule, antibody, or other anticancer therapeutic: 21 days (or 5 half-lives), 
whichever is shorter. Nitrosoureas or mitomycin C: 6 weeks.  For patients enrolling in 
the Phase 2 (beyond Safety Lead-in with IHCC): 14 days from GemCis therapy.    
• 
Prior radiation therapy (including radiofrequency ablation): 4 weeks  


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• 
Prior stereotactic body radiation therapy: 2 weeks  
• 
Prior chemoembolization or radioembolization:  4 weeks  
3. No previous treatment with an IDH1 inhibitor (single agent FT-2102 cohorts only)  
4. Congestive heart failure (New York Heart Association Class III or IV) or unstable 
angina pectoris; previous history of myocardial infarction within one year prior to 
study entry, uncontrolled hypertension, or uncontrolled arrhythmias 
5. History of QT prolongation or baseline QT interval corrected with Fridericia’s method 
(QTcF) >450 ms (average of triplicate readings) 
NOTE: criterion does not apply to patients with a right or left bundle branch block, a 
cardiology consult is recommended to assure that QTcF is not prolonged. 
6. Concomitant medication(s) associated with QTc interval prolongation or Torsades de Pointes 
(TdP) initiated less than the duration required to reach steady-state plasma concentration 
(approximately five half-lives) before first dose of study drug (see Appendix 3) (medications 
used as needed [PRN] (e.g., Zofran) are exempt).  
7. Pregnant or nursing women or WCBP not using adequate contraception; male patients not 
using adequate contraception  
8. Other malignancy within the last 5 years except: adequately treated non-melanoma skin 
cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ, stage 1, grade 
1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow 
involvement) curatively treated with no evidence of disease for ≥5 years 
9. Major surgery within 4 weeks of starting study treatment or not recovered from any effects of 
prior major surgery (uncomplicated central line placement or fine needle aspirate are not 
considered major surgery) 
10. Receipt of a live vaccine (including yellow fever vaccine) within 30 days of first day of study 
treatment 
11. Patients receiving >6 mg/day of dexamethasone or equivalent 
12. Patients with gastrointestinal disorders likely to interfere with absorption of the study 
medication  
13. Known human immunodeficiency virus positivity (HIV)  
14. Active infection with hepatitis B or C virus (Hep B or C viral load>100 international 
units/milliliter or local institutional equivalent) 
15. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable 
pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled 
diabetes) or any important medical or psychiatric illness or abnormal laboratory finding that 
would, in the Investigator’s judgment, increase the risk to the patient associated with his or 
her participation in the study. This includes any condition that would be considered a 
contraindication per local prescribing information to receipt of either azacitidine, nivolumab, 
gemcitabine or cisplatin based on cohort assigned (combination patients only).   
16. PD-1 combination only: 


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a. Patients with active autoimmune disease  
Note: patients with well controlled diabetes or hypothyroidism are eligible 
b. Patients with active infections, gastrointestinal tract bleeding, enterocleisis (colon 
obstruction) and severe colitis are excluded   
Statistical Methodology 
Sample Size Determination 
This study will enroll up to approximately 200 patients.  
A single-agent Safety Lead-in Period will be implemented that may enroll approximately 12 patients, 
which includes approximately 6 patients with glioma and 6 patients with solid tumors. Following 
successful completion of the Safety Lead-in Period, the study will then enroll 4 disease-specific 
cohorts examining FT-2102 as either single-agent or in combination. These cohorts include Cohort 1 
(glioma) with approximately 16-46  patients; Cohort 2 (HBC) with approximately 21-78 patients; 
Cohort 3 (chondrosarcoma) with up to 16-46 patients; and Cohort 4 (IHCC) with approximately 21-
77 patients.  There will be a fifth cohort of IDH1 mutant solid tumors, non-CNS with up to 6 patients, 
single-agent only. 
Cohort 1a, Cohort 2a, Cohort 3a (single-agent FT-2102) 
Cohorts 1a, 2a, and 3a will employ an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, 
power of 80%, null hypothesis of 5% ORR and alternative hypothesis of 25% ORR. Stage 1 of each 
single-agent cohort will evaluate 8 patients for efficacy over 4 treatment cycles; if there are 1 or more 
responses, Stage 2 will initiate with additional 15 patients. If there are 4 or more responses out of the 
total 23 patients, the null hypothesis of 5% ORR will be rejected. If there is no response in Stage 1 
with single-agent FT-2102, combination therapy may be evaluated.  
Cohort 4a (single-agent FT-2102) 
Cohort 4a employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 80%, 
null hypothesis of 8% ORR and alternative hypothesis of 35% ORR. Stage 1 will evaluate 8 patients 
and if there are 2 or more responses Stage 2 will initiate with additional 14 patients. If there are 5 or 
more responses out of the total 22 patients, the null hypothesis of 8% ORR will be rejected.  If there 
is 0 or 1 response in Stage 1 with single-agent FT-2102, combination may be evaluated. 
Combination Cohorts (1b, 2b, 3b, 4b)  
If there is no response in Stage 1 with single-agent FT-2102 combination cohorts may be examined. 
Cohort 1b and Cohort 3b 
For Cohorts 1b and 3b (combination therapy), an optimal Simon’s 2-Stage design will be 
implemented with a 1-sided alpha of 0.025, 80% power, with a null hypothesis of 5% ORR and 
alternative hypothesis of 25% ORR. Stage 1 of each cohort will evaluate 8 patients for efficacy over 
4 treatment cycles; if there are 1 or more responses, Stage 2 will initiate with additional 15 patients. 
If there are 4 or more responses out of the total 23 patients, the null hypothesis of 5% ORR will be 
rejected.  


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Cohort 2b  
Cohort 2b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 80%, 
null hypothesis of 20% ORR and alternative hypothesis of 40% ORR. Stage 1 will evaluate 13 
patients for efficacy; if there are 4 or more responses Stage 2 will initiate with an additional 42 
patients. If there are 17 or more responses out of the total 55 patients, the null hypothesis of 20% 
ORR will be rejected.   
Cohort 4b  
Cohort 4b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 80%, 
null hypothesis of 20% ORR and alternative hypothesis of 40% ORR. Stage 1 will evaluate 13 
patients and if there are 4 or more responses Stage 2 will initiate with additional 42 patients. If there 
are 17 or more responses out of the total 55 patients, the null hypothesis of 20% ORR will be 
rejected.   
Cohort 5a 
Cohort 5a, due to the diverse population, this is an exploratory cohort without pre-defined 
efficacy/futility determinations (n=6).  
Analysis Sets 
The DLT-Evaluable Analysis Set is defined as all patients in the Safety Lead-in Periods (single-
agent FT-2102, combination FT-2102 + 5-azacitidine, combination FT-2102 + GemCis, and 
combination FT-2102 + PD-1 inhibitor, nivolumab) who either experienced a DLT during Cycle 1 or 
completed at least 75% of the prescribed Cycle 1 dose. This analysis sets will be used to assess the 
tolerability of FT-2102.  
The Safety Analysis Set is defined as all patients who received any amount of study drug(s) (FT-
2102 and combination agents, if appropriate).  
This analysis set will be the primary analysis set for all safety endpoints, excluding DLT evaluation. 
Safety analysis will be by cohort and by treatment within cohort if more than 1 dose or dosing 
combination are initiated for a particular indication cohort. 
The Response-Evaluable Analysis Set is defined as all patients with measurable disease at baseline 
who received the study drug(s) specific to the part of their particular cohort (either FT-2102 
monotherapy or FT-2102 in combination) and had at least 1 post-baseline response assessment or 
discontinued the treatment phase due to disease progression (including death caused by disease 
progression) within 8 weeks (+2-week window) of the first dose of study treatment. This analysis set 
will be the primary analysis set for efficacy endpoints. All response evaluations will be by cohort, 
and by treatment within cohort if more than 1 doses or dosing combinations are initiated for a 
particular indication cohort. 
The PK Analysis Set is defined as patients from Stage 1 who have received at least one dose of FT-
2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUClast). 
The Pharmacodynamic Analysis Set is defined as all patients who received at least one dose of FT-
2102 and have completed at least one pharmacodynamic assessment.  
 


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Safety Analyses: 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 
version 19.0 or higher and will be graded according to the NCI CTCAE, v 4.03.  
For the Safety Lead-in Periods, the number and type of DLTs experienced by patients will be 
summarized for each dose level/combination, accompanied by a by-patient listing of DLT events. 
The listing will include the description, severity, and relationship of the events to study drug(s).  
Summaries of AEs will be based on treatment-emergent AEs (TEAEs). A TEAE is an AE that starts 
or worsens in the period from the first dose of study treatment to 28 days after the last dose of study 
drug (any of the combination agents, whichever is later). 
TEAEs will be summarized by cohort and dose level and by the frequency of patients experiencing 
TEAEs corresponding to MedDRA System Organ Classes (SOCs) and Preferred Terms (PTs). 
Separate tabulations will also be produced for TEAEs assessed as related to study drug(s), TEAEs 
that led to treatment discontinuation, TEAEs that led to death, and TEAEs ≥Grade 3 in severity. 
Treatment-emergent serious AEs (SAEs) and SAEs related to study drug(s) will also be tabulated.  
Shifts in grade from baseline to the maximum post-baseline grade will be summarized by dose level 
or treatment group for applicable laboratory data. Laboratory values ≥Grade 3 in severity will be 
tabulated by dose level or treatment group.  




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Table 1: 
Screening Assessments Checklista 
 
• 
Informed consent 
• 
Inclusion/exclusion criteria 
• 
Medical history & demographics 
• 
Cancer history 
• 
Prior/Concomitant medications & 
procedures  
• 
Full physical examination  
• 
ECOG performance status 
• 
ECG (12-lead)b  
• 
Blood chemistry including CrCl 
calculation  
• 
Hematology and coagulationc 
• 
Hepatitis B and Cd 
 
• 
Urinalysis  
• 
Serum β-hCG pregnancy teste 
• 
Tumor evaluationf 
• 
AE/SAE assessmentg 
• 
Slides/block of tumorh 
• 
IDH1 mutation assessmenti 
• 
Child-Pugh Score (HBC only) 
a) 
Screening performed ≤30 days from the first dose (C1D1). See Section 6.1 for details on each study assessment. 
b) 
12-lead ECG will be conducted following an approximate 10-minute rest period and obtained in triplicate within approximately a 5-minute time period. 
QTc measurements will use the Fridericia’s correction method (QTcF). ECGs will be read locally by the Investigator. 
c) 
CBC includes WBC, Hct, Hb, platelet, differential. Chemistries include: blood urea nitrogen, creatinine, glucose, AST, ALT, alkaline phosphatase, 
bilirubin (total and direct), electrolytes (sodium, chloride, bicarbonate, potassium), albumin, magnesium, calcium, phosphorus, and prothrombin time 
(HBC only), 
d) 
All patients will be tested for anti-hepatitis C antibody (anti-HCV) and hepatitis B surface antigen (HbsAg) at Screening. If hepatitis C antibody test is 
positive, then only patients with hepatitis C RNA <615 IU/L or 100 copies/mL per National Genetics Institute assay or local institutional standard will be 
eligible.    
e) 
For WCBP, the screening pregnancy test will be serum and must be performed within 7 days prior to the first dose to confirm eligibility.  
f) 
Quantification of baseline disease burden as applicable for disease type. The modality chosen to evaluate each individual patient should be the same 
throughout the duration of the study. For patients with glioma at sites participating in magnetic resonance spectroscopy, a baseline study should be 
performed. 
g) 
For all patients, AEs should be monitored from signing of the ICF through 28 days post last dose (whichever is dosed last) or until the patient is determined 
to be a screen failure. After completion of the initial screening assessments, any new clinically significant findings for enrolled patients will be captured as 
an AE on the electronic case report form. SAEs for all patients will be reported from the time of the signing of the ICF until 28 days post last dose of FT-
2102 or combination therapy agent (whichever is dosed last). At any time after completion of the AE reporting period, if an Investigator becomes aware of 
an SAE that is suspected by the Investigator to be related to any study drug, the event must be reported. 
h) 
Most recent tumor sample, in the form of FFPE block or cut slides, and accompanying pathology report for all patients to be submitted centrally.  
i) 
IDH1 mutation testing and method per local standards. For patients with tumors of unknown IDH1 mutation status, contact Medical Monitor. 
 
 


















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n. 
Survival follow-up assessments will occur every 3 months following documented disease progression or start of a new cancer therapy for 24 months after the first 
dose of FT-2102. These assessments may be conducted by telephone interview. Information on initiation of other anticancer therapy (including start date, therapy 
type/name, and response on treatment) will be collected. Additional survival follow-up calls may occur periodically if needed for data analysis. 








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1 TABLE OF CONTENTS 
INVESTIGATOR PROTOCOL APPROVAL ................................................................................2 
SPONSOR SIGNATURE PAGE ....................................................................................................3 
CONTACT INFORMATION ..........................................................................................................3 
SERIOUS ADVERSE EVENT REPORTING ................................................................................4 
PROTOCOL SYNOPSIS.................................................................................................................5 
1 
TABLE OF CONTENTS ...........................................................................................35 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................41 
1. 
BACKGROUND ........................................................................................................45 
1.1. 
IDH1 R132X Mutations .............................................................................................45 
1.2. 
FT-2102 ......................................................................................................................45 
1.2.1. 
Preclinical Summary ...................................................................................................45 
1.2.2. 
Clinical Summary .......................................................................................................46 
1.3. 
Study Rationale ...........................................................................................................46 
1.3.1. 
Selection of Patient Populations .................................................................................46 
1.4. 
Determination of Starting Doses and Regimen ..........................................................47 
1.4.1. 
Single-Agent FT-2102 ................................................................................................47 
1.4.2. 
FT-2102 in Combination with Azacitidine .................................................................48 
1.4.3. 
FT-2102 in Combination with Nivolumab .................................................................48 
1.4.4. 
FT-2102 in Combination with GemCis ......................................................................49 
2. 
OBJECTIVES .............................................................................................................50 
2.1. 
Primary Objectives .....................................................................................................50 
2.1.1. 
Phase 1b ......................................................................................................................50 
2.1.2. 
Phase 2 ........................................................................................................................50 
2.2. 
Secondary Objectives .................................................................................................50 
2.2.1. 
Phase 1b ......................................................................................................................50 
2.2.2. 
Phase 2 ........................................................................................................................50 
2.3. 
Exploratory Objectives (Phases 1b and 2) ..................................................................50 
3. 
ENDPOINTS ..............................................................................................................51 
3.1. 
Primary Endpoints ......................................................................................................51 
3.1.1. 
Phase 1b ......................................................................................................................51 


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3.1.2. 
Phase 2 ........................................................................................................................51 
3.2. 
Secondary Endpoints (Phases 1b and 2) .....................................................................51 
3.3. 
Exploratory Endpoints (Phases 1b and 2) ...................................................................51 
4. 
STUDY DESIGN .......................................................................................................52 
4.1. 
Safety Lead-in Period: Phase 1b .................................................................................52 
4.1.1. 
Single-Agent ...............................................................................................................52 
4.1.2. 
Combination ...............................................................................................................52 
4.1.3. 
Safety Review Committee ..........................................................................................54 
4.1.4. 
Dosing Frequency .......................................................................................................54 
4.2. 
Disease-Specific Cohorts: Phase 2 .............................................................................55 
4.2.1. 
Cohort 1: Glioma (n=16-46) .......................................................................................55 
4.2.2. 
Cohort 2: HBC (n=21-78) ...........................................................................................56 
4.2.3. 
Cohort 3: Chondrosarcoma (n=16-46)........................................................................56 
4.2.4. 
Cohort 4: Cholangiocarcinoma (n=21-77) ..................................................................57 
4.2.5. 
Cohort 5a: Other Non-CNS Solid Tumors with IDH1 Mutations (n=6) ....................57 
4.3. 
Monitoring of Adverse Events: ..................................................................................57 
4.4. 
DLTs ...........................................................................................................................57 
4.4.1. 
Single-Agent Safety Lead-in ......................................................................................57 
4.4.2. 
Combination Therapy Safety Lead-in ........................................................................58 
4.5. 
Treatment Discontinuation .........................................................................................59 
4.6. 
Study Withdrawal and Study Completion ..................................................................60 
5. 
STUDY POPULATION .............................................................................................61 
5.1. 
Inclusion Criteria ........................................................................................................61 
5.2. 
Exclusion Criteria .......................................................................................................64 
6. 
STUDY PROCEDURES AND ASSESSMENTS ......................................................66 
6.1. 
Screening Assessments ...............................................................................................66 
6.1.1. 
Informed Consent .......................................................................................................66 
6.1.2. 
Inclusion and Exclusion Criteria ................................................................................66 
6.1.3. 
Medical History, Demographics, and Cancer History ................................................67 
6.1.4. 
Prior/Concomitant Medications and Procedures ........................................................67 
6.1.5. 
Physical Exam ............................................................................................................67 
6.1.6. 
Eastern Cooperative Oncology Group Performance Status ........................................67 
6.1.7. 
Electrocardiogram .......................................................................................................67 


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6.1.8. 
Clinical Laboratory Tests ...........................................................................................67 
6.1.9. 
Additional Screening Laboratory Measurements .......................................................68 
6.1.10. 
Urinalysis ....................................................................................................................68 
6.1.11. 
Tumor Evaluation .......................................................................................................68 
6.1.12. 
Tumor Biopsy .............................................................................................................68 
6.1.13. 
Adverse Events ...........................................................................................................69 
6.2. 
Safety Assessments .....................................................................................................69 
6.2.1. 
Concomitant Medication and Therapies .....................................................................69 
6.2.2. 
Adverse Events ...........................................................................................................69 
6.3. 
Response Assessment Procedures ..............................................................................69 
6.3.1. 
Response Evaluation Criteria .....................................................................................69 
6.4. 
Other Study Procedures ..............................................................................................70 
6.4.1. 
Study Drug Administration .........................................................................................70 
6.4.2. 
Pharmacokinetic Sampling .........................................................................................70 
6.4.3. 
Pharmacodynamic Sampling ......................................................................................70 
6.4.4. 
Biomarker Assessments ..............................................................................................71 
6.4.5. 
Tumor Biopsy .............................................................................................................71 
6.4.6. 
Lumbar Puncture ........................................................................................................71 
6.4.7. 
Quality of Life (EQSD) ..............................................................................................71 
6.4.8. 
Magnetic Resonance Spectroscopy for 2-HG .............................................................71 
6.4.9. 
Additional Exploratory biomarkers ............................................................................71 
6.5. 
Safety Follow-up Visit ................................................................................................71 
6.6. 
Safety Follow-up ........................................................................................................71 
6.7. 
Concomitant Medications ...........................................................................................72 
6.7.1. 
Prohibited: Other Anticancer Therapy or Investigational Agents ..............................72 
6.7.2. 
Other Concomitant Therapies .....................................................................................72 
6.8. 
Precautions ..................................................................................................................72 
6.8.1. 
Differentiation Syndrome ...........................................................................................72 
6.8.2. 
Hepatic Injury .............................................................................................................73 
6.8.3. 
Phototoxicity ...............................................................................................................74 
6.8.4. 
Childbearing Potential ................................................................................................74 
7. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................77 
7.1. 
FT-2102 ......................................................................................................................77 


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7.1.1. 
Dosage ........................................................................................................................77 
7.1.2. 
Administration ............................................................................................................77 
7.1.3. 
Storage ........................................................................................................................78 
7.2. 
5-azacitidine ................................................................................................................78 
7.2.1. 
Dosage ........................................................................................................................78 
7.2.2. 
Administration ............................................................................................................78 
7.2.3. 
Storage ........................................................................................................................78 
7.3. 
PD-1 Inhibitor (Nivolumab) .......................................................................................78 
7.3.1. 
Dosage ........................................................................................................................79 
7.3.2. 
Administration ............................................................................................................79 
7.3.3. 
Storage ........................................................................................................................79 
7.4. 
Gemcitabine/Cisplatin (GemCis) ................................................................................79 
7.4.1. 
Dosage ........................................................................................................................79 
7.4.2. 
Administration ............................................................................................................79 
7.4.3. 
Storage ........................................................................................................................79 
7.5. 
Dose Holds, Modifications, and Discontinuations .....................................................80 
7.5.1. 
Dose Holds and Modifications ...................................................................................80 
7.6. 
Drug Accountability ...................................................................................................85 
7.7. 
Assignment to Treatment ............................................................................................85 
8. 
SAFETY DATA COLLECTION, RECORDING, AND REPORTING ....................86 
8.1. 
Adverse Events ...........................................................................................................86 
8.1.1. 
Definition of an Adverse Event ..................................................................................86 
8.1.2. 
Definition of Serious Adverse Event ..........................................................................86 
8.2. 
Procedures for Recording, and Reporting Adverse Events ........................................87 
8.2.1. 
Recording Adverse Events .........................................................................................87 
8.2.2. 
Reporting of Serious Adverse Events .........................................................................89 
8.2.3. 
Reporting of Adverse Events of Special Interest ........................................................90 
8.2.4. 
Pregnancy and In Utero Drug Exposure .....................................................................90 
8.2.5. 
Disease Progression ....................................................................................................91 
9. 
STATISTICAL METHODS .......................................................................................92 
9.1. 
Sample Size ................................................................................................................92 
9.2. 
Analysis Sets ...............................................................................................................93 
9.2.1. 
Dose-Limiting Toxicity-Evaluable Analysis Set ........................................................93 


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9.2.2. 
Safety Analysis Set .....................................................................................................93 
9.2.3. 
Response-Evaluable Analysis Set ...............................................................................93 
9.2.4. 
Pharmacokinetics Analysis Set ...................................................................................94 
9.2.5. 
Pharmacodynamics Analysis Set ................................................................................94 
9.3. 
Background Characteristics ........................................................................................94 
9.3.1. 
Patient Disposition ......................................................................................................94 
9.3.2. 
Demographics and Baseline Characteristics ...............................................................94 
9.4. 
Study Drug Exposure and Compliance .......................................................................94 
9.5. 
Efficacy Analyses .......................................................................................................94 
9.6. 
Safety Analyses ..........................................................................................................96 
9.6.1. 
Adverse Events ...........................................................................................................96 
9.6.2. 
Clinical Laboratory Assessments ...............................................................................96 
9.6.3. 
Electrocardiogram .......................................................................................................96 
9.7. 
Pharmacokinetic Analyses ..........................................................................................97 
9.8. 
Pharmacodynamic Analyses .......................................................................................97 
10. 
STUDY ADMINISTRATION ...................................................................................98 
10.1. 
Good Clinical Practice Statement ...............................................................................98 
10.2. 
Informed Consent .......................................................................................................98 
10.3. 
Patient Confidentiality ................................................................................................98 
10.4. 
Institutional Review Board/Ethics Committee Requirements ....................................99 
10.5. 
Case Report Forms and Source Documentation .........................................................99 
10.6. 
Sponsor Monitoring ....................................................................................................99 
10.7. 
Data Monitoring Committee .....................................................................................100 
10.8. 
Quality Assurance .....................................................................................................100 
10.9. 
Study or Clinical Site Termination ...........................................................................100 
10.10. 
Duration of the Study, Expected Duration of Patient Participation, and End 
of Study .....................................................................................................................100 
10.11. 
Records Retention .....................................................................................................100 
10.12. 
Publications ...............................................................................................................101 
11. 
REFERENCES .........................................................................................................102 
12. 
APPENDICES ..........................................................................................................105 
APPENDIX 1. EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE 
STATUS ...................................................................................................................106 


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APPENDIX 2. RESPONSE CRITERIA ...................................................................................107 
APPENDIX 3. DRUGS AFFECTING QTC INTERVAL........................................................111 
APPENDIX 4. CHILD-PUGH SCORE ....................................................................................112 
APPENDIX 5. DRUGS THAT ARE SENSITIVE SUBSTRATES OR STRONG 
INDUCERS OF CYP3A4 .........................................................................................113 
 
LIST OF TABLES 
Table 1: 
Screening Assessments Checklista ..............................................................................22 
Table 2: 
Schedule of Assessments: Single-Agent FT-2102 (Safety Lead-in, Cohorts 
1a, 2a, 3a, 4a, and 5a) .................................................................................................23 
Table 3: 
Schedule of Assessments: FT-2102 + 5-Azacitidine (Cohort 1b [Glioma] and 
Cohort 3b [Chondrosarcoma]) ....................................................................................25 
Table 4: 
Schedule of Assessments: FT-2102 + PD-1 Inhibitor (Nivolumab) (Cohort 
2b [HBC]) ...................................................................................................................27 
Table 5: 
Schedule of Assessments: FT-2102 + Chemotherapy (GemCis) (Cohort 4b 
IHCC) .........................................................................................................................29 
Table 6: 
Schedule of Pharmacokinetics (PK), PD (2-HG), and Electrocardiogram 
Assessments  (Safety Lead-in, Cohort 5a and Stage 1 of Each Cohort: 
Single-Agent and Combination) .................................................................................32 
Table 7: 
Schedule of Pharmacokinetics (PK), PD (2-HG), and Electrocardiogram 
Assessments (Stage 2 of Each Cohort: Single-Agent and Combination) ...................33 
Table 8: 
Schedule of Efficacy and Biomarker Assessments (by Cohort) .................................34 
Table 9: 
Dose Levels for FT-2102 + Azacitidine .....................................................................53 
Table 10: Dose Levels for FT-2102 + Gemcitabine/Cisplatin ....................................................53 
Table 11: Dose Levels for FT-2102 + Nivolumab ......................................................................54 
Table 12: FT-2102 Recommended Dose Modifications for Toxicities Unrelated to 
Liver Function Abnormalities .....................................................................................81 
Table 13: FT-2102 Recommended Dose Modifications for Liver Function 
Abnormalities .............................................................................................................81 
Table 14: Dose Modifications for Nivolumab Toxicities ...........................................................83 
Table 15: Drugs that Prolong the QT Interval and/or Have a Risk of Inducing Torsade 
De Pointes .................................................................................................................111 
 
LIST OF FIGURES 
Figure 1: 
Study Schematic .........................................................................................................21 
 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
2-HG 
2-hydroxygluterate 
α-KG 
alpha-ketoglutarate  
ADL 
activities of daily living 
AE 
adverse event 
AESI 
adverse event(s) of special interest 
ALT 
alanine aminotransferase 
AML 
acute myelogenous leukemia 
ANC 
absolute neutrophil count 
anti-HCV 
anti-hepatitis C antibody  
API 
active pharmaceutical ingredient 
AST/SGOT 
aspartate aminotransferase 
AT 
All-Treated 
AUC0-last   
area under the plasma concentration-time curve from time zero to the 
last quantifiable time point  
AUC0-INF  
area under the plasma concentration-time curve from time zero 
extrapolated to infinity  
β-hCG  
beta-human chorionic gonadotropin 
BID 
twice daily 
BUN 
blood urea nitrogen 
CBC 
complete blood count 
CEC 
Central Ethics Committee 
CIRB 
Central Institutional Review Board 
Cmax  
maximum observed plasma concentration  
CNS 
central nervous system 
CR  
complete response/remission 
CSF 
cerebrospinal fluid 
ctDNA 
Circulating tumor DNA 
DNA 
deoxyribonucleic acid 
DLT 
dose-limiting toxicity 
DOR 
duration of response 
ECG 
electrocardiogram 


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Abbreviation 
Definition 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EFD 
embryo-fetal developmental 
EoT 
End of Treatment 
FFPE 
formalin-fixed, paraffin-embedded 
GCP 
Good Clinical Practice 
GemCis 
gemcitabine and cisplatin 
HBC 
hepatobiliary cancer 
hBsAg 
hepatitis B surface antigen 
HIV 
human immunodeficiency virus  
IB 
Investigator Brochure 
IC50 
half maximal inhibitory concentration  
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IDH1 
isocitrate dehydrogenase 1 
IDH2 
isocitrate dehydrogenase 2 
IHCC 
intrahepatic cholangiocarcinoma 
IEC 
independent ethics committee 
INR/PT 
international normalized ratio/prothrombin time 
IRB 
institutional review board 
IUD 
intrauterine device 
IV 
intravenous 
KPS 
Karnofsky Performance Status 
LC/MS/MS 
liquid chromatography-tandem mass spectrometry  
LDH 
lactate dehydrogenase 
LEC 
Local Ethics Committee 
LFT 
liver function test 
LGG 
low-grade glioma 
LPLV 
last patient last visit 
MDS 
myelodysplastic syndrome 
MedDRA 
Medical Dictionary for Regulatory Activities 
MR 
minor response 


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Abbreviation 
Definition 
MRI 
magnetic resonance imaging 
MRS 
magnetic resonance spectroscopy 
NCI CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse 
Events 
ORR 
objective response rate 
OS 
overall survival 
PD-1 
programmed death-1 
PD 
pharmacodynamic  
PE 
physical examination 
PFS 
progression-free survival 
PI 
Principal Investigator  
PK 
pharmacokinetic(s) 
PR 
partial response/remission 
PRN 
as needed 
PT 
Preferred Term 
PT/aPTT 
Prothrombin time/activated partial thromboplastin time 
QOL 
quality of life 
QTcF 
QT interval corrected with Fridericia’s method 
RANO 
Revised Assessment in Neuro-Oncology 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RP2D 
recommended Phase 2 dose 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOC 
System Organ Class 
SRC 
Safety Review Committee 
t1/2   
terminal elimination half-life  
TEAE 
treatment-emergent adverse event 
TdP 
Torsades de Pointes 
tmax  
time of maximum observed plasma concentration  
TTP 
time to progression 
TTR 
time to response 
ULN 
upper limit of normal 


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Abbreviation 
Definition 
WBC 
white blood cell 
WCBP 
women of childbearing potential 
WHO 
World Health Organization 






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In addition to IDH inhibitors, demethylating agents have demonstrated reduction of methylation 
and growth inhibition in IDH1 mutant glioma xenografts and patient derived glioma initiator 
cells (Borodovsky et al, 2013; Turcan et al, 2013). An investigation of single-agent IDH1 
inhibitor and combination therapy with a demethylating agent with known safety profile, 
azacitidine, is proposed in the clinical study.  
IDH1 mutations have been reported in a subset of clear cell hepatocellular carcinoma and 
associated with poor prognosis in a single center investigation (Lee et al, 2017). Histone 
modification and epigenetic DNA methylation has been demonstrated to repress tumor Th1-type 
chemokines and subsequently determine effector T-cell trafficking into the tumor 
microenvironment (Peng et al, 2015). Thus, cancer epigenetic reprograming may remove Th1-
type chemokine repressive marks and promote effector T-cell trafficking into the tumor 
microenvironment and improve the therapeutic efficacy of PD-1 immune checkpoint blockade. 
The PD-1 inhibitor, nivolumab, has demonstrated clinical activity in advanced hepatocellular 
carcinoma (El-Khoueiry et al, 2017). The proposed clinical study investigates single-agent FT-
2102, then possibly in combination with nivolumab in patients with HBC with the R132X IDH1 
mutation.  
Mutations of the IDH1/2 genes are present in up to 50% of chondrosarcomas and reported with 
the enchondromatosis-associated non-hereditary Maffucci and Ollier syndromes, suggesting that 
the IDH mutation may represent an early tumorigenic event (Amary et al, 2011; Meijer et al, 
2012). IDH mutations have been shown to create a hypermethylation phenotype in 
chondrosarcoma cells which may be reversed with demethylating agents, 5-azacitidine (Lu et al, 
2012). The proposed clinical study will evaluate single-agent FT-2102 followed by a 
combination with 5-azacitidine for patients with relapsed or refractory chondrosarcoma with an 
IDH1 mutation. For patients with locally advanced or metastatic biliary cancer including IHCC, 
the current standard of care includes combination chemotherapy with gemcitabine and cisplatin 
(Valle et al, 2010) with a short duration of progression free survival (PFS; 8.0 months, CI: 
6.6-8.6 months) and overall survival (OS) of 11.7 months (CI: 9.5-14.3 months). Other 
combination agents have been evaluated with comparable PFS and OS (Eckmann et al, 2011). As 
IDH mutations have been reported to occur in up to 25% of IHCC (Goyal et al, 2015), an 
evaluation of FT-2102 as a single agent followed by combination with gemcitabine + cisplatin 
for patients with advanced unresectable IHCC is proposed. 
1.4. 
Determination of Starting Doses and Regimen 
1.4.1. 
Single-Agent FT-2102 
Clinical Study 2102-HEM-101 is an ongoing Phase 1/2 investigation in patients with advanced 
hematologic malignancies with IDH1 mutations. In this study, dose escalation was initiated using 
FT-2102 as a single agent in AML or MDS patients harboring an IDH1-R132 mutation, as 
determined by local mutation testing. FT-2102 doses of 150, 300 mg QD and 150 mg BID have 
been evaluated. FT-2102 is administered orally in continuous 28-day cycles. There were no 
DLTs observed at any doses and an MTD was not determined. The Phase 1 single-agent study 
has been completed and a review of available safety data, including all adverse events (AEs) 
reported in patients treated with the 150 mg BID dose concluded that the safety profile was 
consistent with that of patients treated in dose escalation; no new safety signals were observed in 
the expansion cohorts.  


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Based on this review, in combination with achievement of targeted 2-HG depletion in plasma 
and preliminary pharmacokinetics (PK), FT-2102 150 mg BID was declared the RP2D for 
further evaluation in hematologic malignancies (additional details in the IB).   
As part of the safety evaluation of the combinations, in each combination cohort, there will be a 
3+3 design, safety evaluation of the first patients enrolled in each combination cohort.    
1.4.2. 
FT-2102 in Combination with Azacitidine 
There have been extensive evaluations of azacitidine in patients with hematologic malignancies 
leading to the currently approved dose is 75 mg/m2/day × 7 days delivered either subcutaneously 
or intravenously every 28 days (VIDAZA US Prescribing Information). In the Clinical Study 
2102-HEM-101, as of 7-April-2018, 26 patients with advanced hematologic malignancies 
received FT-2102 in combination with azacitidine at 75 mg/m2/day × 7 days every 28 days (20 
patients: FT-2102 at 150 mg BID; 7 patients: FT-2102 at 150 mg QD).  When given in 
combination, when compared to single-agent FT-2102, there were additional gastrointestinal 
toxicities noted in combination (nausea, constipation, and diarrhea) and electrolyte abnormalities 
(hypokalemia and hypophosphatemia) which are known toxicities of azacitidine (additional 
details in IB and azacytidine PI (VIDAZA US Prescribing Information). 
Clinical investigations of azacitidine in solid tumors however are quite limited. Jeurgens 
evaluated the combination of a novel histone deacetylase inhibitor, entinostat, with azacitidine 
dosed at either 30 mg/m2/day or 40 mg/m2/day × 10 days (with a 48-hour interruption at Day 6) 
in patients with relapsed/refractory non-small cell lung carcinoma. The Investigators concluded 
that 40 g/m2/day is a tolerable dose in this small subset of patients (Juergens et al, 2011). A meta-
analysis of 11 clinical studies in a total of 694 patients with a variety of solid tumors found 
response plus stable disease rates of ~35% in breast, colorectal and pancreatic cancers.  The 
authors found that intravenous dosing was supported by the available data (not subcutaneous) 
and that 67.5 mg/m2/day correlated favorably with response rates in gastrointestinal (GI), lung 
and breast cancer (Cowan et al, 2010). Thus, the proposed study will investigate initially in a 3+3 
dose confirmation an azacitidine dose of 75 mg/m2/day for a total of 7 doses permitting a 48-
hour window as needed for patient convenience. If there is toxicity at that dose, additional doses 
will be investigated.  If the patient has intolerance to azacitidine, they can continue with FT-2102 
as a single agent.  
1.4.3. 
FT-2102 in Combination with Nivolumab 
The dose of the PD-1 inhibitor, nivolumab is based upon the Food and Drug Administration 
(FDA) approved dose for hepatocellular carcinoma, specifically 240 mg IV every 2 weeks. This 
dose will be the basis for sites where nivolumab is not approved for hepatocellular carcinoma. If 
the patient is intolerant of nivolumab, they can continue on single-agent FT-2102. Clinical 
experience to date with FT-2102 includes as a single agent or in combination with azacitidine.  
Based on the mechanism of action of nivolumab and FT-2102, it is not anticipated that there will 
be overlapping toxicities, but it is unknown at this time.  
 


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1.4.4. 
FT-2102 in Combination with GemCis 
The dose of gemcitabine/cisplatin is based upon the standard of care regimen established by 
Valle and colleagues (Valle et al, 2010) and a reasonable global standard in a review by Weber 
and colleagues (Weber et al, 2015): cisplatin (25 mg/m2) followed by gemcitabine (1000 mg/m2), 
each administered on Days 1 and 8, every 3 weeks for eight cycles for up to 24 weeks. For 
patient convenience and data analysis, cycle duration will be 28 days +/- 7 days when 
gemcitabine/cisplatin is being given with FT-2102. Following completion of the 24 weeks of 
therapy or if intolerant of either agent, the patient can continue on single-agent FT-2102 with 
28-day cycles. Clinical experience to date with FT-2102 includes as a single agent or in 
combination with azacitidine. Based on the mechanism of action of gemcitabine, cisplatin and 
FT-2102, it is anticipated that there may be overlapping toxicities (myelosuppression and/or 
hepatic toxicity) but it is unknown at this time. 
 


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2. 
OBJECTIVES 
2.1. 
Primary Objectives 
2.1.1. 
Phase 1b 
• Evaluate the safety and tolerability of FT-2102 as monotherapy and confirm the dose 
to be further examined in expansion cohorts as monotherapy and combination therapy  
2.1.2. 
Phase 2 
• Evaluate the clinical activity of FT-2102 as a monotherapy or in combination in 
patients with glioma, hepatobiliary cancer (HBC), chondrosarcoma, and IHCC 
harboring an IDH1 mutation 
2.2. 
Secondary Objectives  
2.2.1. 
Phase 1b 
• Evaluate the PK of FT-2102 as single agent and in combination with other anti-cancer 
agents 
• Evaluate the clinical activity of FT-2102 as a single agent or in combination in 
patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation 
2.2.2. 
Phase 2 
• Evaluate the safety of FT-2102 administered as monotherapy and in combination with 
other anti-cancer agents in patients with glioma, HBC, chondrosarcoma, and IHCC 
harboring an IDH1 mutation 
• Evaluate the PK of FT-2102 as single agent and in combination with other anti-cancer 
agents 
• Evaluate additional measures of antitumor activity of FT-2102 as a single agent or in 
combination with other anti-cancer agents 
2.3. 
Exploratory Objectives (Phases 1b and 2) 
• Evaluate potential biomarkers of response, resistance, and/or safety 
• Evaluate pharmacodynamic (PD) and PK/PD relationship of FT-2102 as 
monotherapy and in combination with other anti-cancer agents 
• Evaluate the biological effects of FT-2102 on tumor tissue, including tumor cells, 
CSF, immune cells, and vasculature  
• Evaluate the biological effects of FT-2102 on tumor tissue, including tumor cells, 
CSF, immune cells, and vasculature  
• Assess IDH1 mutations in ctDNA and correlate with mutations in tumor tissues 
• Evaluate the health-related quality of life (QOL)  


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3. 
ENDPOINTS 
3.1. 
Primary Endpoints  
3.1.1. 
Phase 1b 
• DLTs (Safety Lead-in Periods), adverse event (AEs), and safety laboratory values  
3.1.2. 
Phase 2 
• Objective response rate (ORR), as determined by applicable disease criteria, for 
disease-specific cohorts 
3.2. 
Secondary Endpoints (Phases 1b and 2) 
• AEs, and safety laboratory values (Phase 2)  
• ORR (Phase 1b only) 
• PFS, defined as the time from the first dose to disease progression as determined by 
applicable disease criteria or death due to any cause, whichever is sooner 
• Time to progression (TTP), defined as the time from start of treatment until disease 
specified progression 
• Duration of response (DOR), defined as the time from the first response to 
documented disease progression as determined by applicable disease criteria 
• OS, defined as the time from the first dose to death due to any cause  
• Time to Response (TTR), defined as the time from first dose to first response AEs 
and abnormal laboratory findings 
• PK parameters derived from plasma/cerebrospinal fluid (CSF) FT-2102 
concentrations  
3.3. 
Exploratory Endpoints (Phases 1b and 2) 
• PD and PK/PD in relationship with clinical safety and clinical activity 
• Changes in 2-hyroxygluterate (2-HG levels) (PD, biomarker) in plasma and tumor 
tissue (1H magnetic resonance spectroscopy (MRS) and CSF in intracranial gliomas 
and tumor biopsies for other tumors) 
• Characterization of biological effects of FT-2102 on tumor biopsies 
• Cancer-associated mutations and/or genetic alterations 
• IDH1 mutation in ctDNA 
• Health-related QOL patient-reported questionnaire (EQ5D) 


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4. 
STUDY DESIGN 
This is a multicenter, Phase 1b/2, open-label, multiple-cohort study examining the efficacy and 
safety of FT-2102 as a single agent or in combination for the treatment of patients with advanced 
solid tumors and gliomas with IDH1 R132X mutations.  
Please see Figure 1 for an overview of the study. The starting dose of FT-2102 is 150 mg BID 
administered continuously in 28-day cycles; the selection of the starting dose is based on results 
from a Phase 1 study in patients with hematologic malignancies. 
4.1. 
Safety Lead-in Period: Phase 1b  
4.1.1. 
Single-Agent 
The study will consist of a Safety Lead-in Period to confirm the safety and tolerability of single-
agent FT-2102 150 mg BID administered over 28 days (1 cycle). The Safety-Lead-in Period will 
employ a traditional 3+3 design, whereby 3 patients with any of the solid tumors (Cohorts 2a-5a) 
and 3 patients with gliomas (Cohort 1a) are treated with FT-2102 150 mg BID and monitored for 
DLTs during the first cycle of study treatment.  
• If no DLTs occur in the first 3 patients in either the solid tumor group (Cohorts 2a-5a) 
or the glioma group (Cohort 1a), and available PK/PD data support the dose, 
enrollment will continue in the 4 disease-specific cohorts described below.  
• If a DLT occurs in the first 3 patients in either group, an additional 3 patients will be 
treated at that dose level in either the solid tumor group (Cohorts 2a-5a) or the glioma 
group (Cohort 1a). If no DLTs occur in these additional 3 patients (ie, <2 DLTs per 
6 patients) and available PK/PD data support the dose, enrollment will continue in the 
4 disease-specific cohorts described below.  
• If there are ≥2 DLTs at the starting dose, 150 mg once daily of FT-2102 will be 
evaluated following review by the Safety Review Committee (SRC). Likewise, higher 
doses may be evaluated based upon safety, PK, and PD data as determined by the 
SRC. 
The 3+3 design of the Safety Lead-in period is based on DLT evaluable patients.  If a patient 
enrolls in this phase, but does not qualify as DLT evaluable, that patient will be replaced. 
4.1.2. 
Combination 
DLTs will be evaluated within the first 3 (or 6) patients of any cohort examining combination 
therapy to confirm the safety and tolerability of combination therapy administered over 28 days 
(1 cycle) for Cohort 1b, Cohort 2b, Cohort 3b, and Cohort 4b using a 3+3 design (ie, up to the 
first 6 patients in each combination cohort).  The cohort will be stopped if there is more than 1 
DLT out of the first 6 patients, and additional dose levels will be evaluated as follows:  
• If no DLTs occur in the first 3 patients in a combination cohort and available PK/PD 
data support the dose, enrollment will continue in the that disease-specific cohort.  
• If a DLT occurs in the first 3 patients in a combination cohort, an additional 3 patients 
will be treated at that dose level. If no DLTs occur in these additional 3 patients (ie, 






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during Part 1 of each cohort and may recommend altering the dosing paradigm based on 
available data. The SRC will conduct an aggregate assessment of PK/PD data as well as a review 
of the study drug-related AEs to ensure that the combination therapies is safe and well tolerated. 
4.2. 
Disease-Specific Cohorts: Phase 2  
Four disease-specific cohorts will employ a Simon’s 2-stage-wise design, whereby 8 patients in 
the first stage of each cohort will be treated with study therapy (either single-agent FT-2102 or in 
combination with antineoplastic agents) and evaluated for efficacy and safety. After up to 
8 patients in Stage 1 have been evaluated for at least 4 cycles of study treatment, disease-specific 
efficacy data will be evaluated to determine continued enrollment to Stage 2. Enrollment will 
continue during the Stage 1 evaluation. If Stage 1 efficacy criteria from any single-agent  
FT-2102 cohort is not met, then examination of combination therapy will be initiated in a new 
Simon’s 2-stage design. Combination therapy in cohorts 1-4 may also be examined in the event 
that the single agent cohort passes the futility analysis and the enrollment in the single agent 
cohort is completed. 
Safety data from Stage 1 will also be reviewed on an ongoing basis by SRC. Significant safety 
findings may lead to an early stopping for any cohort and will be considered when deciding to 
initiate Stage 2 of any cohort.  The Simon’s 2-stage design is based upon Response Evaluable 
population.  Patients who are not in the Response Evaluable population will not be counted in the 
numerator or denominator of the number of patients needed in Phase 2. 
For the Safety Lead-in Period and Stage 1 of each disease-specific cohort, blood samples for PK 
and PD will be obtained. Limited PK and PD samples will be obtained during Stage 2.    
4.2.1. 
Cohort 1: Glioma (n=16-46) 
Cohort 1 will include patients with glioma harboring an IDH1 R132X mutation that is relapsed 
or refractory. Glioma patients will be initially treated with single-agent FT-2102 (Cohort 1a). 
Cohort 1a will employ a Simon’s 2-stage design, in which 8 patients will be treated with single-
agent FT-2102 for 4 cycles (cycle=28 days) and assessed for efficacy and safety (Stage 1).  
If ≥1 clinical response is observed in Stage 1, then Stage 2 (n=15) will initiate with single-agent 
FT-2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination 
therapy may be examined (FT-2102 + 5-azacitidine) (Cohort 1b).  
Cohort 1b will employ the same Simon’s 2-stage design, enrolling 8 evaluable patients in Stage 1 
and 15 evaluable patients in Stage 2 with combination therapy. 
If ≥1 clinical responses are observed in Stage 1 of Cohort 1b, then Stage 2 (n=15) will be 
initiated with combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any glioma patients enrolled in the Safety Lead-in Period will be considered part of 
Stage 1 enrollment for single-agent or combination treatment.   


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4.2.2. 
Cohort 2: HBC (n=21-78) 
Cohort 2 will include patients with relapsed/refractory HBC harboring an IDH1 R132X 
mutation. HBC patients will be initially treated with single-agent FT-2102 (Cohort 2a). 
Cohort 2a will employ a Simon’s 2-stage design, in which 8 patients will be treated with single-
agent FT-2102 for 4 cycles (cycle=28 days) and assessed for efficacy and safety (Stage 1).  
If ≥1 clinical response is observed in Stage 1, then Stage 2 (n=15) will receive single-agent 
FT-2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination 
therapy may be examined (FT-2102 + PD-1 inhibitor) (Cohort 2b).  
Cohort 2b will employ a new Simon’s 2-stage design, whereby 13 patients will be treated in 
Stage 1 with combination therapy for 4 cycles (cycle=28 days) and assessed for efficacy and 
safety.  
If ≥4 clinical response is observed in Stage 1 of Cohort 2b, then Stage 2 (n=42) will initiate with 
combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any HBC patients enrolled in the Safety Lead-in Period will be considered part of Stage 1 
enrollment. 
4.2.3. 
Cohort 3: Chondrosarcoma (n=16-46) 
Cohort 3 will include patients with relapsed/refractory, locally advanced or metastatic 
chondrosarcoma harboring an IDH1 R132X mutation. Chondrosarcoma patients will be initially 
treated with single-agent FT-2102 (Cohort 3a). Cohort 3a will employ a Simon’s 2-stage design, 
in which 8 patients will be treated with single-agent FT-2102 for 4 cycles (cycle=28 days) and 
assessed for efficacy and safety (Stage 1).  
If ≥1 clinical response is observed in Stage 1, then Stage 2 (n=15) will initiate with single-agent 
FT-2102.   
If no clinical responses are observed in Stage 1 with single-agent FT-2102, then combination 
therapy may be examined (FT-2102 + 5-azacitidine) (Cohort 3b). Cohort 3b will employ the 
same Simon’s 2-stage design, enrolling 8 patients in Stage 1 and 15 evaluable patients in Stage 2 
(n=15) with combination therapy. 
If ≥1 clinical responses are observed in Stage 1 of Cohort 3b, then Stage 2 (n=15) will be 
initiated with combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any chondrosarcoma patients enrolled in the Safety Lead-in Period will be considered part 
of Stage 1 enrollment. 


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4.2.4. 
Cohort 4: Cholangiocarcinoma (n=21-77) 
Cohort 4 will include patients with advanced cholangiocarcinoma harboring an IDH1 R132X 
mutation. Cholangiocarcinoma patients will be initially treated with single-agent FT-2102 
(Cohort 4a). Cohort 4a will employ a Simon’s 2-stage design, in which 8 patients will be treated 
with single-agent FT-2102 for 4 cycles and assessed for efficacy and safety (Stage 1).  
If ≥2 clinical responses are observed in Stage 1, then Stage 2 (n=14) will initiate with single-
agent FT-2102.   
If <2 clinical responses are observed in Stage 1 with single-agent FT-2102, then combination 
therapy may be examined (FT-2102 + GemCis) (Cohort 4b).  
Cohort 4b will employ a Simon’s 2-stage design, whereby 13 patients will be treated in Stage 1 
with combination therapy for 4 cycles and assessed for efficacy and safety.  
If ≥4 clinical responses are observed in Stage 1 of Cohort 4b, then Stage 2 (n=42) will be 
initiated with combination therapy. 
During Stage 1 aggregate safety data will be monitored by the SRC. If unacceptable toxicity is 
observed in Stage 1, then the dose and schedule may be modified by the SRC. 
Note: any cholangiocarcinoma patients enrolled in the Safety Lead-in Period will be considered 
part of Stage 1 enrollment.  
4.2.5. 
Cohort 5a: Other Non-CNS Solid Tumors with IDH1 Mutations (n=6) 
Cohort 5a will include patients with relapsed or refractory non-central nervous system (CNS) 
solid tumors harboring an IDH1 R132X mutation. This cohort will only include treatment with 
single-agent FT-2102. Due to the diverse population, this is an exploratory cohort without 
pre-defined efficacy/futility determinations. Aggregate safety data will be monitored by the SRC 
and if unacceptable toxicity (a DLT) is observed in ≥2 of the first 6 patients, the cohort will be 
closed for additional enrollment.  
4.3. 
Monitoring of Adverse Events: 
Patients will be monitored continuously for toxicity while on study drug. AE severity will be 
assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events 
(NCI CTCAE) version 4.03. If a patient has an AE of particular severity or an AE assessed as at 
least possibly related to study drug, then dose modifications will be made according to the 
guidelines set forth in the study protocol. 
4.4. 
DLTs 
4.4.1. 
Single-Agent Safety Lead-in  
DLTs will be evaluated during the Safety Lead-in Period during the first treatment cycle 
(28 days) using the NCI CTCAE version 4.03. DLTs are any of the toxicities outlined in below 
unrelated to underlying disease and considered related to FT-2102.  


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Non-hematologic Toxicities: 
• ≥Grade 3 toxicity except: Grade 3 nausea, vomiting, diarrhea or rash lasting 
<72 hours (with optimal medical management)  
• Clinically relevant (i.e. requiring treatment or with clinical sequelae) ≥Grade 3 
non-hematologic laboratory finding 
Hematologic Toxicities: 
• ≥Grade 3 thrombocytopenia 
• Grade 4 neutropenia lasting for >7 days 
• ≥Grade 3 febrile neutropenia  
Drug relatedness will be Investigator -assessed. Grade 3 laboratory abnormalities recorded as an 
AE, but without clinical sequelae and not requiring treatment, are not considered DLTs. Disease 
progression is not considered an AE if assessed by the Investigator  to be unrelated to study 
agent. Any DLTs that occur after the Cycle 1 DLT review period will still be considered by the 
SRC in the evaluation of Stage 1 from the Simon’s 2-stage design and for the overall RP2D. 
4.4.2. 
Combination Therapy Safety Lead-in 
DLTs will also be evaluated during Stage 1 of any cohort examining combination therapy 
(Cohort 1b, Cohort 2b, Cohort 3b, and Cohort 4b) using a 3+3 design.  
DLTs will be assessed during the first full treatment cycle of both agents (28 days) using NCI 
CTCAE criteria version 4.03. Drug relatedness will be Investigator -assessed. Grade 3 laboratory 
abnormalities recorded as an AE, but without clinical sequelae and not requiring treatment, are 
not considered DLTs. Disease progression is not considered an AE if assessed by Investigator  to 
be within the expected tempo of that disease. 
Dose-limiting toxicities are any of the toxicities outlined below unrelated to underlying disease 
and considered related to FT-2102 and unrelated to the known toxicities of the combination 
agent(s).  
Non-hematologic Toxicities: 
• ≥Grade 3 toxicity except: Grade 3 nausea, vomiting, diarrhea, or rash lasting 
<72 hours (with optimal medical management)  
• Clinically relevant (i.e. requiring treatment or with clinical sequelae) ≥Grade 3 non-
hematologic laboratory finding  
Hematologic Toxicities: 
• Grade 4 thrombocytopenia 
• Grade 3 thrombocytopenia with grade 2 or greater bleeding  


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• Grade 4 neutropenia lasting for >7 days 
• Grade 4 febrile neutropenia  
Any DLTs that occur after the Cycle 1 review period will still be considered by the SRC in the 
evaluation of Stage 1 from the Simon’s 2-stage design and for the RP2D. Patients who 
experience a DLT may have the opportunity to continue treatment at a lower dose.  
4.5. 
Treatment Discontinuation 
Treatment discontinuation is defined as any patient who stops receiving study medication. A 
patient should be discontinued from study treatment if, in the opinion of the Investigator or 
Sponsor, it is medically necessary, or if it is the wish of the patient. 
All patients who discontinue study treatment should enter Safety Follow-up (see Section 6.5). 
Patients may be discontinued from treatment in case of any of the following reasons: 
• An AE that requires permanent discontinuation of study treatment 
• Disease progression with no evidence of clinical benefit as measured by the 
appropriate response criteria  
• Noncompliance to protocol  
• Investigator decision  
• Patient becomes pregnant 
• Patient death 
• Patient lost to follow-up  
• Termination of the study by the Sponsor 
• Voluntary withdrawal of consent by patient  
AEs leading to the discontinuation of study drug will be followed until resolution, resolution to 
baseline or until the event is considered stable or chronic. 
If a patient discontinues study treatment, then an End of Treatment (EoT) Visit should occur 
within 7 days after the last dose of study drug. Each EoT assessment need not be performed if 
the patient has had the identical assessment within the previous 2 weeks or previous 30 days for 
disease response assessments.  
All patients will have a Safety Follow-up visit approximately 28 (+7) days after the last dose of 
study drug. If possible, this visit should occur prior to the initiation of any subsequent anticancer 
therapy. At a minimum, this visit should include collection of AEs and concomitant 
medications/procedures.  
For combination cohorts, patients who discontinue FT-2102 are considered to have discontinued 
study treatment. Patients who discontinue azacitidine, nivolumab, or GemCis are allowed to 
continue FT-2102 until disease progression. 


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4.6. 
Study Withdrawal and Study Completion 
Patients may voluntarily withdraw from the study at any time for any reason without prejudice.  
Patients will be withdrawn from the study in case of any of the following reasons: 
• Patient lost to follow-up  
• Termination of the study by Sponsor 
• Voluntary withdrawal by patient 
If the patient withdraws consent from the overall study participation (and not just study 
treatment), no further evaluations should be performed, and no attempts should be made to 
collect additional data. 
A patient is considered to have completed the study if they receive at least one dose of study 
drug and they are followed for survival for 24 months or if they died during the treatment or 
survival follow up period.  For interim data analyses, patients will be classified as ongoing if 
they have not died, been lost to follow-up, or withdrawn. 


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5. 
STUDY POPULATION 
This study will enroll up to approximately 200 patients across 4 disease-specific cohorts and 
1 exploratory cohort in non-CNS solid tumors. 
The study will include a Safety Lead-in Period, which will enroll approximately 6 patients with 
histologically or cytologically-confirmed IDH1 R132X gene-mutated advanced solid tumors and 
approximately 6 patients with histologically or cytologically-confirmed IDH1 R132X 
gene-mutated advanced gliomas that have recurred or progressed following standard therapy. 
Additional patients may be enrolled if different doses or an altered dosing schedule are explored. 
Patients enrolled during the Safety Lead-in Period who meet the criteria for enrollment into 1 of 
the 4 disease-specific cohorts outlined below will be counted as part of the Stage 1 evaluation for 
those disease-specific cohorts at the same dose.  
Cohort 1 will include approximately 16-46 evaluable patients with relapsed or refractory glioma 
(per World Health Organization [WHO] criteria 2016) with confirmed IDH1 mutation.  
Cohort 2 will include approximately 21-78 evaluable patients with relapsed or refractory 
hepatobiliary tumors with confirmed IDH1 mutation previously treated with an approved therapy 
for HBC. 
Cohort 3 will include approximately 16-46 evaluable patients with recurrent, refractory or either 
locally advanced or metastatic chondrosarcoma with confirmed IDH1 mutation not amenable to 
complete surgical excision. 
Cohort 4 will include approximately 21-77 evaluable patients with advanced, nonresectable or 
metastatic cholangiocarcinoma with confirmed IDH1 mutation not eligible for curative resection 
or transplantation. 
Cohort 5 will include up to 6 patients with relapsed or refractory other solid tumors with 
confirmed IDH1 mutation. 
5.1. 
Inclusion Criteria 
All patients must meet the following criteria for inclusion: 
1. ≥18 years of age 
2. Life expectancy of ≥4 months 
3. Able to provide tumor tissue sample (archival) 
4. Disease, defined as:  
Disease-specific Cohorts 
• Glioma (Cohort 1) 
- 
Histologically or cytologically confirmed IDH1 gene-mutated advanced 
glioma that has recurred or progressed following standard therapy, or that has 
not responded to standard therapy with measurable disease, defined as 
bidimensionally lesions, by T2/FLAIR, with clearly defined margins by CT or 
MRI scan, with a minimum size of both perpendicular measurements greater 
than or equal to 10 mm. Axial FLAIR (canthomeatal alignment): 3–5 mm 


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sections, 1 mm interslice gaps, slice registration preserved as much as possible 
between sequential studies 
- 
Glioblastoma multiforme with confirmed IDH1 gene-mutated disease with 
first or second recurrence with measurable disease, defined as bidimensionally 
lesions (contrast enhancing) with clearly defined margins by CT or MRI scan, 
with a minimum size of both perpendicular measurements greater than or 
equal to 10 mm and visible on 2 axial slices which are at least 5mm apart with 
0 mm skip. 
• HBC (Cohort 2) 
- 
Relapsed/refractory or intolerant to approved standard-of-care therapy 
(included: hepatocellular carcinoma, bile duct carcinoma, intrahepatic 
cholangiocarcinoma or other hepatobiliary carcinomas ) 
- 
Histologically or cytologically confirmed IDH1 gene-mutated with 
measurable disease per Response Evaluation Criteria in Solid Tumors 
(RECIST) 1.1 criteria 
- 
Child-Pugh Class A (Appendix 4) 
- 
Single Agent FT-2102: prior exposure to nivolumab is permitted 
- 
Combination Cohort 2b: patients may not have had prior exposure to 
nivolumab  
• Chondrosarcoma (Cohort 3) 
- 
Relapsed or refractory and either locally advanced or metastatic and not 
amenable to complete surgical excision 
- 
Histologically or cytologically confirmed IDH1 gene-mutated with 
measurable disease per RECIST 1.1 criteria 
• IHCC (Cohort 4) 
- 
Advanced nonresectable or metastatic cholangiocarcinoma not eligible for 
curative resection or transplantation.  
- 
Phase 1b/Safety Lead-in of Phase 2: relapsed or refractory disease 
- 
Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 
cycle of GemCis therapy 
- 
Histologically or cytologically confirmed IDH1 gene-mutated with 
measurable disease per RECIST 1.1 criteria 
• Other tumors (non-CNS) (Cohort 5) 
- 
Relapsed or refractory to standard-of-care therapy with no other available 
therapeutic options 
- 
Histologically or cytologically confirmed IDH1 gene-mutated with 
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5. Recovered to ≤Grade 2 or baseline toxicity (except alopecia) from prior therapy  
(per NCI CTCAE v 4.03)  
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2  
7. Adequate bone marrow function 
a. Absolute neutrophil count (ANC) ≥1.5 ×109/L without any growth factors in prior 7 
days  
b. Hemoglobin ≥8.0 g/dL (with or without transfusion support) 
Platelet count ≥75 ×109/L (with or without transfusion support); Cohort 4b 
(GemCis combination): platelet count ≥100 ×109/L (with or without transfusion 
support) 
8. Adequate hepatic function  
a. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine 
aminotransferase (ALT) (serum glutamic pyruvate transaminase ) ≤2.5 × institutional 
upper limit of normal (ULN). For patients with suspected malignancy related 
elevations, <5 × ULN. 
b. Total bilirubin ≤1.5 × ULN. For patients with suspected malignancy-related elevation 
<3 × institutional ULN. Patients with Gilbert Syndrome <3 × ULN. 
9. Adequate renal function 
a. Creatinine clearance per Cockcroft-Gault equation of ≥60 mL/min  
10. For women of childbearing potential (WCBP): negative serum β-human chorionic 
gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP 
defined as a sexually mature woman who has not undergone surgical sterilization or who 
has not been naturally post-menopausal for at least 12 consecutive months for women 
>55 years of age) 
11. Willingness of male and female patients who are not surgically sterile or postmenopausal 
to use medically acceptable methods of birth control for the duration of the study 
treatment, including a period of time after study treatment completed:  
o FT-2102 only: 90 days 
o Nivolumab (female): 150 days 
o Nivolumab (male): 210 days 
o Azacitidine: 180 days 
o Gemcitabine/Cisplatin: 180 days  
Sexually active women using oral contraceptive pills, should also use barrier 
contraception. Males must agree not to donate sperm while participating in the study and 
for 90 days after the last dose of the study drug. For males receiving cisplatin, they must 
agree not to donate sperm while participating in the study and for 2 years following 
cisplatin.   
12. Ability to adhere to the study visit schedule and all protocol requirements  


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13. Signed and dated IRB/independent ethics committee (IEC)-approved informed consent 
form before any screening procedures are performed 
5.2. 
Exclusion Criteria 
Patients are to be excluded from the study if they meet any of the following criteria: 
1. Previous solid organ or hematopoietic cell transplant  
2. Less than the minimum time has elapsed from prior anticancer treatment to first dose of 
study treatment as follows:  
a. Small molecule, antibody, or other anticancer therapeutic: 21 days (or 5 half-lives), 
whichever is shorter. Nitrosoureas or mitomycin C: 6 weeks.  For patients enrolling in 
the Phase 2 (beyond Safety Lead-in with IHCC): 14 days from GemCis therapy.    
b. Prior radiation therapy (including radiofrequency ablation): 4 weeks  
c. Prior stereotactic body radiation therapy: 2 weeks  
d. Prior chemoembolization or radioembolization:  4 weeks  
3. No previous treatment with an IDH1 inhibitor (single agent FT-2102 cohorts only)  
4. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina 
pectoris; previous history of myocardial infarction within one year prior to study entry, 
uncontrolled hypertension, or uncontrolled arrhythmias 
5. History of QT prolongation or baseline QT interval corrected with Fridericia’s method 
(QTcF) >450 ms (average of triplicate readings) 
NOTE: criterion does not apply to patients with a right or left bundle-branch block, a 
cardiology consult is recommended to assure that QTcF is not prolonged. 
6. Concomitant medication(s) associated with QTc interval prolongation or Torsades de 
Pointes (TdP) initiated <4 weeks before first dose of study drug (see Appendix 3) 
(medications used as needed [PRN] [e.g., Zofran] are exempt).  
7. Pregnant or nursing women or WCBP not using adequate contraception; male patients 
not using adequate contraception  
8. Other malignancy within the last 5 years except: adequately treated non-melanoma skin 
cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ, Stage 1, 
Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without 
bone marrow involvement) curatively treated with no evidence of disease for ≥5 years 
9. Major surgery within 4 weeks of starting study treatment or not recovered from any 
effects of prior major surgery (uncomplicated central line placement or fine needle 
aspirate are not considered major surgery) 
10. Receipt of a live vaccine (including yellow fever vaccine) within 30 days of first day of 
study treatment 
11. Patients receiving >6 mg/day of dexamethasone or equivalent 
12. Patients with gastrointestinal disorders likely to interfere with absorption of the study 
medication  


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13. Known human immunodeficiency virus (HIV) positivity 
14. Active infection with hepatitis B or C virus (Hep B or C viral load >100 international 
units/milliliter or local institutional equivalent) 
15. Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, 
unstable pulmonary condition including pneumonitis and/or interstitial lung disease, 
uncontrolled diabetes) or any important medical or psychiatric illness or abnormal 
laboratory finding that would, in the Investigator ’s judgment, increase the risk to the 
patient associated with his or her participation in the study. This includes any condition 
that would be considered a contraindication per local prescribing information to receipt of 
either azacitidine, nivolumab, gemcitabine or cisplatin based on cohort assigned 
(combination patients only).   
16. PD-1 combination only: 
a. Patients with active autoimmune disease  
Note: patients with well-controlled diabetes or hypothyroidism are eligible 
b. Patients with active infections, gastrointestinal tract bleeding, enterocleisis (colon 
obstruction) and severe colitis are excluded   
Note: Eligibility criteria waivers will not be granted. 
 


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6. 
STUDY PROCEDURES AND ASSESSMENTS 
Time points for assessments to be collected throughout the study can be found in the following 
tables: 
Screening Assessments Checklist 
Table 1 
Schedule of Assessments  
Single-Agent FT-2102 (Safety Lead-in, Cohorts 1a, 2a, 3a, 4a, and 5) 
Table 2 
Schedule of Assessments  
FT-2102 + 5-Azacitidine Cohort 1b [Glioma]  
and Cohort 3b [Chondrosarcoma]) 
Table 3 
Schedule of Assessments  
FT-2102 + PD-1 Inhibitor (Cohort 2b [HBC]) 
Table 4 
Schedule of Assessments  
FT-2102 + Chemotherapy (GemCis) Cohort 4b (IHCC) 
Table 5 
Schedule of PK and Electrocardiogram (ECG) Assessments  
(Safety Lead-in and Stage 1 of each Cohort) 
Table 6  
Schedule of PK and ECG Assessments  
(Stage 2 of Each Cohort: Single-Agent and Combination) 
Table 7 
Schedule of Efficacy and Biomarker Assessments (by Cohort) 
Table 8 
A brief description of each assessment can be found below.  
6.1. 
Screening Assessments 
Patients who fail screening criteria may be rescreened later within the initial screening period to 
confirm eligibility. If rescreening occurs after the initial screening period, sites should contact 
the study Medical Monitor for approval. 
6.1.1. 
Informed Consent 
Patients potentially eligible for participation must sign an informed consent form (ICF) prior to 
initiating any study-specific procedures. Standard of care assessments that fulfill study eligibility 
requirements may be performed prior to patient signing the ICF. 
6.1.2. 
Inclusion and Exclusion Criteria 
Inclusion and exclusion criteria (Section 5.1 and Section 5.2, respectively) will be reviewed for 
each potential patient and documented in the patient medical record and electronic case report 
form (eCRF). During the screening period a patient number will be assigned. 


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6.1.3. 
Medical History, Demographics, and Cancer History 
Each patient’s complete medical history will be obtained, including demographics, cancer 
history, and documentation of all previous treatments and treatment results (ie, best response to 
previous disease-specific treatments), prior procedures, current medications, and all medications 
used within 30 days prior to Screening.  
6.1.4. 
Prior/Concomitant Medications and Procedures 
At Screening, concomitant/previous medications and procedures will be assessed including all 
medications/procedures that have occurred within the previous 30 days. 
6.1.5. 
Physical Exam 
A full physical exam (PE) will be performed at Screening and will include vital signs 
(temperature, blood pressure [sitting for 5 minutes], pulse rate, and respiratory rate), height, and 
weight. If vital signs need to be repeated during a single visit, assessments should be conducted 
approximately 5 minutes apart. All other physical exams performed on study should be 
symptom-led assessments.  
Following Screening, physical examination will be symptom-directed, and will include 
collection of vital signs. Results from the symptom-directed physical exams will be used for 
assessment of disease response. Any new clinically significant abnormality from baseline or 
significant worsening of pre-existing abnormality should be recorded as an AE. 
6.1.6. 
Eastern Cooperative Oncology Group Performance Status  
ECOG Performance Status will be assessed at Screening. If the ECOG Performance Status 
assessed at Screening is performed within 7 days of Cycle 1 Day 1, the Screening assessment can 
be used and does not need to be repeated at Cycle 1 Day 1 (predose). Refer to Appendix 1 for a 
sample of the ECOG assessment. 
6.1.7. 
Electrocardiogram  
ECGs will be conducted following an approximate 10-minute rest period and obtained in 
triplicate within approximately a 5-minute time period at the time points outlined in Table 1, 
Table 6 and Table 7.   
6.1.8. 
Clinical Laboratory Tests 
The following laboratory parameters will be measured at Screening (Table 1) and throughout the 
treatment period (Table 2, Table 3, Table 4, and Table 5), and will be analyzed locally: 
• A serum β-hCG pregnancy test should be collected at Screening, within 7 days prior 
to the first dose for all women of child bearing potential. Subsequent pregnancy tests 
during the treatment period may be either urine or serum. 
• Hematology laboratory parameters include hemoglobin, hematocrit, white blood cell 
(WBC) count with differential to include an ANC, and platelet count.  
• Blood chemistry laboratory parameters include: albumin, total protein, sodium, 
potassium, calcium, phosphorous, chloride, bicarbonate (or carbon dioxide), blood 


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urea nitrogen (BUN) or urea, creatinine, magnesium, and glucose. Liver function tests 
include serum ALT, serum AST, total and direct bilirubin, and alkaline phosphatase.  
• Weekly liver function testing is required through Cycle 2. 
• Patients with hepatobiliary and cholangiocarcinoma only: alpha feto protein (AFP), 
carcinoembryonic antigen (CEA), and CA 19-9 (pre-dose and on treatment per 
Table 8).  
• PT/aPTT will be assessed in all patients at C1D1 only. 
Unscheduled assessments should be performed as clinically indicated and recorded in the eCRF. 
Clinically significant laboratory findings at Screening should be recorded as medical history.   
For Cycle 1 Day 1 (predose), hematology and blood chemistry (including liver function tests) 
evaluations may be performed within 7 days prior to study treatment, and these results can be 
used in place of the Cycle 1 Day 1 results. 
Clinically significant laboratory findings, including but not limited to those findings resulting in 
a drug interruption/hold/reduction/discontinuation or medical intervention, should be reported as 
AEs (see Section 8.1.1 for definition of an AE).  
6.1.9. 
Additional Screening Laboratory Measurements 
At Screening, the following assessments will be performed to determine eligibility: 
Hepatitis: All patients will be tested for anti-hepatitis C antibody (anti-HCV) and hepatitis B 
surface antigen (HBsAg) at Screening. Reflex Hepatitis C RNA if antibody test is positive, then 
only patients with hepatitis C RNA <615 IU/L or 100 copies/ml per National Genetics Institute 
assay or local institutional standard will be eligible.    
6.1.10. 
Urinalysis 
Complete urinalysis with qualitative analysis for protein (dipstick) should be performed at 
Screening as outlined in Table 1 and will be analyzed locally.  
6.1.11. 
Tumor Evaluation 
Quantification of baseline disease burden should be performed at Screening and as outlined in 
the Schedule of Assessments as applicable for disease type under study. The modality chosen to 
evaluate each individual patient should be the same throughout the duration of the study. 
Please see Section 6.3 for more information on disease-specific tests to be performed at 
Screening and on study. 
 
6.1.12. 
Tumor Biopsy  
Most recent tumor sample, in the form of formalin-fixed, paraffin-embedded (FFPE) block or cut 
slides and accompanying pathology report for all patients will be collected as described in the 
Lab Manual. Optional fresh tumor biopsies at times of disease assessment or at relapse will be 
requested as described in Table 2, Table 3, Table 4, and Table 5. 


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6.1.13. 
Adverse Events 
For all patients, non-serious AEs should be monitored from the time of the first dose of study 
drug through the post-treatment follow-up visit or 28 days after the last dose of FT-2102, 
whichever is later. After the patient is enrolled, all AEs will be captured on the eCRF. 
All SAEs for all patients will be reported from the time of the signing of the ICF until the post-
treatment follow-up visit or 28 days after the last dose of FT-2102, whichever is later, or until the 
patient has been deemed to be a screen failure. At any time after completion of the AE reporting 
period (ie, 28 days post last dose of FT-2102), if an Investigator becomes aware of an SAE that 
the Investigator considers to be related to any study drug, the event must be reported.  
All Adverse Events of Special Interest (AESI), as defined in Section 8.2.3, will be reported from 
first dose of study drug through 28 days after the last dose of FT-2102. 
See Section 8.2 for a full description of the collection and reporting of AEs during this study. 
6.2. 
Safety Assessments 
6.2.1. 
Concomitant Medication and Therapies 
At every clinic visit, assessment of any change in concomitant medications or procedures since 
the last visit will occur. Dose, reason, start and stop date of corticosteroid use in patients with 
CNS tumors should be specified in the eCRF. 
6.2.2. 
Adverse Events 
See Section 8.2 for a full description of the collection and reporting of AEs during this study. 
6.3. 
Response Assessment Procedures 
For all parts of the study, response and progression will be determined by Investigator  
assessment using the appropriate response criteria per disease at the time points shown in  
Table 8. Additional imaging and response evaluation based upon clinical evidence of progression 
is at the discretion of the Investigator.  
These evaluations will be conducted until the patient experiences progressive disease or 
discontinues the study. See Section 6.3.1 for more information regarding the disease-specific 
response procedures and response criteria. 
6.3.1. 
Response Evaluation Criteria 
Please see Appendix 2 for more details. 
6.3.1.1. 
Glioma 
For patients with low grade glioma the LGG-RANO criteria will be used for disease evaluation 
with confirmation of a sustained response for a minimum of 4 weeks. For patients with high 
grade glioma the RANO, 2011 criteria will be used for disease evaluation with confirmation of a 
sustained response for a minimum of 4 weeks.   


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6.3.1.2. 
Chondrosarcoma 
Response will be determined by RECIST 1.1 (Eisenhauer et al, 2009) with confirmation of a 
sustained response for a minimum of 4 weeks.  
6.3.1.3. 
HBC 
Response will be determined by RECIST 1.1 (Eisenhauer et al, 2009) with confirmation of a 
sustained response for a minimum of 4 weeks. 
6.3.1.4. 
Cholangiocarcinoma  
Response will be determined by RECIST 1.1 (Eisenhauer et al, 2009) with confirmation of a 
sustained response for a minimum of 4 weeks.  
6.3.1.5. 
Other Solid Tumors 
Response for patients with other solid tumors will be assessed with their appropriate response 
criteria, most often RECIST 1.1 (Eisenhauer et al, 2009). If a patient enrolls into this cohort with 
lymphoma, they will be assessed via the Cheson criteria (Cheson, 2014). 
  
6.4. 
Other Study Procedures 
6.4.1. 
Study Drug Administration 
Detailed instructions on administration of FT-2102 can be found in Section 7.1. 
6.4.2. 
Pharmacokinetic Sampling 
PK sample collection time points are shown in Table 6 and Table 7. Plasma samples will be 
analyzed for FT-2102 concentrations using a validated high-performance liquid chromatography-
tandem mass spectrometry (LC/MS/MS) method.  
The date and time of each sample collection and date and time of the prior study drug dose must 
be recorded for all collected samples. When FT-2102 is given with another combination agent 
(nivolumab, azacitidine, gemcitabine/cisplatin) time zero is when the FT-2102 is administered. 
An additional PK sample, beyond those listed in Table 6 and Table 7, may be requested (when 
feasible) at the time of any unusual safety event (i.e., an AE different in type and severity from 
that which is expected in the setting of FT-2102 use). 
Refer to the 2102-ONC-102 Laboratory Manual for details on processing, storage, and shipment 
of PK samples. 
6.4.3. 
Pharmacodynamic Sampling 
Refer to the 2102-ONC-102 Laboratory Manual for PD sample handling procedures and 
shipping requirements. 


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6.4.4. 
Biomarker Assessments 
Blood and CSF, and urine (glioma only) will be collected for biomarkers as described in Table 2, 
Table 3, Table 4, Table 5, Table 6 and Table 7. CSF to be collected per investigator’s discretion 
and if clinically necessary.  
6.4.5. 
Tumor Biopsy 
Optional fresh tumor tissue biopsies will be performed at the time points outlined in Table 2, 
Table 3, Table 4, and Table 5.  
See the 2102-ONC-102 Laboratory Manual for instructions on fixation and processing of tumor 
tissue. 
6.4.6. 
Lumbar Puncture 
For patients undergoing a lumbar puncture for clinical care, a sample of CSF is being requested. 
This is an optional procedure and only for those patients undergoing the procedure as part of 
clinical care.  
See the 2102-ONC-102 Laboratory Manual for instructions on volume and tubes. 
6.4.7. 
Quality of Life (EQSD) 
The EQ5D Quality of Life Assessment will be performed as outlined in Table 2, Table 3, 
Table 4, and Table 5. 
6.4.8. 
Magnetic Resonance Spectroscopy for 2-HG  
Imaging will be collected at selected US sites for patients with glioma to evaluate 2-HG levels 
via magnetic resonance spectroscopy. Details will be provided in an imaging manual provided to 
sites. Data will be collected at baseline and at time of disease assessments.   
6.4.9. 
Additional Exploratory biomarkers 
Samples collected during the study will be banked for up to 25 years. Any material left over will 
be used to conduct research related to FT-2102. 
6.5. 
Safety Follow-up Visit 
All patients will have a Post-Treatment Follow-up visit 28 days after discontinuation of study 
treatment. If possible, this visit should occur prior to the initiation of any subsequent anticancer 
therapy. Patients continuing to experience toxicity at this point following the discontinuation of 
treatment will continue to be followed at least every 4 weeks until resolution or determination in 
the clinical judgement of the Investigator that no further improvement is expected. 
6.6. 
Safety Follow-up 
Survival follow-up assessments will occur every 3 months following documented disease 
progression or start of a new cancer therapy until the last patient is off treatment. These 
assessments may be conducted by telephone interview. Information on initiation of other 
anticancer therapy (including start date, therapy type/name, and response on treatment) will be 
collected. Additional survival follow-up calls may occur periodically if needed for data analysis. 


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6.7. 
Concomitant Medications 
6.7.1. 
Prohibited: Other Anticancer Therapy or Investigational Agents 
During the study treatment period, patients are not to receive any additional anticancer therapy or 
other investigational agents.  
6.7.2. 
Other Concomitant Therapies 
Any other medication which is considered necessary for the patient’s welfare, including 
antimicrobial prophylaxis, may be given at the discretion of the Investigator.  
6.7.2.1. 
Concomitant Medications to Use with Caution  
Co-administration of FT-2102 with strong CYP3A4 inducers significantly reduces FT-2102 
systemic exposure, therefore co-administration is not recommended and investigators should 
consider alternative medications.  
FT-2102 exhibits CYP3A4 induction potential in vitro and may impact the PK of co-
administered sensitive CYP3A4 substrates through increased clearance. Medications that are 
sensitive substrates of CYP3A4 should not be used while taking FT-2102.  
If the patient’s clinical condition requires a medication of concern, the clinical condition should 
be reviewed with the study Medical Monitor. Refer to Appendix 5 for a list of strong CYP3A4 
inducers and sensitive substrates. 
6.7.2.2. 
Concomitant Medications Prohibited 
During study treatment and for three months following FT-2102, receipt of live vaccines is 
prohibited (including the yellow fever vaccine). Annual influenza vaccine is permitted. 
Concomitant medication(s) associated with known risk of Torsades de Pointes (TdP) are 
prohibited (see Appendix 3). Medications used as needed [PRN] [e.g., Zofran] are permitted.  
Concomitant medications that would be contraindicated with any of the combination agents are 
prohibited during the trial, based on approved prescribing information. For example, highly 
nephrotoxic agents with cisplatin.   
6.8. 
Precautions 
6.8.1. 
Differentiation Syndrome 
Differentiation syndrome has been observed in patients participating in the hematologic 
malignancy protocol ongoing study and has also been reported in patients with AML/MDS 
receiving another therapy targeting the IDH1-R132 mutation (Birendra et al, 2016) or receiving 
azacitidine (Laufer et al, 2015). It would be unlikely to occur in patients with solid tumors. If 
there are unexplained fevers, weight gain, respiratory distress, interstitial pulmonary infiltrates, 
and pleural or pericardial effusion, with or without hyperleukocytosis (Frankel et al, 1992), 
FT-2102 should be held and consideration given to prompt initiation of dexamethasone 10 mg IV 
every 12 hours. Discussion with the Medical Monitor would be required to reinitiate FT-2102.  




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d. If after a minimum of 28 days of 150 mg once daily, the AST, ALT and total bilirubin 
have not elevated to Grade 2 or greater and no other symptoms have been reported, then 
FT-2102 may be re-escalated to the starting dose, if applicable.  
e. Frequent monitoring (at least twice per week) is required upon re-escalation, if 
applicable, and may be decreased after patient has been on the escalated dose for at least 
28 days without an increase in the AST, ALT and total bilirubin. 
Patients on active treatment with FT-2102 should be informed to promptly notify study staff if 
they develop any clinical symptoms of jaundice and to avoid personal habits (excessive ethanol 
consumption, over-the-counter hepatic injurious medications, herbal medications [e.g., 
cannabidiol or comparable products]) that may cause additional risk of hepatic injury. 
6.8.3. 
Phototoxicity 
A phototoxic potential was demonstrated for FT-2102 in a standard in vitro assay system. Until 
the photosafety of FT-2102 has been adequately demonstrated in vivo, photosafety risk in the 
clinical setting will be managed by the use of light-protective measures. Patients should be 
instructed to avoid extensive sun exposure, phototherapy, or use of a tanning salon within a 
prudent amount of time prior to and following trial participation. 
6.8.4. 
Childbearing Potential 
For all patients of childbearing potential, all methods of contraception, including abstinence, 
must be in use from the time of consent through the final study visit, and for 90 days after the 
last dose of study drug. Patients who are not sexually active during the Screening Period must 
agree to the contraceptive requirements if they become sexually active with a partner of the 
opposite sex during the study and for the following time periods after study treatment completed: 
- 
FT-2102 only: 90 days 
- 
Nivolumab (female): 150 days 
- 
Nivolumab (male): 210 days 
- 
Azacitidine: 180 days 
- 
Gemcitabine/Cisplatin: 180 days  
Unique situations that may not fall within these specifications may be discussed with the Forma 
Therapeutics Medical Monitor on an individual basis.  Investigators are advised to discuss with 
each patient their options regarding cryopreservation of sperm or ova prior to initiation of 
therapy per local institutional standard as the treatment may increase the risks of infertility.  
Female patients will be considered of childbearing potential after the onset of their first 
menstrual period. Female patients who are documented as being of nonchildbearing potential 
(postmenopausal or having undergone surgical sterilization) are exempt from this requirement. 
Female patients will be considered postmenopausal if they have had 12 months of consecutive 
spontaneous amenorrhea or less than 12 months of consecutive spontaneous amenorrhea and a 
serum FSH level >40 mIU/mL at Screening. Female patients will be considered surgically sterile 
if they are post-hysterectomy, 6 months post-surgical bilateral oophorectomy, or 6 months post-
tubal ligation. The effects of FT-2102 on conception, pregnancy, and lactation are unknown. 


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6.8.4.1. 
Contraception Guidelines 
Acceptable methods of contraception under this protocol are listed below. Periodic abstinence 
(calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides 
only, and lactational amenorrhoea method are not acceptable methods of contraception.  
Male patients who can father a child must agree to use 1 highly effective method of 
contraception, which includes:  
• Abstinence: abstinence can be used, when in line with the preferred and usual 
lifestyle of the patient.  
• If a male patient confirms that his female partner(s) is not of childbearing potential 
(i.e., postmenopausal or post-surgical sterilization, as defined above) or is using a 
highly effective method of contraception, this is acceptable as the only means of 
contraception.  
Examples of highly effective methods of contraception for male patients’ female partner(s) 
include:  
• Hormonal contraceptives  
• Intrauterine device (IUD)  
Alternatively, two effective methods of contraception can be utilized and may include:  
• The use of a male condom with spermicide with a female occlusive cap (such as a 
diaphragm or cervical cap) with spermicide  
Male patients with documented infertility or surgical sterilization (performed at least six months 
before the first dose of study drug) are exempt from the contraception requirement. Infertility 
may be documented through examination of a semen specimen or by demonstration of the 
absence of the vas deferens on ultrasound before the first dose of study drug (Day 1).  
Female patients who are considered of childbearing potential must agree to use a highly 
effective method of contraception, which may include:  
• IUD  
• Abstinence: abstinence can be used, when in line with the preferred and usual 
lifestyle of the patient.  
• If a female patient confirms that her male partner(s) has been confirmed to be 
clinically sterile, this method is acceptable as the only means of contraception.  
Alternatively, effective double-barrier contraception may be used, to include:  
• The use of a male condom with spermicide with a female occlusive cap with 
spermicide (such as a diaphragm or cervical cap)  
Hormonal contraceptives are not considered an effective method of birth control for female 
patients participating in this study. Male condoms with female condoms should not be used 
together.  


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6.8.4.2. 
Guidance Against Donating Sperm or Ova 
Male patients are prohibited from donating sperm and female patients of childbearing potential 
are prohibited from donating ova during the study and for 90 days after the final dose of study 
drug. For males receiving cisplatin, they must agree not to donate sperm while participating in 
the study and for 2 years following cisplatin.   
 




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Patients will be supplied with the correct number of capsules for the number of doses to be taken 
prior to the next scheduled visit. 
7.1.3. 
Storage 
FT-2102 capsules shall be stored according to storage conditions provided on the drug product 
label. 
7.2. 
5-azacitidine 
Azacitidine is supplied as a lyophilized powder in 100 mg single-use vials containing no 
preservative and is packaged in cartons of one vial. 
7.2.1. 
Dosage 
The dose of 5-azacitidine will 75 mg/m2 daily for on Days 1-7 of each cycle (VIDAZA US 
Prescribing Information). Patient should be premedicated for nausea and vomiting per local 
institutional standard of care. Cycles should be repeated every 4 weeks (28 days).  Treatment 
may be continued as long as the patient continues to derive clinical benefit. If the patient 
experiences unacceptable intolerance to azacitidine, patients can continue with FT-2102 as a 
single agent following discussion with Medical Monitor. 
7.2.2. 
Administration 
Azacitidine will be administered intravenously (IV) daily for 7 days in combination with 
FT-2102 to patients with glioma in Cohort 1 and patients with chondrosarcoma in Cohort 3 in 
combination with FT-2102. If an Investigator  or patient wishes to use subcutaneously dosing, 
that is permitted (same dose and same schedule). The FT-2102 is administered prior to the 
azacitidine. Azacitidine when given as an IV infusion should be completed within one hour of 
reconstitution per local standard of care.  
7.2.3. 
Storage 
Unreconstituted vials of azacitidine must be stored according to storage conditions provided in 
the VIDAZA® package insert. Please see Pharmacy manual for storage, preparation and handling 
Azacitidine should be reconstituted aseptically with 4 mL of sterile water for injection. The 
resulting suspension will contain azacitidine 25 mg/mL (10 mg/ml for IV preparation is 
acceptable). Azacitidine will be administered via subcutaneous injection or intravenous infusion 
at approximately the same time on scheduled dose days, in accordance with the azacitidine 
dosing instructions (VIDAZA US Prescribing Information). Patients may have up to a 48-hour 
drug holiday for weekends during the 7 days of azacitidine.  
7.3. 
PD-1 Inhibitor (Nivolumab) 
Nivolumab is supplied as a solution: 40 mg/4 mL, 100 mg/10 mL, or 240 mg/24 mL solution in a 
single-dose vial depending on applicable regional approvals  


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7.3.1. 
Dosage 
Nivolumab will be administered intravenously (IV) every 2 weeks (day 1 and 15 +/- 2 days). The 
recommended dose of nivolumab is 240 mg administered as an intravenous infusion over 
60 minutes or local institutional standard.  
If the patient experiences unacceptable intolerance to nivolumab, patients can continue with FT-
2102 as a single agent following discussion with Medical Monitor. 
7.3.2. 
Administration 
Nivolumab will be administered via an IV infusion every 2 weeks, in combination with FT-2102 
in patients with hepatobiliary cancers in Cohort 2.  The FT-2102 is administered prior to the 
nivolumab. 
7.3.3. 
Storage 
Un-reconstituted vials of nivolumab must be stored according to storage conditions provided in 
the OPDIVO® package insert. Please see Pharmacy manual for storage, preparation and 
handling.  
7.4. 
Gemcitabine/Cisplatin (GemCis)  
7.4.1. 
Dosage 
Patients will receive GemCis (cisplatin 25 mg/m2 followed by gemcitabine 1000 mg/m2) IV on 
Day 1 and Day 8 of every 28-day (±7 days) cycle for up to 6 cycles. FT-2102 will be given 
concurrently days 1-28 of each cycle. Following completion of 6 cycles or intolerance to 
GemCis, patients can continue with FT-2102 as a single agent.  FT-2102 is administered prior to 
cisplatin/gemcitabine. Cisplatin should be given as an 1 hour infusion with appropriate hydration 
(e.g., 1 liter of 0.9% saline including cisplatin, 20 mmol of potassium chloride, and 8 mmol of 
magnesium sulfate over 1 hour followed by 500 ml of 0.9% saline over 30 minutes) followed by 
administration of gemcitabine as a 30-minute infusion.  Pre-medications (anti-emetics and pre-
hydration) per local standard of care. Total duration of all medications and infusions would be 2-
3 hours. 
7.4.2. 
Administration 
GemCis will be administered in combination with FT-2102 in patients with IHCC in Cohort 4. 
7.4.3. 
Storage 
Gemcitabine is provided in 10-mL or 50-mL size sterile single-use vials containing 200 mg or 
1000 mg, respectively, of white to off-white, lyophilized powder. Please see Pharmacy manual 
for storage, preparation and handling.  
Cisplatin Injection (1 mg/mL) is supplied either as 50 mg per 50 mL (50 mL fill in 100 mL vial) 
or 100 mg per 100 mL (100 mL fill in 100 mL vial). Please see Pharmacy manual for storage, 
preparation and handling. .  


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7.5. 
Dose Holds, Modifications, and Discontinuations 
Patients will be monitored continuously for toxicity while on study treatment. Toxicity severity 
will be assessed using the NCI CTCAE v. 4.03. If a patient has an AE related to FT-2102, dose 
interruptions/holds with possible modifications may occur as described below. 
7.5.1. 
Dose Holds and Modifications  
Dose modifications apply only to patients beyond a DLT period, either single-agent or in 
combination. If patients have a DLT, study agent should be stopped.  
For patients beyond a DLT period: a dose may be withheld up to 28 days for toxicity. Doses 
withheld for > 28 days may result in discontinuation from the study, unless approved by the 
medical monitor. For azacitidine, nivolumab, gemcitabine and cisplatin, all dose modifications 
outside of DLT periods are at the discretion of the treating investigator and the following are 
provided as guidelines.  
7.5.1.1. 
FT-2102 
Dose modifications are required if any of the following toxicities occur and are judged by the 
Investigator  as related to study drug (i.e., assessed as unrelated to disease, intercurrent illness, or 
concomitant medications): 
If in the opinion of the Investigator, the patient experiences any of the study drug-related 
toxicities outlined in Table 12, FT-2102 dose(s) will be held until recovery of the toxicity to 
≤Grade 1. Dose modification guidelines for liver function test (LFT) abnormalities are presented 
in Table 13. 
 
 
 




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Escalation of FT-2102 following any dose reduction: 
Patients who have a dose reduction due to a toxicity may be eligible for a dose increase back to 
the dose level prior to the reduction (ie, the starting dose) if the patient has tolerated the reduced 
dose for a minimum of 28 days without any grade 2 or greater toxicities. 
Dose confirmation phases:  
During Cycle 1 in the dose confirmation stages of the study (single- agent and combination), 
patients who do not receive their scheduled dose due to drug toxicity (dose hold) will have that 
counted towards the criteria for a DLT. Dose-reductions will not occur in Cycle 1.  
7.5.1.2. 
5-Azacitidine 
Dosage Adjustment Based on Hematology Laboratory Values 
For subsequent doses, if the ANC has not recovered to >1x 109/L AND platelet >50 x 109/L 
within 14 days of completion of 5-azacitidine, subsequent courses should be modified per table 
below: 
Counts 
% Dose in the Next 
Course 
ANC ×109/L 
<1.0 
>1.0 
Platelets ×109/L 
<50.0 
>50.0 
 
50% 
100% 
ANC = absolute neutrophil count. 
Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity 
If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, reduce the dosage by 
50% for the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, 
delay the next cycle until values return to normal or baseline and reduce the dose by 50% for the 
next course. 
7.5.1.3. 
PD-1 Inhibitor (Nivolumab) 
Dose modifications for nivolumab toxicities per OPDIVO® package insert (OPDIVO US 
Prescribing Information) are presented in Table 14. Additional modifications and use of 
corticosteroids are per local standard of care for PD-1 inhibitors should be discussed with 
Medical Monitor.  
 
 
 






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7.5.1.5. 
Cisplatin 
Ototoxicity: Monitoring for hearing loss is at the discretion of the treating investigator and dose 
modifications per local standard of care for high frequency hearing loss.   
Hematopoietic toxicity: Dose modifications for subsequent cycles of cisplatin are as follows:  
Total White 
Blood Cell 
Count (× 
106/L) 
 
Absolute 
Granulocyte Count 
(× 106/L) 
 
Platelet Count  
(× 106/L) 
% of Full 
Dose 
>4000 
And 
≥1500 
And 
≥100,000 
100 
any 
Or 
500-1499 
Or 
50,000-99,999 
75 
any 
Or 
<500 
Or 
<50,000 
Hold 
 
Nephrotoxicity:  Dose modifications are as follows:  
 
Creatinine Clearance 
% of Full Dose 
46—60 mL/min 
75 
<=45 mL/min 
Discontinue 
7.5.1.6. 
Continuing Single Agent FT-2102 in lieu of Combination Therapy 
If a patient is unable or unwilling to continue treatment with the combination agent (s) at any 
time, they may continue participation in the study taking FT-2102 alone, at the discretion of the 
Investigator. Doses held during a cycle will not be made up. Patients who discontinue treatment 
must be monitored per study procedure and assessment schedule, unless they withdraw consent. 
Any patient who requires an additional dose reduction below 150 mg once daily will be 
permanently discontinued from study drug. 
7.6. 
Drug Accountability 
The Investigator  or designee is responsible for taking an inventory of each shipment of 
investigational product (FT-2102) received and comparing it with the accompanying drug order 
form. 
All unused FT-2102 will be retained at the site. After full drug accountability and reconciliation, 
the Investigator will dispose of any study drug at the clinical trial site per site procedures, or if 
necessary, all FT-2102 will be returned to the Sponsor, or its designee. Disposition of all study 
drug should be documented, including any study drug is lost or damaged.  
7.7. 
Assignment to Treatment 
All patients will receive open-label FT-2102, or FT-2102 in combination, at a dose and regimen 
based on the study design (see Section 4). 


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8. 
SAFETY DATA COLLECTION, RECORDING, AND 
REPORTING 
8.1. 
Adverse Events  
8.1.1. 
Definition of an Adverse Event 
An AE is defined as any untoward medical occurrence associated with the use of a drug, or with 
study participation, whether or not considered related to study treatment.  
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding, for example), symptom, or disease temporally associated with the use of the medicinal 
product, whether or not considered related to the medicinal product.  
AEs include worsening of a pre-existing medical condition, as well as clinically significant 
changes from baseline laboratory values/conditions. Worsening of the preexisting medical 
condition (e.g., diabetes, hypertension) means that it has increased in CTC grade as compared to 
baseline. A pre-existing condition that has not worsened during the study is not considered an 
AE. 
8.1.2. 
Definition of Serious Adverse Event  
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 
• Results in death 
• Is immediately life-threatening 
• Requires inpatient hospitalization or prolongation of existing hospitalization.  
- 
Elective or pre-planned treatment for a pre-existing condition that is 
unrelated to the indication under study and has not worsened since signing 
the ICF (as documented as medical history on the eCRF) is not considered 
an SAE 
- 
Scheduled therapy for the target disease of the study, including admissions 
for transfusion support or convenience, is not considered an SAE 
• Results in persistent or significant disability/incapacity 
• Results in congenital anomaly/birth defect 
• Is considered an important medical event 
- 
If an AE does not meet one of the serious criteria, but the Investigator or 
Sponsor considers an event to be clinically important, the event could be 
classified as an SAE under the criterion of “Important medical event.” 
Examples of such medical events may include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home; blood 
dyscrasias or convulsions that do not result in inpatient hospitalization. 


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8.2. 
Procedures for Recording, and Reporting Adverse Events 
8.2.1. 
Recording Adverse Events 
Patients will be instructed to report all AEs and will be asked a general health status question at 
each study visit. All SAEs occurring in patients will be recorded in the eCRF from the time of 
signing the ICF through 28 days after the last dose of FT-2102 (and for 150 days following last 
dose of nivolumab if applicable). All AEs occurring in treated patients will be recorded in the 
eCRF from the time of first dose through 28 days (and for 150 days following last dose of 
nivolumab if applicable).  after the last dose of FT-2102. An AE will be followed until it is either 
resolved, has returned to baseline, or is determined to be a stable or chronic condition.  
All SAEs occurring from the signing of ICF through 28 days after the last dose of FT-2102 (and 
for 150 days following last dose of nivolumab if applicable) will be processed as outlined in 
Section 8.2.2.  
All AESIs, as defined in Section 8.2.3, from first dose of study drug through 28 days after the 
last dose of FT-2102 will be processed as outlined in Section 8.2.3. 
At each required visit during the trial, all AEs that have occurred since the previous visit must be 
reviewed by the Investigator. The Investigator must determine if the AE is serious or 
non-serious.  
The Investigator must assign the following AE attributes: 
• AE diagnosis or syndrome(s) if known 
• If not known at time of the report, record the signs and/or symptoms as AEs and 
provide an updated report with diagnosis when obtained 
• Dates of onset and resolution 
• Severity as defined per protocol 
• Assessment of relatedness to each study drug 
• Action taken with each study drug as a result of the AE 
In general, an AE that is the primary cause of subsequent events should be identified by the 
primary cause (e.g., for dehydration due to diarrhea, the AE would be diarrhea). However, AEs 
occurring secondary to an initiating event that are separated in time should be recorded as 
independent events (e.g., sepsis secondary to pneumonia, both events should be recorded).  
The signs and symptoms of progressive disease that meet the AE criteria should be reported as 
specific AEs, and not as disease progression.  
8.2.1.1. 
Relationship to Study Drug 
The Investigator must assess whether the AE may be related to each study drug or study 
mandated procedure, when applicable. The relationship is defined below:   
Relationship assessments that indicate the event is “Not Drug Related”: 
• None:  The event is related to an etiology other than the study product administration 
(the alternative etiology must be documented in the study patient’s medical record). 


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• Remote:  The event is unlikely to be related to the study product and likely to be 
related to factors other than study product. 
Relationship assessments that indicate the event is “Drug Related”: 
• Possible: There is an association between the event and the administration of 
FT-2102, and there is a plausible mechanism for the event to be related to the study 
product; but there may also be alternative etiology, such as characteristics of the 
patient’s clinical status or underlying disease. 
• Probable: There is an association between the event and the administration of 
FT-2102, there is a plausible mechanism for the event to be related to the study 
product, and the event could not be reasonably explained by known characteristics of 
the patient’s clinical status or an alternative etiology is not apparent. 
• Definite: There is an association between the event and the administration of 
FT-2102, there is a plausible mechanism for the event to be related to the study 
product and causes other than FT-2102 have been ruled out and/or the event 
re-appeared on re-exposure to FT-2102. 
8.2.1.2. 
Adverse Event Severity 
The Investigator will assess the Grade of the AE per the NCI CTCAE v. 4.03. Toxicities that are 
not specified in NCI CTCAE will be defined as follows:  
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
• Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL) 
• Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care ADL 
• Grade 4: Life-threatening consequences; urgent intervention indicated 
• Grade 5: Death related to AE 
Note: it is important to distinguish between SAEs and severe AEs. Severity is a measure of 
intensity, whereas seriousness is classified by the criteria based on the regulatory definitions as 
described in Section 8.1.2 above. 
8.2.1.3. 
Abnormal Laboratory and Electrocardiogram Values 
The Investigator is responsible for reviewing clinical laboratory test and ECG results and 
determining whether an abnormal value in a patient represents a clinically significant change 
from patient’s baseline value. In general, abnormal laboratory findings and ECGs without 
clinical significance (based on the Investigator's judgment) should not be recorded as AEs. In 
general, an abnormal laboratory test and ECG results should be reported as an AE if the 
laboratory result: 
• Requires an adjustment or discontinuation of study drug  


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• Requires treatment or adjustment to concomitant medications 
• Is considered to be an AE by the Investigator 
8.2.1.4. 
Medication Errors, Misuse, and Abuse of Study Drug 
Overdose, medication error, misuse, and abuse are defined as follows: 
• Overdose: refers to the administration of a quantity of study drug given per 
administration or cumulative, which is above the maximum dose according to the 
protocol.  
• Medication error: refers to an unintentional error in dispensing or administration of 
study drug not in accordance with the protocol 
• Off-label use: relates to situations where the study drug is intentionally used for 
medical purpose not in accordance with the protocol 
• Misuse: refers to situations where the study drug is intentionally and inappropriately 
used not in accordance with the protocol 
• Abuse: corresponds to the persistent or sporadic, intentional excessive use of the 
study drug, which is accompanied by harmful physical or psychological effects 
• Occupational exposure: refers to the exposure to the study drug because of one’s 
professional or non-professional occupation 
Overdoses, medication errors, abuse, or misuse will be collected as part of investigational 
medicinal product dosing information and/or as a protocol violation, as required.  
8.2.2. 
Reporting of Serious Adverse Events 
An SAE Report Form will be completed and submitted to FORMA Therapeutics 
Pharmacovigilance within 24 hours of the Investigator’s first knowledge of the event, even if the 
experience does not appear to be related to study drug, from the time of signing ICF through 
28 days after the last dose of FT-2102 (and for 150 days following last dose of nivolumab if 
applicable).  
Please refer to the SAE Report Form and completion guidelines on where and how to 
submit the form.  
The initial SAE report form must be as complete as possible, including details of the current 
illness and SAE, and an assessment of the relationship between the event and study drug. 
Additional information relating to a previously reported SAE must also be reported within 
24 hours of the Investigator’s first knowledge of information. The Investigator may also be 
asked, by the Sponsor, to provide clarifications or additional information. 
If the Investigator becomes aware of an SAE considered related to study drug by the 
Investigator, occurring more than 28 days after the last dose of FT-2102 (and for 150 days 
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8.2.2.1. 
Reporting of Serious Adverse Events to Regulatory Authorities, Ethics 
Committee, and Institutional Review Board 
The Sponsor will determine expectedness of FORMA product for each reported SAE based on 
the appropriate reference safety information per local requirements.  
The Sponsor or designee shall notify regulatory authorities of serious, unexpected, and related 
AEs or other AEs, per local requirements.  
The Sponsor or designee shall notify the Investigator of serious, related, and unexpected AE(s) 
submitted to the regulatory agencies, per local country requirements.  
The Sponsor or designee shall notify any applicable Central Institutional Review Boards 
(CIRBs) and Central Ethics Committees (CECs) of serious, related, and unexpected AE(s), or 
significant risks to patients, per country requirements. 
The Investigator will notify the appropriate IRB/Local Ethics Committees (LECs) of serious, 
related, and unexpected AE(s), or significant risks to patients, per local country requirements. 
The Investigator must keep copies of all AE information on file, including correspondence with 
FORMA or IRBs/LECs. 
8.2.3. 
Reporting of Adverse Events of Special Interest 
As described in Section 6.8.2, adverse events potentially associated with liver injury have been 
identified as AESI. These AESI (regardless if serious or non-serious) include the following: 
a.
All events of Grade 2 or higher elevations in ALT, AST, or total bilirubin in patients with
normal LFTs at baseline; in patients with elevated LFTs at baseline, one Grade shift or
higher in ALT, AST, or total bilirubin;
b. Any hepatic adverse event, e.g., acute hepatitis, cholestatic hepatitis, cholestasis, or
hepatic insufficiency
AESI occurring from time of first dose through 28 days after last dose must be reported as 
outlined below: 
a.
Report to FORMA Therapeutics Pharmacovigilance within 24 hours of knowledge of
event
b. If the event meets both AESI and SAE criteria, complete both the SAE and AESI form
c.
If the event is non-serious, complete the AESI form alone
Relevant forms (AESI, SAE, or both) should be submitted via fax (
) or email 
to FORMA Therapeutics Pharmacovigilance. 
8.2.4. 
Pregnancy and In Utero Drug Exposure 
FT-2102 has not been evaluated in pregnant or nursing women. Thus, pregnant women or 
women of childbearing potential who are not using effective contraception are excluded from 
this study (see Section 6.8.4 for instructions on birth control and pregnancy testing). 
Pregnancies occurring in patients, or partners of male patients are considered immediately 
reportable events if the pregnancy occurs during the study treatment through 90 days after the 
patient’s last dose of study drug. If a pregnancy occurs in a patient, study drug must be 
discontinued immediately. The pregnant woman should be referred to an 


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obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and 
counseling. 
The pregnancy must be reported to FORMA Therapeutics Pharmacovigilance within 24 hours of 
the Investigator’s knowledge of the pregnancy using the Pregnancy Report Form.  
The Investigator will follow the pregnant patient (or pregnant partner of male patient) until 
completion of the pregnancy and must notify the Sponsor of the pregnancy outcome within 
24 hours of the Investigator’s knowledge of the outcome. The Investigator will provide this 
information on the Pregnancy Report Form.  
If the pregnant patient (or pregnant partner of a male patient) experiences an SAE during 
pregnancy, or the outcome of the pregnancy meets any of the serious criteria (ie, spontaneous 
abortion [any congenital anomaly detected in an aborted fetus is to be documented], stillbirth, 
neonatal death, or congenital anomaly), the Investigator should follow the procedures for 
reporting SAEs (ie, report the event to FORMA Therapeutics Pharmacovigilance within 24 hours 
of the Investigator’s knowledge of the event). 
All neonatal deaths and congenital anomalies that occur within 30 days of birth (regardless of 
causality) should be reported as SAEs to FORMA Therapeutics Pharmacovigilance. In addition, 
any infant death or congenital anomaly occurring after 30 days that the Investigator suspects is 
related to the in utero exposure to the study drug should also be reported to FORMA 
Therapeutics Pharmacovigilance.  
Please refer to the Pregnancy Report Form and associated completion guidelines on where 
and how to submit the form.  
8.2.5. 
Disease Progression  
If progression of the underlying disease (i.e., the condition being treated with study drug) might 
be reasonably anticipated given the nature and severity of the underlying disease, then 
progression of the underlying disease per se will not constitute an AE. However, if the 
progression of the underlying disease meets the criterion for “serious” categorization of AEs 
(e.g., the underlying disease results in death or hospitalization), then the progression of 
underlying disease should be reported as an SAE (Section 8.1.2). 


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9. 
STATISTICAL METHODS 
Details of the statistical methods for this study will be documented in a Statistical Analysis Plan 
(SAP). The SAP may modify the statistical methods outlined in the protocol; however, any major 
modification will also be reflected in a protocol amendment. 
9.1. 
Sample Size 
This study will enroll up to approximately 200 patients.  
A single-agent Safety Lead-in Period will be implemented that may enroll approximately 
12 patients, which includes approximately 6 patients with glioma and 6 patients with solid 
tumors. Following successful completion of the Safety Lead-in Period, the study will then enroll 
4 disease-specific cohorts examining FT-2102 as either a single agent or in combination. These 
cohorts include Cohort 1 (glioma) with approximately 16-46 patients; Cohort 2 (HBC) with up to 
approximately 21-78  patients; Cohort 3 (chondrosarcoma) with approximately 16-46 patients; 
and Cohort 4 (IHCC) with approximately 21-78 patients.  There will be a fifth cohort of R132X 
IDH1 mutant solid tumors, non-CNS with up to 6 patients, single-agent only. 
Cohort 1a, Cohort 2a, Cohort 3a (single-agent FT-2102) 
Cohorts, 1a, 2a and 3a  will employ an optimal Simon’s 2-Stage design with a 1-sided alpha of 
0.025, power of 80%, null hypothesis of 5% and alternative hypothesis of 25%. Stage 1 of each 
of these cohorts will evaluate 8 patients for efficacy over 4 treatment cycles; if there are 1 or 
more responses, Stage 2 will initiate with additional 15 patients. If there are 4 or more responses 
out of the total 23 patients, the null hypothesis of 5% will be rejected. If there is no response in 
Stage 1 with single-agent FT-2102, or if the null hypothesis is not rejected at the end of Stage 2, 
combination therapy may be evaluated.  
Cohort 4a (single-agent FT-2102) 
Cohort 4a employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 
80%, null hypothesis of 8% and alternative hypothesis of 35%. Stage 1 will evaluate 8 patients 
and if there are 2 or more responses Stage 2 will initiate with additional 14 patients. If there are 5 
or more responses out of the total 22 patients, the null hypothesis of 8% will be rejected.  If there 
is 0 or 1 response in Stage 1 with single-agent FT-2102, or if the null hypothesis is not rejected at 
the end of Stage 2, combination may be evaluated. 
Combination Cohorts (1b, 2b, 3b, 4b)  
If there is no response in Stage 1 with single-agent FT-2102 combination cohorts may be 
examined. 
Cohort 1b and Cohort 3b 
For Cohorts 1b and 3b (combination therapy), an optimal Simon’s 2-Stage design will be 
implemented with a 1-sided alpha of 0.025, 80% power, with a null hypothesis of 5% and 
alternative hypothesis of 25%. Stage 1 of each cohort will evaluate 8 patients for efficacy over 
4 treatment cycles; if there are 1 or more responses, Stage 2 will initiate with additional 
15 patients. If there are 4 or more responses out of the total 23 patients, the null hypothesis of 5% 
will be rejected.  


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Cohort 2b  
Cohort 2b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 
80%, null hypothesis of 20% and alternative hypothesis of 40%. Stage 1 will evaluate 13 patients 
for efficacy; if there are 4 or more responses Stage 2 will initiate with an additional 42 patients. 
If there are 17 or more responses out of the total 55 patients, the null hypothesis of 20% will be 
rejected.   
Cohort 4b  
Cohort 4b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, power of 
80%, null hypothesis of 20% and alternative hypothesis of 40%. Stage 1 will evaluate 13 patients 
and if there are 4 or more responses Stage 2 will initiate with additional 42 patients. If there are 
17 or more responses out of the total 55 patients, the null hypothesis of 20% will be rejected.   
Cohort 5 
Cohort 5, due to the diverse population, this is an exploratory cohort without pre-defined 
efficacy/futility determinations (n=6).  
9.2. 
Analysis Sets 
9.2.1. 
Dose-Limiting Toxicity-Evaluable Analysis Set 
The DLT-Evaluable Analysis Set is defined as all patients in the Safety Lead-in Periods (single- 
agent FT-2102, combination FT-2102 + 5-azacitidine, combination FT-2102 + GemCis and 
combination FT-2102 + PD-1 inhibitor) who either experienced a DLT during Cycle 1 or 
completed at least 75% of the prescribed Cycle 1 dose. This analysis sets will be used to assess 
the tolerability of FT-2102 
9.2.2. 
Safety Analysis Set 
The Safety Analysis Set is defined as all patients who received any amount of study drug(s) 
(FT-2102 and combination agents, if appropriate).  
This analysis set will be the primary analysis set for all safety endpoints, excluding DLT 
evaluation. Safety analysis will be by cohort and by treatment within cohort if more than 1 dose 
or dosing combination are initiated for a particular indication cohort. 
9.2.3. 
Response-Evaluable Analysis Set 
The Response-Evaluable Analysis Set is defined as all patients with measurable disease at 
baseline are included in the Safety Analysis Set and had at least 1 post-baseline response 
assessment or discontinued the treatment phase due to disease progression (including death 
caused by disease progression) within 8 weeks (+2-week window) of the first dose of study 
treatment. This analysis set will be the primary analysis set for efficacy endpoints. All response 
evaluations will be by cohort, and by treatment within cohort if more than 1 doses or dosing 
combinations are initiated for a particular indication cohort. 


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9.2.4. 
Pharmacokinetics Analysis Set 
The PK analysis set is defined as all patients who received at least one dose of FT-2102 and had 
at least one measurable concentration.  
9.2.5. 
Pharmacodynamics Analysis Set 
The Pharmacodynamics analysis set is defined as all patients who received at least one dose of 
FT-2102 and have completed at least one pharmacodynamic assessment.  
 
9.3. 
Background Characteristics 
9.3.1. 
Patient Disposition 
The number and percentage of patients in each disposition category (e.g., enrolled, included in 
each Analysis Set, completing a given number of treatment cycles, discontinuing treatment, and 
discontinuing study, with a breakdown of the reasons for discontinuation) will be summarized by 
cohort. 
9.3.2. 
Demographics and Baseline Characteristics 
The following demographics and baseline characteristics will be summarized by cohort for the 
Safety Analysis Set: sex, race, age, type of cancer, tumor stage (tumor-node-metastases), ECOG 
performance status, time elapsed since cancer diagnosis, and prior anti-cancer therapies. 
Additional parameters may be provided in the SAP.  
9.4. 
Study Drug Exposure and Compliance 
Total number of cycles is defined as the maximum number of treatment cycles that a patient 
receives. Total cumulative dose (mg) is the sum of the actual doses that the patient receives 
across cycles. Total planned dose (mg) is the sum of the planned doses. The total number of days 
on treatment, total number of cycles, total cumulative dose (mg), total planned dose (mg) will be 
summarized. 
The study drug exposure will be summarized based on the Safety Analysis Set by cohort and 
dose level. 
9.5. 
Efficacy Analyses 
All analysis in this section will be based on patients in the Response-Evaluable Analysis Set 
unless otherwise specified.  
Best response will be summarized as determined by applicable disease criteria, for disease 
specific cohorts (see Appendix 2 for definitions). RANO (LGG) for low-grade glioma, RANO 
for high-grade glioma, RECIST 1.1 for cholangiocarcinoma, HBC and other solid tumors.  
ORR is defined as follows: 
• Glioma: the proportion of patients with a best response of CR or PR or MR (LGG) 
• HBC: the proportion of patients with a best response of CR or PR 


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• Chondrosarcoma: the proportion of patients with a best response of CR or PR 
• Cholangiocarcinoma: the proportion of patients with a best response of CR or PR  
It will be summarized by cohort and tabulated with 90% confidence interval estimated using 
Clopper-Pearson method. 
Time to event data will be analyzed using Kaplan-Meier (KM) methods for each cohort. The 
median time will be tabulated along with the 95% confidence intervals. The estimated 
probability of survival over time will be plotted as KM curves for each cohort (or by disease type 
and by treatment).  
For time to event variables, the following is considered:  
• PFS will be defined for all patients in the Response Evaluable Analysis Set. It is the 
time between first dose of study drug and disease progression, death from any cause, 
or start of other (non-protocol study drug) new anticancer therapy, whichever occurs 
first. For a patient with none of these events before the end of study follow-up, PFS 
will be censored on the date of the last follow-up examination. 
• TTR will only be defined for patients who achieve a response (CR/ PR). It is the time 
between the first dose of study drug and documentation of the first response by 
applicable disease criteria. 
• DOR will be defined only for patients who achieve a response. It is the time between 
documentation of the response by appropriate disease assessment until the date of 
progression or any new anticancer therapy, whichever is earlier. For patients who die 
without documentation/report of disease progression, DOR will be censored on the 
date of death, regardless of cause, or any other new anticancer therapy (non-protocol 
study drug), whichever is earlier. For patients with no report of disease progression 
by the end of the follow-up data collection, DOR will be censored on the date of the 
last follow-up examination. Since DOR is patient to the competing risk of death 
without progression, estimates of the cumulative incidence of progression will be 
reported for each cohort. Similarly, the duration of overall response will also be 
analyzed.  
• OS will be defined based on the Safety Analysis Set. It is the time from study entry 
until death from any cause. For patients who are not known to have died by the end of 
study follow-up, OS will be censored on the date the patient was known to be alive. 
Patients who are lost to follow up with be censored on the last date the patient was 
known to be alive.  The percentage of patients who are alive will be estimated at 
selected landmark timepoints such as 3 months, 6 months, etc.  
• TTP will be defined for all patients in the Response Evaluable Analysis Set. It is the 
time between first dose of study drug and disease progression. Death from any cause 
or start of other (non-protocol study drug) new anticancer therapy are censoring 
events. For a patient with none of these events before the end of study follow-up, TTP 
will be censored on the date of the last follow-up examination. 
Additional efficacy analyses will be specified in the SAP. 


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9.6. 
Safety Analyses 
The Safety Analysis set will be used to evaluate all safety endpoints unless the endpoints are 
applicable to only selected patients, e.g., DLT. 
9.6.1. 
Adverse Events 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 
19.1 or higher and will be graded according to the NCI CTCAE, version 4.03.  
A TEAE is an AE that begins or worsens in the period from the first dose of study treatment to 
28 days after the last dose of FT-2102. 
Summaries of AEs will be based on TEAEs. TEAEs will be summarized separately for each 
cohort and dose by the number of patients experiencing TEAEs corresponding to MedDRA 
System Organ Classes (SOCs) and Preferred Terms (PTs) by highest grade.  
Separate tabulations will also be produced for TEAEs assessed as related to study drug, TEAEs 
that led to treatment discontinuation, TEAEs that led to death, and TEAEs ≥Grade 3 in severity. 
Common AEs will be summarized by MedDRA PT from most to least common.  Treatment-
emergent SAEs and SAEs related to study drug will also be tabulated.  A summary of 
non-serious TEAEs will also be produced. 
9.6.2. 
Clinical Laboratory Assessments 
All statistical analyses of laboratory values will be performed using SI units. 
A summary of hematology, chemistry, and coagulation laboratory parameters will be performed 
using descriptive statistics on the raw values and change from baseline by dose group, disease, 
and nominal visit.  
Shifts in Grade from baseline to the maximum post-baseline grade will be summarized by 
treatment group for applicable laboratory data. Laboratory values ≥Grade 3 in severity will be 
tabulated by treatment group. 
A listing of individual patient hematology, serum chemistry, and coagulation values outside the 
reference ranges will be provided. This listing will include data from scheduled and unscheduled 
time points. 
9.6.3. 
Electrocardiogram 
A summary of raw values and change from baseline values by dose group and disease for each 
scheduled visit will be provided for ECG parameters. 
QTc intervals based on Fridericia’s correction method will be summarized by dose. The number 
and percentage of patients will be presented for each of the following categories of QTcF 
intervals (≤480 ms, >480 to ≤500 ms, >500 ms). The number and percentage of patients will also 
be presented for each of the following categories of changes from baseline >30 to ≤60 ms, >60 
ms).  


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9.7. 
Pharmacokinetic Analyses 
PK analyses will be conducted on patients in the PK Analysis Set. PK parameters based on the 
actual sample collection times will be determined using standard noncompartmental methods. 
The PK parameters to be assessed include, but are not necessarily limited to:   
Cmax  
Maximum observed plasma concentration  
tmax  
Time of maximum observed plasma concentration  
AUC0-last   
Area under the plasma concentration-time curve from time zero to the last 
quantifiable time point  
AUC0-INF  
Area under the plasma concentration-time curve from time zero extrapolated to 
infinity (may be estimated when sufficient data allows)  
t1/2   
Terminal elimination half-life (may be estimated when sufficient data allows) 
Evaluations of PK data will include accumulation upon multiple-dose administration, PK/PD 
relationship, and exposure/QTc analysis.  
9.8. 
Pharmacodynamic Analyses  
Pharmacodynamic analyses will be descriptive in nature. In general, pharmacodynamic 
parameters will be summarized by cohort and nominal visit Summary tabulations may be 
produced if data from a sufficient number of patients are collected.  


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10. 
STUDY ADMINISTRATION 
10.1. 
Good Clinical Practice Statement 
This study is to be performed in accordance with the protocol, the Declaration of Helsinki, the 
International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good 
Clinical Practice (GCP), and all applicable local regulatory requirements. 
10.2. 
Informed Consent 
FORMA or its designee will provide a sample patient ICF for modification, as appropriate, by 
the Investigator. The ICF must include all elements required by ICH and GCP and must adhere 
to the IRB/IEC requirements and the ethical principles that have their origin in the Declaration of 
Helsinki. 
The Investigator or his/her staff will explain the nature of the study, its purpose and associated 
procedures, the expected duration, and the potential risks involved to the patient prior to 
enrollment. The Investigator or designee will obtain written, informed consent. The patient will 
have ample time and opportunity to ask questions and will be informed about the right to 
withdraw from the study at any time without any disadvantage and without having to provide a 
reason for this decision. Following the discussion regarding the study, a patient will be asked if 
they are willing to sign and personally date a statement of informed consent. Only if the patient 
voluntarily agrees to sign the informed consent statement and has done so, may he/she enter the 
study. A copy of the signed and dated ICF will be provided to the patient. The signed ICF is to 
remain in the Investigator’s file, per local requirements. 
The ICF and any other written information provided to the patients will be revised whenever 
important new information becomes available that may be relevant to the patient’s consent, or if 
there is an amendment to the protocol which necessitates a change to the content of the patient’s 
informed consent. The Investigator will inform the patients of changes in a timely manner and 
will ask the patients to confirm continuation of their participation in the study by their signature 
on the revised ICF (if applicable). Any written ICF and written information must receive the 
approval/favorable opinion of the IRB/IEC in advance of use. Any additional approvals from the 
initial ICF should be forwarded to the Sponsor. 
10.3. 
Patient Confidentiality 
The written ICF will explain that study data will be stored in a database, maintaining 
confidentiality in accordance with national data legislation. All data processed by FORMA or its 
representative(s) will be identified by patient number and study code. 
The written ICF will also explain that for data verification purposes, authorized representatives 
of FORMA, a regulatory authority, and an IRB/IEC may require direct access to parts of the 
hospital or clinic records relevant to the study that include the patient’s medical history. 
The Investigator must ensure that the patients’ anonymity is maintained. On the eCRFs or other 
documents submitted to the Sponsor, patients should not be identified by their names, but by 
their assigned patient number and study code. Documents not for submission to the Sponsor, 
such as signed ICF, should be maintained in strict confidence by the Investigator. 


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10.4. 
Institutional Review Board/Ethics Committee Requirements 
The final study protocol, including the final version of the ICF, must be approved or given a 
favorable opinion in writing by an IRB/IEC at each clinical trial site. The Principal Investigator 
must submit written approval to FORMA before he or she can enroll any patient into the study. 
The Principal Investigator is responsible for informing the IRB/IEC of any amendment to the 
protocol. In addition, the IRB/IEC must approve all advertising used to recruit patients for the 
study. The protocol must be re-approved by the IRB/IEC annually or as applicable. 
Progress reports and notifications of SAEs will be provided to the IRB/IEC according to 
regulations and guidelines. 
10.5. 
Case Report Forms and Source Documentation 
eCRFs will be provided for the recording of all data. The Principal Investigator/Sub-Investigator 
or designee will record data from all observations, tests, and assessments specified in the 
protocol on the eCRFs provided. 
In place of recording patient data on paper CRFs, which will not be used in this study, site 
personnel are responsible for entering such data into the Electronic Data Capture (EDC) system 
in a timely manner. This system has been validated and is compliant with FDA, ICH, and 
European Union (EU) regulations and guidelines and with Department of Health and Human 
Services 21 CFR Part 11 rules for electronic records and electronic signatures. No data will be 
requested other than what is routinely written on paper CRFs.  
An audit may be performed at any time during or after completion of the clinical study by 
Sponsor personnel or their designee. All study-related documentation must be made available to 
the designated auditor. 
10.6. 
Sponsor Monitoring 
Before the first patient is enrolled into the study, a representative of FORMA will visit the study 
site to: 
• Determine the adequacy of the facilities 
• Discuss with the Investigator(s) (and other personnel involved with the study) their 
responsibilities with regard to the protocol and the responsibilities of FORMA  
During the conduct of the study, a representative of FORMA will have regular contact with the 
clinical trial site, and have regular visits to the clinical trial site to: 
• Provide information and support the PI 
• Confirm that the facilities remain acceptable 
• Confirm that the study team is adhering to the protocol, data are being accurately 
recorded in the eCRFs, and the investigational product is being properly maintained 
and accountability records are current 
• Perform source data verification with access to all original clinical records for each 
patient 


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10.7. 
Data Monitoring Committee 
There will be no formal Independent Data Monitoring Committee.  
10.8. 
Quality Assurance 
In compliance with GCP and regulatory requirements, the Sponsor, a third party on behalf of the 
Sponsor, regulatory agencies or IRB/IECs may conduct quality assurance audits at any time 
during or following a study. The Investigator must agree to allow auditors direct access to all 
study-related documents including source documents and must agree to allocate his or her time 
and the time of his or her study staff to the auditors in order to discuss findings and issues. 
10.9. 
Study or Clinical Site Termination 
FORMA, or designee, reserves the right to terminate the study or a clinical trial site at any time. 
Conditions that may warrant termination of the study include, but are not limited to: 
• The discovery of an unexpected, serious, or unacceptable risk to patients enrolled in 
the study 
• The decision on the part of FORMA to suspend or discontinue testing the study 
treatment 
• Failure of the Investigator to comply with GCP 
• Submission of knowingly false information from the clinical trial site to FORMA or 
regulatory authorities 
• Insufficient adherence to protocol requirements 
If terminating the study, FORMA and the Investigator(s) will assure that adequate consideration 
is given to the protection of the patients’ interests. 
10.10. 
Duration of the Study, Expected Duration of Patient Participation, 
and End of Study 
Patients assigned to receive FT-2102 will continue this treatment until documented disease 
progression or unacceptable toxicity.  
The end of the study will be defined as last patient last visit (LPLV).  
10.11. 
Records Retention 
All correspondence related to this clinical study should be kept in appropriate study files. 
Records of patients, source documents, eCRFs, study drug inventory, IRB, and Sponsor 
correspondence pertaining to this study must be kept on file. All study documents must be kept 
secured for a period of 2 years after  marketing applications are approved for FT-2102, or until 
2 years after shipment and delivery of the study drug for investigational use if discontinued or as 
long as required by local regulations in any country participating in the trial, whichever is longer. 
There may be other circumstances for which the Sponsor is required to maintain study records 
and, therefore, the Sponsor should be contacted prior to removing or relocating study records for 
any reason. 


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10.12. 
Publications 
Publication by the clinical trial site(s) of any data from this study must be carried out in 
accordance with the Clinical Trial Agreement. 


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11. 
REFERENCES 
Amary MF, Bacsi K, Maggiani F, et al. IDH1 and IDH2 mutations are frequent events in central 
chondrosarcoma and central and periosteal chondromas but not in other mesenchymal tumours. J 
Pathol. 2011;224(3):334-43. 
Birendra KC, DiNardo CD. Evidence for clinical differentiation and differentiation syndrome in 
patients with acute myeloid leukemia and IDH1 mutations treated with the targeted mutant IDH1 
inhibitor, AG-120. Clin Lymphoma Myeloma Leuk. 2016;16(8):460-5. 
Borodovsky A, Salmasi V, Turcan S, et al. 5-azacytidine reduces methylation, promotes 
differentiation and induces tumor regression in a patient-derived IDH1 mutant glioma xenograft. 
Oncotarget. 2013;4(10):1737-47. 
Cairns RA, Mak TW. Oncogenic isocitrate dehydrogenase mutations: mechanisms, models, and 
clinical opportunities. Cancer Discov. 2013;3(7):730-41. 
Cheson BD, Fisher RI, et al. Recommendations for Initial Evaluation, Staging and Response 
Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. JCO. 2014; 
32(27): 3059-3067. 
Cowan LA, Talwar S, Yang AS. Will DNA methylation inhibitors work in solid tumors? A 
review of the clinical experience with azacitidine and decitabine in solid tumors. Epigenomics. 
2010;2(1):71-86. 
Eckmann KR, Patel DK, Landgraf A, et al. Chemotherapy outcomes for the treatment of 
unresectable intrahepatic and hilar cholangiocarcinoma: a retrospective analysis. Gastrointest 
Cancer Res. 2011;4(5-6):155-60. 
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: 
revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-47. 
El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular 
carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and 
expansion trial. Lancet. 2017;389(10088):2492-502. 
Frankel SR, Eardley A, Lauwers G, et al. The "retinoic acid syndrome" in acute promyelocytic 
leukemia. Ann Intern Med. 1992;117(4):292-6. 
Gemzar US Prescribing Information Indianapolis, IN, Eli Lilly and Company (Available at: 
https://pi.lilly.com/us/gemzar.pdf). 
Goyal L, Govindan A, Sheth RA, et al. Prognosis and clinicopathologic features of patients with 
advanced stage isocitrate dehydrogenase (IDH) mutant and IDH wild-type intrahepatic 
cholangiocarcinoma. Oncologist. 2015;20(9):1019-27. 


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Gross S, Cairns RA, Minden MD, et al. Cancer-associated metabolite 2-hydroxyglutarate 
accumulates in acute myelogenous leukemia with isocitrate dehydrogenase 1 and 2 mutations. J 
Exp Med. 2010;207(2):339-44. 
Ishii Y, Sigel C, Lowery MA, et al. AG-120 (ivosidenib), a first-in-class mutant IDH1 inhibitor, 
promotes morphologic changesand upregulates liver-specific genes in IDH1 mutant 
cholangiocarcinoma. Presented at the AACR-NCI-EORTC Conference; Abstract A071. 
Philadelphia, PA. 2017. 
Jelic S, Sotiropoulos GC, Group EGW. Hepatocellular carcinoma: ESMO Clinical Practice 
Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21 Suppl 5:v59-64. 
Juergens RA, Wrangle J, Vendetti FP, et al. Combination epigenetic therapy has efficacy in 
patients with refractory advanced non-small cell lung cancer. Cancer Discov. 2011;1(7):598-607. 
Laufer CB, Roberts O. Differentiation syndrome in acute myeloid leukemia after treatment with 
azacitidine. Eur J Haematol. 2015;95(5):484-5. 
Lee JH, Shin DH, Park WY, et al. IDH1 R132C mutation is detected in clear cell hepatocellular 
carcinoma by pyrosequencing. World J Surg Oncol. 2017;15(1):82. 
Losman JA, Looper RE, Koivunen P, et al. (R)-2-hydroxyglutarate is sufficient to promote 
leukemogenesis and its effects are reversible. Science. 2013;339(6127):1621-5. 
Lowery MA, Abou-Alfa GK, Burris HA, et al. Phase I study of AG-120, an IDH1 mutant 
enzyme inhibitor: Results from the cholangiocarcinoma dose escalation and expansion cohorts. 
Presented at the ASCO Annual Meeting; Abstract 4015. Chicago, IL. 2017. 
Lu C, Ward PS, Kapoor GS, et al. IDH mutation impairs histone demethylation and results in a 
block to cell differentiation. Nature. 2012;483(7390):474-8. 
Meijer D, de Jong D, Pansuriya TC, et al. Genetic characterization of mesenchymal, clear cell, 
and dedifferentiated chondrosarcoma. Genes Chromosomes Cancer. 2012;51(10):899-909. 
Mellinghoff IK, Touat M, Maher E, et al. AG-120, A first-in-class mutant IDH1 inhibitor in 
patients with recurrent or progressive IDH1 mutant glioma: updated results from the Phase 1 
non-enhancing glioma population. Presented at the Society for Neuro-Oncology Annual 
Meeting; Abstract ACTR-46. San Francisco, CA. 2017. 
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55. 
OPDIVO US Prescribing Information Princeton, NJ, Bristol-Myers Squibb Company (Available 
at: https://packageinserts.bms.com/pi/pi_opdivo.pdf). 
Peng D, Kryczek I, Nagarsheth N, et al. Epigenetic silencing of TH1-type chemokines shapes 
tumour immunity and immunotherapy. Nature. 2015;527(7577):249-53. 


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Platinol US Prescribing Information  Princeton, NJ, Bristol-Myers Squibb Company (Available 
at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf). 
Rohle D, Popovici-Muller J, Palaskas N, et al. An inhibitor of mutant IDH1 delays growth and 
promotes differentiation of glioma cells. Science. 2013;340(6132):626-30. 
Saha SK, Parachoniak CA, Ghanta KS, et al. Mutant IDH inhibits HNF-4alpha to block 
hepatocyte differentiation and promote biliary cancer. Nature. 2014;513(7516):110-4. 
Tap W, Villalobos VM, Cote GM, et al. A phase 1 study of AG-120, an IDH1 mutant enzyme 
inhibitor: results from the chondrosarcoma dose escalation and expansion cohorts. Presented at 
the Connective Tissue Oncology Society Annual Meeting; Abstract P1-138. Lisbon, Portugal. 
2016. 
Turcan S, Fabius AW, Borodovsky A, et al. Efficient induction of differentiation and growth 
inhibition in IDH1 mutant glioma cells by the DNMT inhibitor decitabine. Oncotarget. 
2013;4(10):1729-36. 
Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary 
tract cancer. N Engl J Med. 2010;362(14):1273-81. 
van den Bent MJ, Wefel JS, Schiff D, et al. Response assessment in neuro-oncology (a report of 
the RANO group): assessment of outcome in trials of diffuse low-grade gliomas. Lancet Oncol. 
2011;12(6):583-93. 
VIDAZA US Prescribing Information Summit, NJ, Celgene Corporation (Available at: 
https://media.celgene.com/content/uploads/vidaza-pi.pdf). 
Wang P, Dong Q, Zhang C, et al. Mutations in isocitrate dehydrogenase 1 and 2 occur frequently 
in intrahepatic cholangiocarcinomas and share hypermethylation targets with glioblastomas. 
Oncogene. 2013;32(25):3091-100. 
Weber SM, Ribero D, O'Reilly EM, et al. Intrahepatic cholangiocarcinoma: expert consensus 
statement. HPB (Oxford). 2015;17(8):669-80. 
Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-
grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 
2010;28(11):1963-72. 
Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 
2009;360(8):765-73. 


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12. 
APPENDICES 
 
 
 


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APPENDIX 1. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS 
Grade 
ECOG 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature, e.g., light house work, office work 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. 
Up and about more than 50% of waking hours 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of 
waking hours 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or 
chair 
5 
Dead 
Source: Eastern Cooperative Oncology Group: http://www.ecog.org/general/perf_stat.html 
As published in Oken et al, 1982 
 
 
 


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APPENDIX 2. RESPONSE CRITERIA 
LGG/RANO (van den Bent et al, 2011) 
Complete response 
Complete response requires all the following criteria compared with the baseline scan: 
1. Complete disappearance of the lesion on T2 or FLAIR imaging (if enhancement had been 
present, it must have resolved completely) 
2. no new lesions, no new T2 or FLAIR abnormalities apart from those consistent with 
radiation effects, and no new or increased enhancement;  
3. patients must be off corticosteroids or only on physiological replacement doses; and  
4. patients should be stable or improved clinically 
Partial response 
Partial response requires all of the following criteria compared with the baseline scan: 
1. greater than or equal to 50% decrease in the product of perpendicular diameters of the 
lesion on T2 or FLAIR imaging sustained for at least 4 weeks compared with baseline; 
2. no new lesions, no new T2 or FLAIR abnormalities apart from those consistent with 
3. radiation effects, and no new or increased enhancement; and  
4. patients should be on a corticosteroid dose that should not be greater than the dose at time 
of baseline scan, and should be stable or improved clinically 
Minor response 
Minor response requires the following criteria compared with baseline:  
1. a decrease of the area of non-enhancing lesion on T2 or FLAIR MR imaging between 
25% and 50% compared with baseline;  
2. no new lesions, no new T2 or FLAIR abnormalities apart from those consistent with 
radiation effect, and no new or increased enhancement; and 
3. patients should be on a corticosteroid dose that should not be greater than the dose at time 
of baseline scan, and should be stable or improved clinically 
Stable disease 
Stable disease is present if the changes do not qualify for complete, partial, or minor response, or 
progression and requires:  
1. stable area of non-enhancing abnormalities on T2 or FLAIR imaging;  
2. no new lesions, no new T2 or FLAIR abnormalities apart from those consistent with 
radiation effect, and no new or increased enhancement; and 
3. patients should be on a corticosteroid dose that should not be greater than the dose at time 
of baseline scan, and should be stable or improved clinically 


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Progression 
Progression is defined by any of the following:  
1. development of new lesions or increase of enhancement (radiological evidence of 
malignant transformation);  
2. a 25% increase of the T2 or FLAIR non-enhancing lesion on stable or increasing doses of 
corticosteroids compared with baseline scan or best response after initiation of therapy, 
not attributable to radiation effect or to comorbid events;  
3. definite clinical deterioration not attributable to other causes apart from the tumor, or 
decrease in corticosteroid dose; or 
4. failure to return for evaluation because of death or deteriorating condition, unless caused 
by documented non-related disorders.  
 
 
 


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RANO (Wen et al, 2010): 
Complete Response 
Complete response requires all of the following with a confirming scan at least 4 weeks later. In 
the absence of the confirming scan, the response will be considered stable disease:  
1. complete disappearance of all enhancing measurable and nonmeasurable disease 
sustained for at least 4 weeks; and 
2. no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; and  
3. patient must be off corticosteroids or on physiologic replacement doses only, and 
4. stable or improved clinically.  
Partial Response 
Partial response requires all of the following (In the absence of a confirming scan at least 4 
weeks later, this response will be considered only stable disease):  
1. ≥50% decrease, compared with baseline, in the sum of products of perpendicular 
diameters of all measurable enhancing lesions sustained for at least 4 weeks; and 
2. no progression of nonmeasurable disease; and 
3. no new lesions; and 
4. stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of 
corticosteroids compared with baseline scan; and  
5. patient must be on a corticosteroid dose not greater than the dose at time of baseline scan 
and is stable or improved clinically.  
Stable Disease 
If the patient does not qualify for complete response, partial response, or progression (see next 
section) and requires the following: 
1.  stable nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids 
compared with baseline scan and clinically stable status. 
(In the event that the corticosteroid dose was increased for new symptoms and signs without 
confirmation of disease progression on neuroimaging, and subsequent follow-up imaging shows 
that this increase in corticosteroids was required because of disease progression, the last scan 
considered to show stable disease will be the scan obtained when the corticosteroid dose was 
equivalent to the baseline dose) 
Progression 
Progression is defined by any of the following (Failure to return for evaluation as a result of 
death or deteriorating condition should also be considered as progression):  
1. ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions 
(compared with baseline if no decrease) on stable or increasing doses of corticosteroids; 


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2.  a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of 
corticosteroids compared with baseline scan or best response after initiation of therapy, 
not due to comorbid events; or 
3. the appearance of any new lesions; or 
4. clear progression of nonmeasurable lesions; or 
5. definite clinical deterioration not attributable to other causes apart from the tumor, or to 
decrease in corticosteroid dose. 
Increase in corticosteroid dose alone, in the absence of clinical deterioration related to tumor, 
will not be used as a determinant of progression.  
*Patients with stable imaging studies whose corticosteroid dose was increased for reasons other 
than clinical deterioration related to tumor do not qualify for stable disease or progression. If 
their corticosteroid dose can be reduced back to baseline, they will be considered as having 
stable disease; if further clinical deterioration related to tumor becomes apparent, they will be 
considered to have progression. The date of progression should be the first time point at which 
corticosteroid increase was necessary. 
**The definition of clinical deterioration is left to the discretion of the treating physician, but it is 
recommended that a decline in the Karnofsky Performance Status (KPS) from 100 or 90 to 70 or 
less, a decline in KPS of at least 20 from 80 or less, or a decline in KPS from any baseline to 50 
or less, for at least 7 days, be considered neurologic deterioration unless attributable to comorbid 
events or changes in corticosteroid dose. Similarly, a decline in the Eastern Cooperative 
Oncology Group and WHO performance scores from 0 or 1 to 2 or 2 to 3 would be considered 
neurologic deterioration. 
 
RECIST 1.1 (Eisenhauer et al, 2009): 
 
Response 
Definition 
Complete Response (CR) 
Disappearance of all extranodal target lesions. All 
pathological lymph nodes must have decreased to <10 mm in 
short axis 
Partial Response (PR) 
At least a 30% decrease in the sum of diameters of target 
lesions, taking as a reference the baseline sum of diameters 
Stable Disease (SD) 
Neither sufficient shrinkage to qualify for PR nor sufficient 
increase to qualify for PD 
Progressive Disease (PD) 
Sum of diameters increased by at least 20% from the smallest 
value on study (including baseline, if that is the smallest) The 
sum of diameters must also demonstrate an absolute increase 
of at least 5 mm. (Two lesions increasing from 2 mm to 3 
mm, for example, does not qualify.) 
 
 


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APPENDIX 3. DRUGS AFFECTING QTC INTERVAL 
It has been recognized for a number of years that certain prescription medications can prolong 
the QT/QTc interval. Medications that prolong the QT interval and/or have a risk of inducing 
TdP are listed in Table 15. Additional information can be found at: 
https://crediblemeds.org/index.php. 
Table 15: 
Drugs that Prolong the QT Interval and/or Have a Risk of Inducing 
Torsade De Pointes  
Aclarubicin (Only on Non-US Market) 
Amiodarone 
Anagrelide 
Arsenic trioxide 
Astemizole (Removed from Market) 
Azithromycin 
Bepridil (Removed from Market) 
Chloroquine 
Chlorpromazine 
Cilostazol 
Ciprofloxacin 
Cisapride (Removed from Market) 
Citalopram 
Clarithromycin 
Cocaine 
Disopyramide 
Dofetilide 
Domperidone (Only on Non-US Market) 
Donepezil 
Dronedarone 
Droperidol 
Erythromycin 
Escitalopram 
Flecainide 
Fluconazole 
Gatifloxacin (Removed from Market) 
Grepafloxacin (Removed from Market) 
Halofantrine (Only on Non-US Market) 
Haloperidol 
Ibogaine (Only on Non-US Market) 
Ibutilide 
Levofloxacin 
Levomepromazine (Only on Non-US 
Market) 
Levomethadyl acetate (Removed from 
Market) 
Levosulpride (Only on Non-US Market) 
Mesoridazine (Removed from Market) 
Methadone 
Moxifloxacin 
Ondansetron 
Oxaliplatin 
Papaverine HCl 
Pentamidine 
Pimozide 
Probucol (Removed from Market) 
Procainamide 
Propofol 
Quinidine 
Roxithromycin (Only on Non-US Market) 
Sevoflurane 
Sotalol 
Sparfloxacin (Removed from Market) 
Sulpiride (Only on Non-US Market) 
Sultopride (Only on Non-US Market) 
Terfenadine (Removed from Market) 
Terlipressin (Only on Non-US Market) 
Terodiline (Only on Non-US Market) 
Thioridazine 
Vandetanib 
S
 
ource: www.AZCert.org accessed 19 June 2018 




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APPENDIX 5. DRUGS THAT ARE SENSITIVE SUBSTRATES OR 
STRONG INDUCERS OF CYP3A4 
Sensitive Substrates: 
Alfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, 
ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, 
sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, budesonide, dasatinib, dronedarone, 
eletriptan, eplerenone, felodipine, indinavir, lurasidone, maraviroc, quetiapine, sildenafil, 
ticagrelor, tolvaptan   
Strong Inducers: 
Carbamazepine, rifampin, ritonavir, enzulatamide, mitotane, phenytoin, phenobarbital and St. 
John’s wort 
Additional information can be found at: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti 
onsLabeling/ucm093664.htm#table3-1 

SAP_001.pdf: 


FORMA Therapeutics 
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28 June 2019, Version 2.0  
 
 
2 
TABLE OF CONTENTS 
Section 
Page 
1. 
Introduction and Objectives............................................................................................ 8 
1.1. 
Introduction .......................................................................................................... 8 
1.2. 
Study Objectives ................................................................................................... 8 
1.3. 
Study Endpoints ................................................................................................. 10 
1.4. 
Study Design ....................................................................................................... 11 
1.4.1. 
Synopsis of Study Design ..................................................................... 11 
1.4.2. 
Randomization Methodology ................................................................ 12 
1.4.3. 
Stopping Rules and Unblinding ............................................................ 12 
1.4.4. 
Study Procedures .................................................................................. 12 
1.4.5. 
Efficacy, Pharmacokinetic, Pharmacodynamic and Safety 
Parameters ............................................................................................. 12 
2. 
Patient Population .......................................................................................................... 15 
2.1. 
Analysis Sets ....................................................................................................... 15 
2.2. 
Protocol Violations ............................................................................................. 16 
3. 
General Statistical Methods .......................................................................................... 17 
3.1. 
Sample Size Justification ................................................................................... 17 
3.2. 
General Methods ................................................................................................ 18 
3.3. 
Computing Environment ................................................................................... 19 
3.4. 
Baseline Definitions ............................................................................................ 20 
3.5. 
Methods of Pooling Data ................................................................................... 20 
3.6. 
Adjustments for Covariates .............................................................................. 20 
3.7. 
Multiple Comparisons/Multiplicity .................................................................. 20 
3.8. 
Subpopulations ................................................................................................... 20 
3.9. 
Withdrawals, Dropouts, Loss to Follow-up ..................................................... 22 
3.10. Missing, Unused, and Spurious Data ............................................................... 22 
3.11. Visit Windows ..................................................................................................... 23 
3.12. Interim Analyses ................................................................................................ 23 
4. 
Study Analyses ................................................................................................................ 25 


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Section 
Page 
4.1. 
Patient Disposition ............................................................................................. 25 
4.2. 
Demographics and Baseline Disease Characteristics ...................................... 25 
4.3. 
Efficacy Evaluations .......................................................................................... 28 
4.3.1. 
Disease Response and Survival Analyses ............................................. 28 
4.3.2. 
Quality of Life Assessment Analysis .................................................... 32 
4.4. 
Pharmacokinetic and Pharmacodynamic Evaluations ................................... 33 
4.5. 
Safety Analyses ................................................................................................... 38 
4.5.1. 
Study Drug Exposure ............................................................................ 38 
4.5.2. 
Adverse Events ..................................................................................... 39 
4.5.3. 
Laboratory Data .................................................................................... 42 
4.5.4. 
Vital Signs and Physical Examination .................................................. 46 
4.5.5. 
Electrocardiogram ................................................................................. 46 
4.5.6. 
Concomitant Medications and Procedures ............................................ 47 
4.5.7. 
Performance Status ............................................................................... 48 
5. 
Exploratory Analyses ..................................................................................................... 49 
6. 
Changes to Planned Analyses ........................................................................................ 50 
7. 
References ....................................................................................................................... 51 
8. 
Clinical Study Report Appendices ................................................................................ 52 
8.1. 
Statistical Tables and Figures to be Generated ............................................... 53 
8.2. 
Data Listings to be Generated ........................................................................... 65 
9. 
Table and Figure Shells ................................................................................................. 67 
10. 
Data Listing Shells ....................................................................................................... 152 
11. 
Revision History ........................................................................................................... 199 
12. 
Study Schematic ........................................................................................................... 201 
 


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TABLES INCLUDED IN THE TEXT 
 
Page 
Table 1 
Pharmacokinetic Parameters for Analysis .......................................................................34 
 
 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
2-HG 
(R)-2-hydroxyglutarate 
AE 
Adverse event 
AFP 
Alpha-fetoprotein 
α-KG 
α-ketoglutarate 
ALP 
Alkaline phosphatase 
ALT (SGPT) 
Alanine aminotransferase (serum glutamic pyruvic transaminase) 
ANC 
Absolute neutrophil count 
AST (SGOT) 
Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) 
ATC 
Anatomic therapeutic class 
AUC 
Area under the concentration versus time curve 
AUC0-24 
Area under the concentration versus time curve from time 0 to the end of 
the dosing interval 24 hours later, calculated using linear trapezoid rule 
β-HCG 
Beta human chorionic gonadotropin 
BOR 
Best overall response 
BQL 
Below quantifiable limit 
Cmax 
Maximum plasma concentration 
Cmin 
Trough plasma concentration, taken 24 hours after dose and prior to 
subsequent dose 
CBC 
Complete blood count 
CEA 
Carcinoembryonic antigen 
CI 
Confidence interval 
cm 
Centimeter 
CNS 
Central nervous system 
CR 
Complete response 
CRF 
Case report form 
CSF 
Cerebrospinal fluid 
CSR 
Clinical study report 
CT 
Computed tomography 
ctDNA 
Circulating tumor DNA 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
Coefficient of variation 
DLT 
Dose-limiting toxicity 
DNA 
Deoxyribonucleic acid 
DOR 
Duration of response 


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Abbreviation 
Definition 
ECOG 
Eastern Cooperative Oncology Group 
ECG 
Electrocardiogram 
FDA 
Food and Drug Administration 
g 
Gram 
HBC 
hepatobiliary cancer 
ICH 
International Conference on Harmonisation 
IDH1 
Isocitrate dehydrogenase 1 
IDH2 
Isocitrate dehydrogenase 2 
IHCC 
intrahepatic cholangiocarcinoma 
IRB 
Institutional Review Board 
IWG 
International Working Group 
IV 
Intravenous 
kg 
Kilogram 
KM 
Kaplan Meier 
L 
Liter 
LDH 
Lactic dehydrogenase 
m2 
Square meter 
MedDRA 
Medical Dictionary for Regulatory Activities 
mEq 
Milliequivalence 
mg 
Milligram 
mL 
Milliliter 
mm 
Millimeter 
mm3 
Cubic millimeter 
MR 
Minor response 
MRI 
Magnetic resonance imaging 
MRS 
Magnetic resonance spectroscopy 
MTD 
Maximum tolerated dose 
N 
Number 
NOS 
Not otherwise specified 
ORR 
Overall response rate 
OS 
Overall survival 
PD 
Progressive disease  
% 
Percent 
PFS 
Progression-free survival 
pH 
Hydrogen ion concentration 


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Abbreviation 
Definition 
PK 
Pharmacokinetic 
PR 
Partial response  
PT 
Preferred term 
PTT 
Partial thromboplastin time 
QD 
quaque die/ once daily 
QOL 
Quality of life 
QT 
Interval between Q and T waves 
QTc 
Corrected interval between Q and T waves 
RBC 
Red blood cell (count) 
Rel Day 
Relative study day 
RP2D 
Recommended phase 2 dose 
RTF 
Rich text format 
SAE 
Serious adverse events 
SAP 
Statistical analysis plan 
SC 
Subcutaneous 
SD 
Stable disease or Standard deviation 
SI 
International System of Units 
SOC 
System organ class 
T1/2 
Half-life 
Tmax 
Time to maximum plasma concentration 
TT 
Treatment termination 
TTP 
Time to progression 
TTR 
Time to response 
ULN 
Upper limit of normal 
Vdss 
Volume of distribution at steady state 
WBC 
White blood cell (count) 
WHO 
World Health Organization 
 


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1. 
INTRODUCTION AND OBJECTIVES 
1.1. 
Introduction 
Isocitrate dehydrogenase 1 (IDH1) and isocitrate dehydrogenase 2 (IDH2) mutations in cancer 
result in abnormal hypermethylation of histones and DNA and suppression of normal cellular 
differentiation. The metabolic enzyme IDH1 catalyzes the oxidative decarboxylation of isocitrate 
to α-ketoglutarate (α-KG). In both hematologic and solid tumor malignancies, IDH1 mutations 
lead to aberrant accumulation of (R)-2-hydroxyglutarate (2-HG). 2-HG has been proposed to act 
as an “oncometabolite” that has pleotropic effects on tumorigenesis. Excess production of 2-HG 
has been shown to inhibit α-KG-dependent enzymes involved in epigenetic regulation, collagen 
synthesis, and cell signaling, thereby leading to a block in normal differentiation of progenitor 
cells and the subsequent development of cancer (Gross et al, 2010; Cairns et al, 2019; Losman et 
al, 2013). Therefore, inhibition of mutated IDH1 in tumor cells and the concomitant decrease in 
2-HG production is expected to restore normal cellular differentiation and provide therapeutic 
benefit in IDH1-mutated cancers. 
The identification of frequent mutations in the IDH1 and IDH2 genes in human cancers 
including glioma, hepatocellular carcinomas, chondrosarcomas and intrahepatic 
cholangiocarcinoma (IHCC) has provided novel therapeutic targets in these diseases (Yan et al, 
2009; Amary et al, 2011; Wang et al, 2013; Lee et al, 2017). IDH mutation specific inhibitors 
have been shown to reduce aberrantly elevated levels of the oncometabolite 2-HG, resulting in 
antitumor efficacy in preclinical models (Rohle et al, 2013; Saha et al, 2014). Clinical 
investigation in patients with IHCC, gliomas and chondrosarcomas are ongoing with several 
other IDH1 inhibitors. A comparable IDH1 inhibitor, ivosidenib has published preliminary data 
regarding clinical activity in gliomas, chondrosarcomas and IHCC (Tap et al, 2016; Ishii et al, 
2017; Mellinghoff et al, 2017).  
1.2. 
Study Objectives 
This statistical analysis plan (SAP) is designed to outline the methods to be used in the analysis 
of study data in order to answer the study objectives.  Populations for analysis, data handling 
rules, statistical methods, and formats for data presentation are provided.  The statistical analyses 
and summary tabulations described in this SAP will provide the basis for the results sections of 
the clinical study report (CSR) for this trial. 
This SAP will also outline any differences in the currently planned analytical objectives relative 
to those planned in the study protocol. 
Primary Objectives 


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Phase 1b: Evaluate the safety and tolerability of FT-2102 as monotherapy and confirm the dose 
to be further examined in expansion cohorts as monotherapy and combination therapy. 
Phase 2: Evaluate the clinical activity of FT-2102 as monotherapy or in combination in patients 
with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation. 
Secondary Objectives 
Phase 1b:  
• Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-
cancer agents 
• Evaluate the clinical activity of FT-2102 as a single agent or in combination in 
patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation 
Phase 2: 
• Evaluate the safety of FT-2102 administered as monotherapy and in combination with 
other anti-cancer agents in patients with glioma, HBC, chondrosarcoma, and IHCC 
harboring an IDH1 mutation 
• Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-
cancer agents 
• Evaluate additional measures of antitumor activity of FT-2102 as monotherapy or in 
combination with other anti-cancer agents 
Exploratory Objectives 
• Evaluate potential biomarkers of response, resistance, and/or safety 
• Evaluate pharmacodynamic and PK/pharmacodynamic relationship of FT-2102 as 
monotherapy and in combination with other anti-cancer agents 
• Evaluate the biological effects of FT-2102 on tumor tissue, including tumor cells, 
CSF, immune cells, and vasculature  
• Evaluate the biological effects of FT-2102 on tumor tissue, including tumor cells, 
CSF, immune cells, and vasculature  
• Assess IDH1 mutations in ctDNA and correlate with mutations in tumor tissues 


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• Evaluate the health-related quality of life (QOL)  
1.3. 
Study Endpoints 
Primary Endpoint 
Phase 1b: DLTs (Safety Lead-in Periods), adverse event (AEs), and safety laboratory values  
Phase 2: Objective response rate (ORR), as determined by applicable disease criteria, for 
disease-specific cohorts 
Secondary Endpoints 
• AEs, and safety laboratory values (Phase 2)  
• ORR (Phase 1b only) 
• PFS, defined as the time from the first dose to disease progression as determined by 
applicable disease criteria or death due to any cause, whichever is sooner 
• Time to progression (TTP), defined as the time from start of treatment until disease 
specified progression 
• Duration of response (DOR), defined as the time from the first response to 
documented disease progression as determined by applicable disease criteria 
• OS, defined as the time from the first dose to death due to any cause  
• Time to Response (TTR), defined as the time from first dose to first response 
• AEs and abnormal laboratory findings 
• PK parameters derived from plasma/cerebrospinal fluid (CSF) FT-2102 
concentrations 
Exploratory Endpoints 
• Pharacodynamic and PK/pharmacodynamic in relationship with clinical safety and 
clinical activity 


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• Changes in 2-hyroxygluterate (2-HG levels) (pharmacodynamic, biomarker) in 
plasma and tumor tissue (1H magnetic resonance spectroscopy (MRS) and CSF in 
intracranial gliomas and tumor biopsies for other tumors) 
• Characterization of biological effects of FT-2102 on tumor biopsies 
• Cancer-associated mutations and/or genetic alterations 
• IDH1 mutation in ctDNA 
• Health-related QOL patient-reported questionnaire (EQ5D) 
1.4. 
Study Design 
1.4.1. 
Synopsis of Study Design 
This is a multicenter, Phase 1b/2, open-label, multiple-cohort study examining the efficacy and 
safety of FT-2102 as a single agent or in combination for the treatment of patients with advanced 
solid tumors and gliomas with IDH1 R132X mutations.   
The study is comprised of 5 cohorts, where four cohorts represent different types of solid tumors 
and one represents gliomas.  Within three of the solid tumor and the glioma cohorts, initially FT-
2102 will be administered in a single agent regimen.  Each cohort is designed as an independent 
Simon 2-stage study.  If, within a cohort, the Simon 2-stage stops either at the interim analysis 
for futility or if the final analysis fails to accept the alternative hypothesis, dosing with FT-2102 
in combination with other therapies (specific to the disease under study) may commence in a 
new Simon 2-Stage assessment. Cohort 5 is comprised of “other non-central nervous system 
(CNS) solid tumors” for patients harboring an IDH-R132X mutation (i.e. other solid tumors that 
do not fit into the first 4 cohorts).  This cohort is purely exploratory, and thus is not designed as a 
Simon 2-stage.  There are no plans to administer any combination therapy for patients enrolled 
into cohort 5; it is designed as a single agent therapy cohort only. 
The Phase 1b part of the study is a safety-lead in, 3+3 study design in which the dose of 150 mg 
BID, which has been selected as the Phase 2 dose in a concurrent study in AML (2102-HEM-
101) will be evaluated for safety.  Once the Phase 1b portion is complete and the recommended 
Phase 2 dose (RP2D) has been selected for a cohort, the Phase 2 portion of the study may 
commence.  The RP2D may differ for each cohort.  Patients in the Phase 1b portion who were 
dosed at the RP2D dose level may contribute to the Phase 2 Simon 2-Stage evaluation. 
An overview of the study is depicted in Section 12 of the SAP.  


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1.4.2. 
Randomization Methodology 
N/A; study is open-label. 
1.4.3. 
Stopping Rules and Unblinding 
Unblinding is not applicable as study is open label.  Several stopping rules apply, as there are 
Simon 2-Stage study designs within each cohort. 
1.4.4. 
Study Procedures 
The schedule of assessments is outlined in the study protocol, Tables 2-8.  Refer to the study 
protocol for these details.
1.4.5. 
Efficacy, Pharmacokinetic, Pharmacodynamic and Safety Parameters 
1.4.5.1. 
Efficacy Parameters 
Objective Response Rate is defined as follows: 
• Glioma: the proportion of patients with a best response of CR, PR or MR 
(LGG) 
• HBC: the proportion of patients with a best response of CR or PR 
• Chondrosarcoma: the proportion of patients with a best response of CR or PR 
• Cholangiocarcinoma: the proportion of patients with a best response of CR or 
PR  
Best overall response (BOR): BOR is the best response achieved by the patient at any 
time while on study. 
Progression Free Survival (PFS): defined as the time from the date of the first dose to the 
date of disease progression as determined by applicable disease criteria or death due to 
any cause, whichever is sooner.  If a patient withdraws from the study prior to an event 
occurring, the patient will be censored at the date of the last response evaluation. 
Time to Progression (TTP): defined as the time from the date of the first dose to the date 
of disease progression as determined by applicable disease criteria.  If progression does 
not occur while on study, the patient will be censored at the date of the last response 
evaluation. 


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Duration of Response (DOR): defined as the time from the date of the first response to 
the date of the documented disease progression as determined by applicable disease 
criteria.  If progression does not occur while on study, the patient will be censored at the 
date of the last response evaluation.  This will only be calculated for those patients who 
have a best response of MR or better. 
Overall Survival (OS): defined as the time from the date of the first dose to the date of 
death due to any cause.  If death is not recorded, the patient will be censored at the date 
of the last known alive. 
Time to Response (TTR): defined as the time from the date of first dose to the date of 
first CR, PR or MR response. This will only be calculated for those patients who have a 
best response of MR or better. 
Best percent change in tumor burden while on study: Maximum percentage reduction or 
minimum percentage increase at a single time point of the patient’s tumor burden post 
first dose of study drug. 
Time on treatment: Time from the date of first FT-2102 dose to the date of  the last FT-
2102 dose. 
Health-related QOL patient-reported questionnaire (EQ5D): Change from baseline for 
each dimension and overall, number of patients reporting each score for each dimension 
and overall, and number of patients reporting some problems on each dimension. 
1.4.5.2. 
Pharmacokinetic Parameters 
Blood samples for determination of FT-2102 pharmacokinetics are to be collected as 
outlined in the protocol.  Pharmacokinetic parameters to be derived from FT-2102 plasma 
concentrations collected in Phase 1b (Stage 1) include minimum plasma concentration 
(Cmin), maximum plasma concentration (Cmax), time to maximum plasma concentration 
(Tmax), and area under the concentration versus time curve (AUC).  
1.4.5.3. 
Pharmacodynamic Parameters 
Pharacodynamic assessments being performed in this study include: 
• Changes in 2-hyroxygluterate (2-HG) levels (PD, biomarker) in plasma, urine and 
tumor tissue (1H magnetic resonance spectroscopy (MRS)) and CSF (if available) 
in intracranial gliomas and tumor biopsies for other tumors) 
• Characterization of biological effects of FT-2102 on tumor biopsies 
• Cancer-associated mutations and/or genetic alterations 
• IDH1 mutation in ctDNA 


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1.4.5.4. 
Safety Parameters 
DLTs will be assessed for each dose evaluated in the Phase 1b phase. 
The maximum tolerated dose (MTD) will be evaluated. 
The RP2D will be determined for each cohort based on both safety and efficacy. 
Safety evaluations performed during the study included physical examinations, 
measurement of vital signs, 12-lead electrocardiograms, clinical laboratory evaluations 
including hematology, serum chemistry, and urinalysis, and monitoring of adverse events 
and concomitant medications. 
 


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2. 
PATIENT POPULATION 
2.1. 
Analysis Sets 
Dose-Limiting Toxicity-Evaluable Analysis Set 
The DLT-Evaluable Analysis Set is defined as all patients in the Safety Lead-in Periods 
(single- agent FT-2102, combination FT-2102 + 5-azacitidine, combination FT-2102 + 
GemCis and combination FT-2102 + PD-1 inhibitor) who either experienced a DLT 
during Cycle 1 or completed at least 75% of the prescribed Cycle 1 dose. This analysis 
set will be used to assess the tolerability of FT-2102. 
Safety Analysis Set 
The Safety Analysis Set is defined as all patients who received any amount of study 
drug(s) (FT-2102 and combination agents, if appropriate).  
This analysis set will be the primary analysis set for all safety endpoints, excluding DLT 
evaluation. Safety analysis will be by cohort and by treatment within cohort if more than 
1 dose or dosing combination are initiated for a particular indication cohort. 
Response-Evaluable Analysis Set 
The Response-Evaluable Analysis Set is defined as all patients with measurable disease 
at baseline are included in the Safety Analysis Set and had at least 1 post-baseline 
response assessment or discontinued the treatment phase due to disease progression 
(including death caused by disease progression) within 8 weeks (+2-week window) of the 
first dose of study treatment. This analysis set will be the primary analysis set for efficacy 
endpoints. All response evaluations will be by cohort, and by treatment within cohort if 
more than 1 doses or dosing combinations are initiated for a particular indication cohort. 
Pharmacokinetics Analysis Set 
The PK analysis set is defined as patients from Stage 1 who have received at least one 
dose of FT-2102 and for whom it is possible to calculate at least one primary PK 
parameter (e.g. Cmax, AUClast). 
Pharmacodynamics Analysis Set 
The Pharmacodynamic analysis set is defined as all patients who received at least one 
dose of FT-2102 and have completed at least one pharmacodynamic assessment.  
 


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2.2. 
Protocol Violations 
Major protocol violations, as determined by a de-identified review of the data, may result 
in the removal of a patient’s data from the Response Evaluable population.  The Sponsor 
will be responsible for producing the final protocol violation file (formatted as a 
Microsoft Excel file), this file will include a description of the protocol violation and 
clearly identify whether this violation warrants exclusion from the Response Evaluable 
population.  This file will be finalized prior to database lock. 
All protocol violations will be presented in a data listing. 


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3. 
GENERAL STATISTICAL METHODS 
3.1. 
Sample Size Justification 
This study will enroll up to approximately 200 patients.  
A single-agent Safety Lead-in Period will be implemented that may enroll approximately 
12 patients, which includes approximately 6 patients with glioma and 6 patients with 
solid tumors. Following successful completion of the Safety Lead-in Period, the study 
will then enroll 4 disease-specific cohorts examining FT-2102 as either a single agent or 
in combination. These cohorts include Cohort 1 (glioma) with 16-46 patients; Cohort 2 
(HBC) with 21-78 patients; Cohort 3 (chondrosarcoma) with 16-46 patients; and Cohort 4 
(IHCC) with 21-78 patients.  There will be a fifth cohort of R132X IDH1 mutant solid 
tumors, non-CNS with up to 6 patients, single-agent only. 
Cohort 1a, Cohort 2a, Cohort 3a (single-agent FT-2102) 
Cohorts, 1a, 2a and 3a will employ an optimal Simon’s 2-Stage design with a 1-sided 
alpha of 0.025, power of 80%, null hypothesis of 5% and alternative hypothesis of 25%. 
Stage 1 of these cohorts will evaluate 8 patients for efficacy over 4 treatment cycles; if 
there are 1 or more responses, Stage 2 will initiate with additional 15 patients. If there are 
4 or more responses out of the total 23 patients, the null hypothesis of 5% will be 
rejected. If there is no response in Stage 1 with single-agent FT-2102, or if the null 
hypothesis is not rejected at the end of Stage 2, combination therapy may be evaluated.  
Cohort 4a (single-agent FT-2102) 
Cohort 4a employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, 
power of 80%, null hypothesis of 8% and alternative hypothesis of 35%. Stage 1 will 
evaluate 8 patients and if there are 2 or more responses Stage 2 will initiate with 
additional 14 patients. If there are 5 or more responses out of the total 22 patients, the 
null hypothesis of 8% will be rejected.  If there is 0 or 1 response in Stage 1 with single-
agent FT-2102, or if the null hypothesis is not rejected at the end of Stage 2, combination 
may be evaluated. 
Combination Cohorts (1b, 2b, 3b, 4b)  
If there is no response in Stage 1 with single-agent FT-2102, combination cohorts may be 
examined. 
Cohort 1b and Cohort 3b 
For Cohorts 1b and 3b (combination therapy), an optimal Simon’s 2-Stage design will be 
implemented with a 1-sided alpha of 0.025, 80% power, with a null hypothesis of 5% and 
alternative hypothesis of 25%. Stage 1 of each cohort will evaluate 8 patients for efficacy 
over 4 treatment cycles; if there are 1 or more responses, Stage 2 will initiate with 


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additional 15 patients. If there are 4 or more responses out of the total 23 patients, the 
null hypothesis of 5% will be rejected.  
Cohort 2b  
Cohort 2b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, 
power of 80%, null hypothesis of 20% and alternative hypothesis of 40%. Stage 1 will 
evaluate 13 patients for efficacy; if there are 4 or more responses Stage 2 will initiate 
with an additional 42 patients. If there are 17 or more responses out of the total 55 
patients, the null hypothesis of 20% will be rejected.   
Cohort 4b  
Cohort 4b employs an optimal Simon’s 2-Stage design with a 1-sided alpha of 0.025, 
power of 80%, null hypothesis of 20% and alternative hypothesis of 40%. Stage 1 will 
evaluate 13 patients and if there are 4 or more responses Stage 2 will initiate with 
additional 42 patients. If there are 17 or more responses out of the total 55 patients, the 
null hypothesis of 20% will be rejected.   
Cohort 5 
Cohort 5, due to the diverse population, this is an exploratory cohort without pre-defined 
efficacy/futility determinations (n=6). 
3.2. 
General Methods 
Data will be summarized in the following groupings: 
Group Description 
Table Column Header 
Cohort 1A: Glioma FT-2102 
C1A Glioma SA 
Cohort 1B: Glioma FT-2102 + Azacitidine 
C1B Glioma Combo 
Cohort 1: Glioma 
C1 Glioma Overall 
Cohort 2A: HBC FT-2102 
C2A HBC SA 
Cohort 2B: HBC FT-2102 + Nivolumab 
C2B HBC Combo 
Cohort 2: HBC 
C2 HBC Overall 
Cohort 3A: Chondrosarcoma FT-2102 
C3A Chondro SA 
Cohort 3B: Chondrosarcoma FT-2102 + 
Azacitidine 
C3B Chondro Combo 


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Cohort 3: Chondrosarcoma 
C3 Chondro Overall 
Cohort 4A: Cholangiocarcinoma FT-2102 
C4A Cholangio SA 
Cohort 4B: Cholangiocarcinoma FT-2102 
+ Gemcitibine + Cisplatin 
C4B Cholangio Combo 
Cohort 4: Cholangiocarcinoma 
C4 Cholangio Overall 
Cohort 5: Other Solid Tumors FT-2102 
C5 Other Tumors SA 
All data listings that contain an evaluation date will contain a relative study day (Rel 
Day).  Pre-treatment and on-treatment study days are numbered relative to the day of the 
first dose of study medication which is designated as Day 1.  The preceding day is 
Day -1, the day before that is Day -2, etc.   
All output will be incorporated into Microsoft Word files, sorted and labeled according to 
the International Conference on Harmonisation (ICH) recommendations, and formatted to 
the appropriate page size(s). 
Tabulations will be produced for appropriate demographic, baseline, efficacy, 
pharmacokinetic, and safety parameters.  For categorical variables, summary tabulations 
of the number and percentage of patients within each category (with a category for 
missing data) of the parameter will be presented.  For continuous variables, the number of 
patients, mean, median, standard deviation (SD), minimum, and maximum values will be 
presented.  Time-to-event data will be summarized using Kaplan-Meier methodology 
using 25th, 50th (median), and 75th percentiles with associated 2-sided 95% confidence 
intervals, as well as percentage of censored observations. Minimum and maximum values 
will be presented to the same decimal precision as the raw values, mean and median 
values to one more, and the standard deviation to two more decimal places that the raw 
values. And for categorical: all percentages will be presented to one decimal place.   
Formal statistical hypothesis testing will be performed on overall response rate with all 
tests conducted at the 1-sided, 0.025 level of significance.  Summary statistics will be 
presented, as well as confidence intervals on selected parameters, as described in the 
sections below. 
Aside from the primary endpoint of overall response rate, other data analyses are 
descriptive and will be summarized using descriptive statistics noted above. 
Relevant Output 
Listing 16.2.0.1 
Treatment Codes Applicable to Tables and Listings 
3.3. 
Computing Environment 
All descriptive statistical analyses will be performed using SAS statistical software 
Version 9.3 or higher, unless otherwise noted.  Medical history and adverse events will 


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be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 
21.0.  Concomitant medications and prior therapies will be coded using the World Health 
Organization (WHO) Drug Dictionary Version Global B3 format March 2018. 
3.4. 
Baseline Definitions 
For all analyses, baseline will be defined as the most recent measurement prior to the first 
administration of study drug. 
3.5. 
Methods of Pooling Data 
Data will be pooled for the Phase 1b and Phase 2 patients who are in the EE Population 
who are dosed at the same level for purposes of the test of the primary endpoint and other 
efficacy analyses. 
Data for each cohort will be pooled for patients within treatment regimen.  Data from all 
study sites and countries will be pooled together. 
3.6. 
Adjustments for Covariates 
No formal statistical analyses that adjust for possible covariate effects are planned.  Ad 
hoc analyses examining covariate effects may be performed. 
3.7. 
Multiple Comparisons/Multiplicity 
No adjustments to the overall alpha of this study have been made.  Each cohort is 
independent and will be tested with a single primary endpoint at the 1-sided 0.025 level, 
so the control of false positives is maintained within each cohort. 
3.8. 
Subpopulations 
Selected analyses will be performed by subgroup.  Some subgroups only apply to 
selected cohorts.  The following subgroups will be examined: 
• Gender 
• Caucasian vs. other races 
• Asian vs. other races (Cohorts 2 and 4 only) 
• Baseline ECOG 0/1 vs 2 
• Baseline Child-Pugh Score (Cohorts 2 and 4 only) 
• Age (18-40, 41-59, ≥60) 
• Prior surgery only vs. prior surgery and other anti-cancer therapies 


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• Number of prior regimens (1, 2, 3, >3) 
• Prior IDH1 therapy (yes, no) (combination therapy patients only- Cohort 1b, 2b, 
3b, 4b) 
• Prior temozolomide (yes, no) (Cohort 1 only) 
• Prior procarbazine/CCNU/vincristine (yes, no) (Cohort 1 only) 
• Prior radiation therapy (yes, no) (Cohort 1 only) 
• Baseline steroids (yes, no) (Cohort 1 only) 
• Baseline tumor grade (I or II, III, IV) 
• Baseline tumor grade (Stage I, II, or III vs. Stage IV) 
• Hepatitis B positive (yes, no) (Cohort 2 only) 
• Hepatitis C positive (yes, no) (Cohort 2 only) 
• Hepatitis B or C positive (yes, no) (Cohort 2 only) 
• Prior gemcitabine-based therapy (yes, no) (Cohorts 2 and 4 only) 
• Prior nivolumab or pembrolizumab therapy (yes, no) (Cohort 2) 
• Cancer diagnosis (hepatocellular carcinoma, gallbladder carcinoma, IHCC, 
extrahepatic cholangiocarcinoma, biliary tumor NOS) (Cohort 2 only) 
• Glioma diagnosis (Cohort 1 only).  Diagnosis subgroupings to be determined 
based on the data from enrolled patients. 
• Chondrosarcoma diagnosis (differentiated, mesenchymal, clear cell, unknown/ 
other) (Cohort 3 only) 
•  IDH1 mutation subtype (R132H, R132C, other R132 subtypes) 
• Co-mutations.  Subgroupings to be determined based on the data from enrolled 
patients. 
• Responder status (best overall response of MR or better vs. non-responder) 
• Tumor imaging method (enhancing, non-enhancing).  Enhancing = yes if: 
Screening imaging assessment was performed via T1 MRI post contrast.  
Otherwise enhancing = no.   


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3.9. 
Withdrawals, Dropouts, Loss to Follow-up 
Patients who drop out from Phase 1b who are not able to be included in the DLT 
evaluable population will be replaced to fill the required numbers of patients to evaluate 
each dose level per the study protocol. 
As the sample size for Phase 2 is based on the Response Evaluable Population, if patients 
drop out before they become evaluable for Response they will be replaced. 
3.10. 
Missing, Unused, and Spurious Data 
In general, there will be no substitutions made to accommodate missing data points.  All 
data recorded on the case report form will be included in data listings that will 
accompany the clinical study report. 
Handling of values listed as BLQ for PK and PD data is described in Section 4.4. 
Missing partial date of adverse events or concomitant medications will be imputed for 
purposes of classification as treatment emergent or concomitant, but in data listings the 
reported date, not the imputed date, will be presented.  In cases where a date part is 
missing, a relday will not be calculated and presented in the listing; the relday will be 
missing. 
Adverse events 
When tabulating adverse event data, partial dates will be handled as follows.  If the day 
of the month is missing, the onset day will be set to the first day of the month unless it is 
the same month and year as study treatment.  In this case, in order to conservatively 
report the event as treatment-emergent, the onset date will be assumed to be the date of 
treatment.  If the onset day and month are both missing, the day and month will be 
assumed to be January 1, unless the event occurred in the same year as the study 
treatment.  In this case, the event onset will be coded to the day of treatment in order to 
conservatively report the event as treatment-emergent.  A missing onset date will be 
coded as the day of treatment. 
Concomitant medications 
For records with a missing medication start and/or stop date, the following procedure will 
be employed for use in determining whether the medication is prior or concomitant: 
• Medication start dates with a missing day and non-missing month will be 
assumed to occur on the first day of the non-missing month, except for 
medications occurring in the first month of dosing, in which case the date will 
be the first day of dosing. 
• Medication start dates with missing month will be assumed to occur on the 
first day of the non-missing year (i.e., January 1), except for medications 


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occurring in the first year of dosing, in which case the date will be the first 
day of dosing.  
• Medication start year is unknown, the date will not be imputed.  
• Medications that are not ongoing and have a medication stop date with a 
missing day and non-missing month will be assumed to occur on the last day 
of the non-missing month. 
• Medications that are not ongoing and have a medication stop date with a 
missing month will be assumed to occur on the last day of the non-missing 
year (ie, December 31). 
• Medications that are not ongoing and have a medication stop date with a 
missing year will be assumed to occur on the first day of dosing. 
  
3.11. 
Visit Windows 
It is expected that all visits should occur according to the protocol schedule.  All data will 
be tabulated per the evaluation visit as recorded on the CRF even if the assessment is 
outside of the visit window.  In data listings, the relative day of all dates will be 
presented. 
3.12. 
Interim Analyses 
Within each cohort, Optimal Simon’s 2-Stage designs are employed for both the single 
agent treatment and also for combination treatment.  There are different hypotheses being 
tested for each cohort, and thus there are different stopping rules for the cohorts, which 
are described below.  All of the following interim analyses are to be conducted on the 
Response Evaluable Set. 
Combination therapy in cohorts 1-4 may also be examined in the event that the single 
agent cohort passes the futility analysis and the enrollment in the single agent cohort is 
completed following review by the SRC (below).  
Cohort 1a, Cohort 2a, Cohort 3a (single-agent FT-2102) 
Cohorts 1a, 2a, and 3a will employ an optimal Simon’s 2-Stage design testing a null 
hypothesis of 5% response versus alternative hypothesis of 25% response. Stage 1 will 
evaluate 8 patients for efficacy over 4 treatment cycles; if there are 1 or more responses, 
Stage 2 will initiate with additional 15 patients. If there is no response in Stage 1 with 
single-agent FT-2102, combination therapy will be evaluated (Cohorts 1b, 2b, 3b).  
Cohort 4a (single-agent FT-2102) 


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Cohort 4a employs an optimal Simon’s 2-Stage design testing a null hypothesis of 8% 
response versus the alternative hypothesis of 35% response. Stage 1 will evaluate 8 
patients and if there are 2 or more responses Stage 2 will initiate with additional 14 
patients. If there is 0 or 1 response in Stage 1 with single-agent FT-2102, combination 
therapy will be evaluated (Cohort 4b). 
Cohort 1b and Cohort 3b 
For Cohorts 1b and 3b (combination therapy), an optimal Simon’s 2-Stage design will be 
implemented to test a null hypothesis of 5% response versus the alternative hypothesis of 
25% response. Stage 1 of each cohort will evaluate 8 patients for efficacy over 
4 treatment cycles; if there are 1 or more responses, Stage 2 will initiate with additional 
15 patients.  If there is no response in Stage 1, enrollment will cease, and the null 
hypothesis will fail to be rejected. 
Cohorts 2b and 4b 
Cohorts 2b and 4b employ an optimal Simon’s 2-Stage design to test a null hypothesis of 
20% response versus alternative hypothesis of 40% response. Stage 1 will evaluate 13 
patients for efficacy; if there are 4 or more responses Stage 2 will initiate with an 
additional 42 patients. If there are 3 or fewer responses, enrollment will cease, and the 
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4. 
STUDY ANALYSES 
4.1. 
Patient Disposition 
Patient disposition will be tabulated and include the number screened, the number treated 
in total, the number dosed with FT-2102, the number dosed with azacitidine, nivolumab, 
or gemcitabine/cisplatin, the number in each patient population for analysis, the number 
of patients who are ongoing in treatment FT-2102 or, if they have ceased treatment with 
FT-2102, the reason for stopping.  The number of patients who are ongoing in the study 
(whether on treatment or off treatment still in follow up), or if they have ceased study 
participation the reason for stopping participation in the study.  Separate tables will be 
run for each cohort and within each cohort, tables will be tabulated by single agent 
therapy and combination therapy. 
A by-patient data listing of study disposition information will be presented by cohort and 
dose level. 
Relevant Output 
Table 14.1.1 
Patient Enrollment and Disposition (Cohort 1) 
Table 14.1.1 
Patient Enrollment and Disposition (Cohort 2) 
Table 14.1.1 
Patient Enrollment and Disposition (Cohort 3) 
Table 14.1.1 
Patient Enrollment and Disposition (Cohort 4) 
Table 14.1.1 
Patient Enrollment and Disposition (Cohort 5) 
 
Listing 16.2.1.1 
Study Completion Status 
Listing 16.2.1.2 
Pre-Screening Consent 
Listing 16.2.1.3 
Enrollment 
Listing 16.2.2.1 
Inclusion and Exclusion Criteria 
Listing 16.2.2.2 
Protocol Violations 
Listing 16.2.3.1 
Analysis Sets 
4.2. 
Demographics and Baseline Disease Characteristics 
Demographics, baseline characteristics, prior anti-cancer therapies, and IDH1 and other 
mutation data, will be summarized for each cohort by treatment regimen for the Safety 
and Response Evaluable Populations using descriptive statistics.   
BMI will be calculated as: weight (kg) / (height (m))2 
Medical history information will be summarized for the Safety Population.  Baseline 
Child-Pugh score and category (A, B, C) will be summarized within the baseline disease 
characteristics table for Cohorts 2 and 4.  Hepatitis B and C status (positive or negative) 
will also be summarized within the baseline disease characteristics table.  No formal 
statistical comparisons will be performed. 


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Medical history data will be coded via MedDRA.  Prior anti-cancer therapies data will be 
coded via WHODrug. 
In summarization of time since initial cancer diagnosis and months since recurrence, if a 
partial date is given in the data, month and day will be imputed as January and 01, 
respectively.  Time since cancer diagnosis and months since recurrence will be derived 
as: informed consent date- date (diagnosis or recurrence) +1. 
All demographic and baseline data for each patient will be provided in data listings.  Prior 
radiotherapy and major surgical tumor resections   will only be listed; they will not be 
summarized.   
Relevant Output 
Table 14.1.2.1a 
Demographics and Baseline Characteristics (Cohort 1, Response 
Evaluable Population) 
Table 14.1.2.1b 
Demographics and Baseline Characteristics (Cohort 2, Response 
Evaluable Population) 
Table 14.1.2.1c 
Demographics and Baseline Characteristics (Cohort 3, Response 
Evaluable Population) 
Table 14.1.2.1d 
Demographics and Baseline Characteristics (Cohort 4, Response 
Evaluable Population) 
Table 14.1.2.1e 
Demographics and Baseline Characteristics (Cohort 5, Response 
Evaluable Population) 
 
Table 14.1.2.2a 
Demographics and Baseline Characteristics (Cohort 1, Safety 
Population) 
Table 14.1.2.2b 
Demographics and Baseline Characteristics (Cohort 2, Safety 
Population) 
Table 14.1.2.2c 
Demographics and Baseline Characteristics (Cohort 3, Safety 
Population) 
Table 14.1.2.2d 
Demographics and Baseline Characteristics (Cohort 4, Safety 
Population) 
Table 14.1.2.2e 
Demographics and Baseline Characteristics (Cohort 5, Safety 
Population) 
 
Table 14.1.3.1a 
Baseline Disease Characteristics (Cohort 1, Response Evaluable 
Population) 
Table 14.1.3.1b 
Baseline Disease Characteristics (Cohort 2, Response Evaluable 
Population) 
Table 14.1.3.1c 
Baseline Disease Characteristics (Cohort 3, Response Evaluable 
Population) 
Table 14.1.3.1d 
Baseline Disease Characteristics (Cohort 4, Response Evaluable 
Population) 


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Table 14.1.3.1e 
Baseline Disease Characteristics (Cohort 5, Response Evaluable 
Population) 
 
Table 14.1.3.2a 
Baseline Disease Characteristics (Cohort 1, Safety Population) 
Table 14.1.3.2b 
Baseline Disease Characteristics (Cohort 2, Safety Population) 
Table 14.1.3.2c 
Baseline Disease Characteristics (Cohort 3, Safety Population) 
Table 14.1.3.2d 
Baseline Disease Characteristics (Cohort 4, Safety Population) 
Table 14.1.3.2e 
Baseline Disease Characteristics (Cohort 5, Safety Population) 
 
Table 14.1.4.1a 
IDH1 and Other Mutations (Cohort 1, Response Evaluable 
Population) 
Table 14.1.4.1b 
IDH1 and Other Mutations (Cohort 2, Response Evaluable 
Population) 
Table 14.1.4.1c 
IDH1 and Other Mutations (Cohort 3, Response Evaluable 
Population) 
Table 14.1.4.1d 
IDH1 and Other Mutations (Cohort 4, Response Evaluable 
Population) 
Table 14.1.4.1e 
IDH1 and Other Mutations (Cohort 5, Response Evaluable 
Population) 
 
Table 14.1.4.2a 
IDH1 and Other Mutations (Cohort 1, Safety Population) 
Table 14.1.4.2b 
IDH1 and Other Mutations (Cohort 2, Safety Population) 
Table 14.1.4.2c 
IDH1 and Other Mutations (Cohort 3, Safety Population) 
Table 14.1.4.2d 
IDH1 and Other Mutations (Cohort 4, Safety Population) 
Table 14.1.4.2e 
IDH1 and Other Mutations (Cohort 5, Safety Population) 
 
Table 14.1.5.1a 
Prior Therapies (Cohort 1, Response Evaluable Population) 
Table 14.1.5.1b 
Prior Therapies (Cohort 2, Response Evaluable Population) 
Table 14.1.5.1c 
Prior Therapies (Cohort 3, Response Evaluable Population) 
Table 14.1.5.1d 
Prior Therapies (Cohort 4, Response Evaluable Population) 
Table 14.1.5.1e 
Prior Therapies (Cohort 5, Response Evaluable Population) 
 
Table 14.1.5.2a 
Prior Therapies (Cohort 1, Safety Population) 
Table 14.1.5.2b 
Prior Therapies (Cohort 2, Safety Population) 
Table 14.1.5.2c 
Prior Therapies (Cohort 3, Safety Population) 
Table 14.1.5.2d 
Prior Therapies (Cohort 4, Safety Population) 
Table 14.1.5.2e 
Prior Therapies (Cohort 5, Safety Population) 
 
Table 14.1.6a 
Medical History (Cohort 1, Safety Population) 
Table 14.1.6b 
Medical History (Cohort 2, Safety Population) 
Table 14.1.6c 
Medical History (Cohort 3, Safety Population) 


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Table 14.1.6d 
Medical History (Cohort 4, Safety Population) 
Table 14.1.6e 
Medical History (Cohort 5, Safety Population) 
 
Listing 16.2.4.1 
Demographics and Baseline Information 
Listing 16.2.4.2 
Baseline Disease Data and Cancer Diagnosis 
Listing 16.2.4.3 
IDH1 Mutation and Other Mutations 
Listing 16.2.4.4 
Medical History 
Listing 16.2.4.5 
Prior Anti-Cancer Therapies 
Listing 16.2.4.6 
Prior Radiotherapy 
Listing 16.2.4.7 
Major Surgical Tumor Resections 
Listing 16.2.4.8 
Child-Pugh Score 
Listing 16.2.4.9 
Hepatitis B and C 
Listing 16.2.4.10 
Archival Tumor Tissue 
 
4.3. 
Efficacy Evaluations 
4.3.1. 
Disease Response and Survival Analyses 
In general, efficacy analyses will be conducted using the Response Evaluable population, 
with the exception of overall survival and the figure of time on treatment, which will be 
conducted on both the Response Evaluable and the Safety Population. 
Best overall response and overall response rate will be summarized by cohort and 
treatment regimen (single agent or combination therapy) in the disease response 
assessment table.  Disease response assessment will be further examined by subgroups, as 
described in Section 3.8.  PFS, TTP, DOR, and TTR will be summarized by cohort and 
treatment regimen in another table.  OS will be summarized for both the Response 
Evaluable and the Safety populations.   
Time to event endpoints (OS, PFS, DOR) will be expressed as the number of weeks from 
first dose to the event and will be analyzed using Kaplan-Meier (KM) methods for each 
cohort. Censoring for each time to event endpoint is defined in Section 1.4.5.  The 
median time to event will be presented along with the 95% confidence intervals, 1st and 
3rd quartiles, and minimum and maximum values. The estimated probability of OS and 
PFS over time will be plotted as KM curves for each cohort and treatment regimen.  The 
probability of survival for each cohort at 3, 6, 9, and 12 months will also be estimated 
using KM methods. 
A plot of time on treatment (aka “swim plot”) will be created for patients in the Safety 
Population to visualize the time on treatment.  The plot will be color coded by best 
overall response.  Time of first response (earliest response assessment where overall 
response was MR or better) will be annotated on the plot.  Patients who are still receiving 
treatment with FT-2102 will be indicated with arrows at the end of the bar.  Patients who 
are no longer receiving treatment with FT-2102 will have the reason for stopping FT-


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2102 treatment annotated at the end of the bar.  One plot will be created for each cohort 
and treatment regimen. 
A waterfall plot will be produced for the Response Evaluable population to depict the 
best percentage change in the total tumor burden while on treatment.  One bar will 
represent each patient, and they will be sorted by maximum percentage to least 
percentage.  Each bar will be color coded by best overall response.  One plot will be 
created for each cohort and treatment regimen.  Total tumor burden is calculated as the 
sum of the longest diameter of each target lesion for RECIST assessments.  Total tumor 
burden is calculated as the sum of the product of the diameters (longest diameter x 
perpendicular measurement) for all measurable lesions for RANO assessments.  If a 
patient in Cohort 5 is evaluated by Cheson criteria, total tumor burden is calculated as the 
sum of the product diameters (longest diameter x perpendicular measurement) for all 
target lesions.  Percent change for each follow up assessment is then calculated as the 
percent increase or decrease in total tumor burden from the screening imaging 
assessment. 
Serum AFP, CA19-9, CEA are biomarkers indicative of response in Cohorts 2 and 4.  
They are not assessed in other cohorts.  These markers will be summarized descriptively 
for the Response Evaluable population by cohort and visit.  Additionally, box and 
whisker plots will be created for each parameter by cohort, visit, and responder status to 
compare change in responders vs non-responders over time. 
Relevant Output 
Table 14.2.1a 
Disease Response Assessment Overall and by Subgroup (Cohort 1, 
Response Evaluable Population) 
Table 14.2.1b 
Disease Response Assessment Overall and by Subgroup (Cohort 2, 
Response Evaluable Population) 
Table 14.2.1c 
Disease Response Assessment Overall and by Subgroup (Cohort 3, 
Response Evaluable Population) 
Table 14.2.1d 
Disease Response Assessment Overall and by Subgroup (Cohort 4, 
Response Evaluable Population) 
Table 14.2.1e 
Disease Response Assessment Overall and by Subgroup (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.2.1a 
Best Percent Change from Baseline in Tumor Burden (Cohort 1 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2a 
Best Percent Change from Baseline in Tumor Burden (Cohort 1 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1b 
Best Percent Change from Baseline in Tumor Burden (Cohort 2 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2b 
Best Percent Change from Baseline in Tumor Burden (Cohort 2 
Combination Therapy, Response Evaluable Population) 


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Figure 14.2.2.1c 
Best Percent Change from Baseline in Tumor Burden (Cohort 3 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2c 
Best Percent Change from Baseline in Tumor Burden (Cohort 3 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1d 
Best Percent Change from Baseline in Tumor Burden (Cohort 4 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2d 
Best Percent Change from Baseline in Tumor Burden (Cohort 4 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1e 
Best Percent Change from Baseline in Tumor Burden (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.3.1a 
Time on Treatment (Cohort 1 Single Agent, Safety Population) 
Figure 14.2.3.2a 
Time on Treatment (Cohort 1 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1b 
Time on Treatment (Cohort 2 Single Agent, Safety Population) 
Figure 14.2.3.2b 
Time on Treatment (Cohort 2 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1c 
Time on Treatment (Cohort 3 Single Agent, Safety Population) 
Figure 14.2.3.2c 
Time on Treatment (Cohort 3 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1d 
Time on Treatment (Cohort 4 Single Agent, Safety Population) 
Figure 14.2.3.2d 
Time on Treatment (Cohort 4 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1e 
Time on Treatment (Cohort 5, Safety Population) 
 
Table 14.2.4a 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 1, Response Evaluable 
Population) 
Table 14.2.4b 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 2, Response Evaluable 
Population) 
Table 14.2.4c 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 3, Response Evaluable 
Population) 
Table 14.2.4d 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 4, Response Evaluable 
Population) 
Table 14.2.4e 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 5, Response Evaluable 
Population) 
 


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Table 14.2.5.1 
Overall Survival (Response Evaluable Population) 
Table14.2.5.2 
Overall Survival (Safety Population) 
 
Figure 14.2.5.3a 
Kaplan-Meier Plot of Overall Survival (Cohort 1, Response 
Evaluable Population) 
Figure 14.2.5.3b 
Kaplan-Meier Plot of Overall Survival (Cohort 2, Response 
Evaluable Population) 
Figure 14.2.5.3c 
Kaplan-Meier Plot of Overall Survival (Cohort 3, Response 
Evaluable Population) 
Figure 14.2.5.3d 
Kaplan-Meier Plot of Overall Survival (Cohort 4, Response 
Evaluable Population) 
Figure 14.2.5.3e 
Kaplan-Meier Plot of Overall Survival (Cohort 5, Response 
Evaluable Population) 
 
Figure 14.2.5.4a 
Kaplan-Meier Plot of Overall Survival (Cohort 1, Safety 
Population) 
Figure 14.2.5.4b 
Kaplan-Meier Plot of Overall Survival (Cohort 2, Safety 
Population) 
Figure 14.2.5.4c 
Kaplan-Meier Plot of Overall Survival (Cohort 3, Safety 
Population) 
Figure 14.2.5.4d 
Kaplan-Meier Plot of Overall Survival (Cohort 4, Safety 
Population) 
Figure 14.2.5.4e 
Kaplan-Meier Plot of Overall Survival (Cohort 5, Safety 
Population) 
 
Figure 14.2.5.5a 
Kaplan-Meier Plot of Progression Free Survival (Cohort 1, 
Response Evaluable Population) 
Figure 14.2.5.5b 
Kaplan-Meier Plot of Progression Free Survival (Cohort 2, 
Response Evaluable Population) 
Figure 14.2.5.5c 
Kaplan-Meier Plot of Progression Free Survival (Cohort 3, 
Response Evaluable Population) 
Figure 14.2.5.5d 
Kaplan-Meier Plot of Progression Free Survival (Cohort 4, 
Response Evaluable Population) 
Figure 14.2.5.5e 
Kaplan-Meier Plot of Progression Free Survival (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.5.6a 
Kaplan-Meier Plot of Progression Free Survival (Cohort 1, Safety 
Population) 
Figure 14.2.5.6b 
Kaplan-Meier Plot of Progression Free Survival (Cohort 2, Safety 
Population) 


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Figure 14.2.5.6c 
Kaplan-Meier Plot of Progression Free Survival (Cohort 3, Safety 
Population) 
Figure 14.2.5.6d 
Kaplan-Meier Plot of Progression Free Survival (Cohort 4, Safety 
Population) 
Figure 14.2.5.6e 
Kaplan-Meier Plot of Progression Free Survival (Cohort 5, Safety 
Population) 
 
Table 14.2.6a 
Serum AFP, CA19-9, CEA (Cohort 2, Response Evaluable 
Population) 
Table 14.2.6b 
Serum AFP, CA19-9, CEA (Cohort 4, Response Evaluable 
Population) 
 
Figure 14.2.7a 
Serum AFP, CA19-9, CEA (Cohort 2, Response Evaluable 
Population) 
Figure 14.2.7b 
Serum AFP, CA19-9, CEA (Cohort 4, Response Evaluable 
Population) 
 
Listing 16.2.6.1 
Target Lesions (RECIST) 
Listing 16.2.6.2 
Non-Target and New Lesions (RECIST) 
Listing 16.2.6.3 
Measurable Lesions (RANO) 
Listing 16.2.6.4 
Non-Measurable and New Lesions (RANO) 
Listing 16.2.6.5 
Response Assessment (RECIST) 
Listing 16.2.6.6 
Response Assessment (RANO and LGG RANO) 
Listing 16.2.6.7 
Response Assessment (Cheson) 
Listing 16.2.6.8 
Survival Status 
Listing 16.2.6.9 
Serum AFP, CA19-9, CEA 
 
4.3.2. 
Quality of Life Assessment Analysis 
The EQ-5D-5L is a validated assessment of the quality of life which consists of five 
dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.  
Each dimension has 5 levels of one’s health state: no problems, slight problems, 
moderate problems, severe problems and extreme problems.  The patient indicates his/her 
health state by selecting the most appropriate statement in each of the five dimensions. 
This decision results in a 1-digit number that expresses the level selected for that 
dimension.  The digits for the five dimensions can be combined into a 5-digit number that 
describes the patient’s health state.   
EQ-5D-5L data will be summarized by nominal visit for the Response Evaluable 
Population.  The number and percentage of patients reporting each score per dimension 
will be summarized, as well as the number reporting some problems on that dimension 
(score >1).  The change from baseline in the number reporting some problems in each 
dimension will also be reported (raw and percent change).  Furthermore, a stacked bar 


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chart will be produced to illustrate the EQ-5D-5L values.  In the chart, the x axis will 
represent nominal visit (screening, cycle 3, and end of treatment) and the y axis will 
represent percentage.  Each bar will add to 100% and be color coded to represent the 
percent of patients reporting each level (1-5) of problems within the dimension for that 
visit.  A table below the figure will show the number of patients contributing data to each 
visit.  A separate chart will be created for each of the dimensions.  This figure will be 
created for each cohort and treatment regimen. 
All EQ-5D-5L data will be listed. 
Table 14.2.8a 
EQ-5D-5L Summary (Cohort 1, Response Evaluable Population) 
Table 14.2.8b 
EQ-5D-5L Summary (Cohort 2, Response Evaluable Population) 
Table 14.2.8c 
EQ-5D-5L Summary (Cohort 3, Response Evaluable Population) 
Table 14.2.8d 
EQ-5D-5L Summary (Cohort 4, Response Evaluable Population) 
Table 14.2.8e 
EQ-5D-5L Summary (Cohort 5, Response Evaluable Population) 
Figure 14.2.9a 
EQ-5D-5L Quality of Life Assessment (Cohort 1, Response 
Evaluable Population) 
Figure 14.2.9b 
EQ-5D-5L Quality of Life Assessment (Cohort 2, Response 
Evaluable Population) 
Figure 14.2.9c 
EQ-5D-5L Quality of Life Assessment (Cohort 3, Response 
Evaluable Population) 
Figure 14.2.9d 
EQ-5D-5L Quality of Life Assessment (Cohort 4, Response 
Evaluable Population) 
Figure 14.2.9e 
EQ-5D-5L Quality of Life Assessment (Cohort 5, Response 
Evaluable Population) 
 
Listing 16.2.6.10 
EQ5D-5L Quality of Life Assessment 
4.4. 
Pharmacokinetic and Pharmacodynamic Evaluations 
Pharmacokinetic analyses will be conducted using the PK population.  Pharmacodynamic 
analyses will be conducted on the 2-HG biomarker using the Pharmacodynamic 
population.   
Evaluation of 2-HG has been done in a number of types of biological samples for this 
study: plasma, urine, and for glioma patients magnetic resonance spectroscopy (MRS) 
evaluation of 2-HG in tumor tissue, and cerebral spinal fluid.  Each of these types of 2-
HG evaluations will be summarized separately; they will not be combined.  2-HG will be 
summarized for each disease cohort and treatment regimen by actual value, change from 
baseline, and percent change by nominal visit.  In such tables, unscheduled visit results 
will not be included.  Furthermore, 2-HG will also be summarized by subgroup.  Percent 
change from baseline will be plotted in a box plot where the x-axis will represent nominal 
visit and the y-axis will represent percent change from baseline, and separate boxes will 
be plotted for sample type (plasma, tumor tissue, CSF, urine).  Separate figures will be 
produced for each cohort. 


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Pharmacokinetic variables will be calculated from the plasma concentration data using 
standard non-compartmental methods.  The pharmacokinetic variables to be determined 
are summarized below: 
Table 1 
Pharmacokinetic Parameters for Analysis 
Parameter 
Description 
AUCall 
Area under the concentration versus time curve from Time 0 (pre-dose) to the last quantifiable 
concentration ; calculated using the linear-log trapezoidal method. 
AUCtau 
Area under the concentration versus time curve over the dosing interval at steady-state; 
calculated using the linear-log trapezoidal method. 
Cmin 
The trough plasma concentration taken prior to a subsequent dose. 
Cmax 
Maximum plasma concentration; the highest concentration observed during a dosage interval. 
Tmax 
The time Cmax was observed. 
 
 
FT-2102 concentrations below the lower limit of quantitation (LLOQ) will be indicated 
by BLQ in the listings and will be treated as follows: 
• For pre-dose samples prior to the FT-2102 administration: Concentrations that are 
BLQ or missing will be assigned a numerical value of zero for the calculation of 
AUC. Any anomalous concentration values observed at pre-dose will be included 
in the computation of AUC. If the pre-dose concentration is greater than 5% of 
Cmax, the data will be evaluated on a case-by-case basis to determine if exclusion 
of the affected profile is warranted.   
For all other BLQ concentrations: Any other BLQ concentrations will be assigned a value 
of zero if they precede quantifiable samples in the initial portion of the concentration-
time profile. A BLQ value that occurs between quantifiable data points, especially prior 
to Cmax, will be evaluated to determine if an assigned concentration of zero makes sense, 
or if exclusion of the data is warranted. Following Cmax, BLQ values embedded between 
2 quantifiable data points will be treated as missing when calculating AUC. If BLQ 
values occur at the end of the collection interval (after the last quantifiable 
concentration), these will be set to zero. If consecutive BLQ concentrations are followed 
by quantifiable concentrations in the terminal portion of the concentration curve, these 
quantified values will be excluded from the PK analysis by setting them to missing, 
unless otherwise warranted by the concentration-time profile. 
Pharmacokinetic concentration data will be listed by patient including actual sampling 
times relative to dosing. Plasma concentrations will be summarized by disease cohort, 
treatment regimen, and nominal visit. The following descriptive statistics will be 
presented at each nominal time point: n, arithmetic mean, standard deviation, coefficient 
of variation (CV%), geometric mean, geometric standard deviation, geometric CV%, 
median, minimum and maximum values.   
For each cohort, the individual plasma concentration versus actual time profiles for each 
patient, as well as the geometric mean plasma concentration versus nominal time profiles 
will be presented graphically on a linear-linear and log-linear scale.  


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The following PK parameters will be listed by patient and summarized by disease cohort, 
and treatment regimen. Descriptive statistics for calculated PK parameters will include: n, 
arithmetic mean, standard deviation, CV%, geometric mean, median, minimum and 
maximum values. No descriptive statistics will be presented for an individual PK 
parameter when fewer than three patients have values for that parameter. 
All plasma and CSF (if any) concentration and pharmacodynamic data and the per-patient 
pharmacokinetic parameters will be displayed in data listings. 
Table 14.2.10.1a 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 1, PD Population) 
Table 14.2.10.1b 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 2, PD Population) 
Table 14.2.10.1c 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 3, PD Population) 
Table 14.2.10.1d 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 4, PD Population) 
Table 14.2.10.1e 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 5, PD Population) 
 
Table 14.2.10.2a 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 1, PD Population) 
Table 14.2.10.2b 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 2, PD Population) 
Table 14.2.10.2c 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 3, PD Population) 
Table 14.2.10.2d 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 4, PD Population) 
Table 14.2.10.2e 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 5, PD Population) 
 
Figure 14.2.11.1a 
Boxplot of Plasma 2-HG by Time Point (Cohort 1, PD Population) 
Figure 14.2.11.1b 
Boxplot of Plasma 2-HG by Time Point (Cohort 2, PD Population) 
Figure 14.2.11.1c 
Boxplot of Plasma 2-HG by Time Point (Cohort 3, PD Population) 
Figure 14.2.11.1d 
Boxplot of Plasma 2-HG by Time Point (Cohort 4, PD Population) 
Figure 14.2.11.1e 
Boxplot of Plasma 2-HG by Time Point (Cohort 5, PD Population) 
Figure 14.2.11.2a 
Boxplot of Urine 2-HG by Time Point (Cohort 1, PD Population) 
Figure 14.2.11.2b 
Boxplot of Urine 2-HG by Time Point (Cohort 2, PD Population) 
Figure 14.2.11.2c 
Boxplot of Urine 2-HG by Time Point (Cohort 3, PD Population) 
Figure 14.2.11.2d 
Boxplot of Urine 2-HG by Time Point (Cohort 4, PD Population) 
Figure 14.2.11.2e 
Boxplot of Urine 2-HG by Time Point (Cohort 5, PD Population) 


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Figure 14.2.11.3 
Boxplot of Tumor 2-HG Assessed by MRS by Time Point (Cohort 
1, PD Population) 
Figure 14.2.11.4 
Boxplot of CSF 2-HG by Time Point (Cohort 1, PD Population) 
 
Table 14.2.12a 
FT-2102 Plasma Concentration over Time (Cohort 1, PK 
Population) 
Table 14.2.12b 
FT-2102 Plasma Concentration over Time (Cohort 2, PK 
Population) 
Table 14.2.12c 
FT-2102 Plasma Concentration over Time (Cohort 3, PK 
Population) 
Table 14.2.12d 
FT-2102 Plasma Concentration over Time (Cohort 4, PK 
Population) 
Table 14.2.12e 
FT-2102 Plasma Concentration over Time (Cohort 5, PK 
Population) 
 
Table 14.2.13a 
Summary of Pharmacokinetic Parameters (All Patients on Single 
Agent Therapy, PK Population) 
Table 14.2.13b 
Summary of Pharmacokinetic Parameters (Cohort 1, PK 
Population) 
Table 14.2.13c 
Summary of Pharmacokinetic Parameters (Cohort 2, PK 
Population) 
 Table 14.2.13d 
Summary of Pharmacokinetic Parameters (Cohort 3, PK 
Population) 
 Table 14.2.13e 
Summary of Pharmacokinetic Parameters (Cohort 4, PK 
Population) 
Table 14.2.13f 
Summary of Pharmacokinetic Parameters (Cohort 5, PK 
Population) 
 
Figure 14.2.14.1a 
Geometric Mean FT-2102 Plasma Concentration over Time 
(Cohort 1, PK Population) 
Figure 14.2.14.1b 
Geometric Mean FT-2102 Plasma Concentration over Time 
(Cohort 2, PK Population) 
Figure 14.2.14.1c 
Geometric Mean FT-2102 Plasma Concentration over Time 
(Cohort 3, PK Population) 
Figure 14.2.14.1d 
Geometric Mean FT-2102 Plasma Concentration over Time 
(Cohort 4, PK Population) 
Figure 14.2.14.1e 
Geometric Mean FT-2102 Plasma Concentration over Time 
(Cohort 5, PK Population) 
 


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Figure 14.2.14.2a 
Geometric Mean FT-2102 Plasma Concentration over Log-Time 
(Cohort 1, PK Population) 
Figure 14.2.14.2b 
Geometric Mean FT-2102 Plasma Concentration over Log-Time 
(Cohort 2, PK Population) 
Figure 14.2.14.2c 
Geometric Mean FT-2102 Plasma Concentration over Log-Time 
(Cohort 3, PK Population) 
Figure 14.2.14.2d 
Geometric Mean FT-2102 Plasma Concentration over Log-Time 
(Cohort 4, PK Population) 
Figure 14.2.14.2e 
Geometric Mean FT-2102 Plasma Concentration over Log-Time 
(Cohort 5, PK Population) 
 
Figure 14.2.15a 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (All Patients on Single Agent Therapy, PK Population) 
Figure 14.2.15b 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 1, PK Population) 
Figure 14.2.15c 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 2, PK Population) 
Figure 14.2.15d 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 3, PK Population) 
Figure 14.2.15e 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 4, PK Population) 
Figure 14.2.15f 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 5, PK Population) 
 
Listing 16.2.5.4 
Pharmacokinetic Concentrations 
Listing 16.2.5.5 
Pharmacokinetic Parameters 
Listing 16.2.6.11 
2-HG MRS Assessments 
Listing 16.2.6.12 
Archival Tumor Tissue and Tumor Biopsy 
Listing 16.2.6.13 
Pharmacogenomics Samples  
 


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4.5. 
Safety Analyses 
Safety analyses will be conducted using the Safety population.  In tables summarizing 
data by cycle, only cycles with 3 or more patients having data for the cycle will be 
summarized. 
4.5.1. 
Study Drug Exposure 
Study drug exposure will be characterized by duration of exposure, amount of exposure, 
and percent compliance.  Additionally, in the summary table containing duration of 
exposure, the number of patients and events of the following types will be summarized: 
dose reduced, dose increased, dose held, drug withdrawn, and non-compliance.  These 
parameters will be calculated over all for the study and summarized by cohort.  Amount 
of exposure and percent compliance will also be calculated by cycle and tabulated.  
Additionally, these parameters will be listed, along with raw data from the exposure and 
drug accountability logs. 
Duration of FT-2102 Exposure: Duration of study drug exposure to FT-2102 will be 
calculated as the number of days that patients were administered study drug, as 
determined below, and will be summarized by treatment group using descriptive 
statistics.   
𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝑜𝑜𝑜𝑜 𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆 𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸= (𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝑜𝑜𝑜𝑜 𝑙𝑙𝑎𝑎𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠−𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷) + 1 
Total assigned dose (mg): For each cycle, the total assigned dose will be calculated for 
each log line in the FT-2102 administration form as: total assigned dose= (assigned 
dose*1 (if frequency= QD) or assigned dose*2 if frequency=BID)*number of days 
comprising the log line (eg. End date-start date+1).  To get the total assigned dose for the 
cycle, the sum of the log lines within the cycle will be calculated.  To get the total 
assigned dose for the study, the sum of the total assigned dose for all cycles will be 
calculated. 
Total dose not taken and not returned (mg): This will be calculated from the drug 
accountability log.  This will be calculated by taking the number of pills dispensed (last 
cycle)-number of pills returned (this cycle)-doses taken per patient diary (this cycle).  
That yields the number of pills taken and not returned, to get the dose taken and not 
returned, multiply the number of pills taken and not returned by the pill strength.  
Total dose taken (mg): for each cycle the total dose taken will be calculated based on the 
drug accountability log.  The number of tablets dispensed times the tablet strength (50 or 
150 mg) will yield the total dose dispensed and the number of tablets returned times the 
tablet strength will yield the total dose returned.  Total dose taken equals total dose 
dispensed minus total dose returned minus total dose not taken and not returned.  This 
will be calculated by cycle, and then the sum of all cycles will yield the total dose taken 
for the study. 
Percent compliance: percent compliance will be calculated by cycle and overall for the 
study.  It is calculated as the total assigned dose-total dose taken, divided by total assign 


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Percent compliance= (total assigned dose – (total assigned dose-total dose taken))     *100 
 
 
 
 
total assigned dose 
For patients receiving combination therapy, the combination drugs are administered via 
IV or SC.  Duration of treatment with combination agents and duration of total treatment 
including IV therapy and oral therapy (in days) will be presented by treatment group for 
the Safety and Response Evaluable populations, where duration of treatment is calculated 
as the end date minus the start date plus 1.  Descriptive statistics (both continuous and 
categorical) will also be presented for the number of doses received for IV therapy.  The 
number of patients who experienced dose interruptions will be tabulated, as well as the 
reason for the interruption (e.g., adverse event, other reason). 
Dosing information for each patient will be presented in a data listing. 
Relevant Output 
Table 14.2.16.1a 
Study Drug Exposure (Cohort 1, Response Evaluable Population) 
Table 14.2.16.1b 
Study Drug Exposure (Cohort 2, Response Evaluable Population) 
Table 14.2.16.1c 
Study Drug Exposure (Cohort 3, Response Evaluable Population) 
Table 14.2.16.1d 
Study Drug Exposure (Cohort 4, Response Evaluable Population) 
Table 14.2.16.1e 
Study Drug Exposure (Cohort 5, Response Evaluable Population) 
Table 14.2.16.2a 
Study Drug Exposure (Cohort 1, Safety Population) 
Table 14.2.16.2b 
Study Drug Exposure (Cohort 2, Safety Population) 
Table 14.2.16.2c 
Study Drug Exposure (Cohort 3, Safety Population) 
Table 14.2.16.2d 
Study Drug Exposure (Cohort 4, Safety Population) 
Table 14.2.16.2e 
Study Drug Exposure (Cohort 5, Safety Population) 
Table 14.2.17a 
Study Drug Exposure to Azacitidine (Cohort 1, Safety Population) 
Table 14.2.17b 
Study Drug Exposure to Nivolumab (Cohort 2, Safety Population) 
Table 14.2.17c 
Study Drug Exposure to Azacitidine (Cohort 3, Safety Population) 
Table 14.2.17d 
Study Drug Exposure to Gemcitabine and Cisplatin (Cohort 4, 
Safety Population) 
 
Listing 16.2.5.1 
FT-2102 Administration 
Listing 16.2.5.2 
Drug Accountability 
Listing 16.2.5.3 
Azacitidine, Nivolumab, Cisplatin, and Gemcitibine 
Administration 
 
4.5.2. 
Adverse Events 
All AEs will be coded using the MedDRA coding system and displayed in tables and data 
listings using system organ class (SOC) and preferred term. 


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Analyses of adverse events will be performed for those events that are considered 
treatment-emergent.  A treatment-emergent adverse event (TEAE) is an AE that begins or 
worsens in the period from the first dose of study treatment to 28 days after the last dose of 
study drug.  Study drug is defined as FT-2102 or, for patients assigned to receive 
combination therapy, azacitidine, nivolumab, gemcitabine, or cisplatin. 
Adverse events are summarized by patient incidence rates; therefore, in any tabulation, a 
patient contributes only once to the count for a given adverse event, SOC, or preferred 
term. 
The number and percentage of patients with any treatment-emergent adverse event, with 
any treatment-emergent adverse event assessed by the Investigator as related to treatment 
(definite, probable, or possible relationship), and with any serious adverse event will be 
summarized by treatment group and overall.  In these tabulations, each patient will 
contribute only once (i.e., the most related occurrence or the most intense occurrence) to 
each of the incidence rates in the descriptive analysis, regardless of the number of 
episodes.   
An additional summary of TEAEs will be produced in which MedDRA PTs are 
presented, sorted from most frequent to least.   
No formal hypothesis-testing analysis of adverse event incidence rates will be performed. 
All adverse events gathered in the clinical database, whether treatment emergent or not, 
will be listed in patient data listings. 
By-patient listings also will be provided for the following: patient deaths, serious adverse 
events, adverse events leading to withdrawal, and dose-limiting toxicities.   
Relevant Output 
Table 14.3.1.1a 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 1, Safety Population) 
Table 14.3.1.1b 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 2, Safety Population) 
Table 14.3.1.1c 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 3, Safety Population) 
Table 14.3.1.1d 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 4, Safety Population) 
Table 14.3.1.1e 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 5, Safety Population) 
 
Table 14.3.1.a 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients Receiving Single Agent 
Therapy, Safety Population) 


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Table 14.3.1.b 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients Receiving Combination 
Therapy, Safety Population) 
Table 14.3.1.c 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients, Safety Population) 
Table 14.3.1.d 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.e 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.2f 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.g 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 4, Safety Population) 
Table 14.3.1.h 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 5, Safety Population) 
 
 
Table 14.3.1.3a 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 1, 
Safety Population) 
Table 14.3.1.3b 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 2, 
Safety Population) 
Table 14.3.1.3c 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 3, 
Safety Population) 
Table 14.3.1.3d 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 4, 
Safety Population) 
Table 14.3.1.3e 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 5, 
Safety Population) 
 
Table 14.3.1.4a 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.4b 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.4c 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.4d 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 4, Safety Population) 


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Table 14.3.1.4e 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 5, Safety Population) 
Table 14.3.1.5a 
Severe Treatment-Emergent Adverse Events Related to FT-2102 
by MedDRA System Organ Class and Preferred Term (Cohort 1, 
Safety Population) 
Table 14.3.1.5b 
Severe Treatment-Emergent Adverse Events Related to FT-2102 
by MedDRA System Organ Class and Preferred Term (Cohort 2, 
Safety Population) 
Table 14.3.1.5c 
Severe Treatment-Emergent Adverse Events Related to FT-2102 
by MedDRA System Organ Class and Preferred Term (Cohort 3, 
Safety Population) 
Table 14.3.1.5d 
Severe Treatment-Emergent Adverse Events Related to FT-2102 
by MedDRA System Organ Class and Preferred Term (Cohort 4, 
Safety Population) 
Table 14.3.1.5e 
Severe Treatment-Emergent Adverse Events Related to FT-2102 
by MedDRA System Organ Class and Preferred Term (Cohort 5, 
Safety Population) 
 
Table 14.3.1.6a 
TEAEs by MedDRA Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.6b 
TEAEs by MedDRA Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.6c 
TEAEs by MedDRA Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.6d 
TEAEs by MedDRA Preferred Term (Cohort 4, Safety Population) 
Table 14.3.1.6e 
TEAEs by MedDRA Preferred Term (Cohort 5, Safety Population) 
 
Table 14.3.2.1 
Listing of Deaths 
Table 14.3.2.2 
Listing of Serious Adverse Events 
Table 14.3.2.3 
Listing of Adverse Events Resulting in Drug Interruptions or 
Withdrawals  
Table 14.3.2.4 
Listing of Dose-Limiting Toxicities 
Listing 16.2.7.1 
Adverse Events by Patient and Verbatim Term 
Listing 16.2.7.2 
Adverse Events by Patient and MedDRA System Organ Class and 
Preferred Term 
Listing 16.2.7.3 
Adverse Events by MedDRA System Organ Class, Preferred Term, 
Cohort, and Patient 
4.5.3. 
Laboratory Data 
Clinical laboratory values (including hematology, coagulation, chemistry, and urinalysis) 
will be expressed in SI units.  CTCAE v 4.03 grading will be applied to laboratory values 
(for laboratory tests that are graded by CTCAE).  In cases where a laboratory reports only 
hematology differentials in percentage, the absolute values may be derived 


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programmatically for reporting.  The derivation of the absolute value would be calculated 
by taking the percent of the absolute WBC value. 
The actual value and change from baseline to each on-study evaluation will be 
summarized for each clinical laboratory parameter, including hematology and clinical 
chemistry.  In the event of repeat values, the last non-missing value per study day/time 
will be used.  Unscheduled laboratory draws will not be included in these summaries.  
Coagulation labs are only drawn pre-treatment, and so will be combined with the 
hematology table for applicable visits. 
Shifts from baseline to worst CTCAE grade experienced on study will be presented.  In 
cases where CTCAE grades may be bi-directional (i.e., sodium, potassium), shifts to 
highest value and lowest value will be presented.  Unscheduled laboratory draws will be 
included in the consideration of worst value on study. 
A separate summary of liver function test abnormalities will be produced, based on the 
FDA’s guidance for industry on drug induced liver injury (June 2009), in addition to the 
summaries described above.  The number and percentage of patients experiencing the 
following abnormalities will be summarized for the Safety analysis set.  A supportive 
listing of this data will also be produced illustrating which values have received flags 
applied to this table. 
Clinical Laboratory Parameter 
Category 
ALT 
>3 × ULN; >5 × ULN; >10 × ULN; >20 × ULN 
AST 
>3 × ULN; >5 × ULN; >10 × ULN; >20 × ULN 
AST or ALT 
>3 × ULN; >5 × ULN; >10 × ULN; >20 × ULN 
Total Bilirubin (TBL) 
>1.5 × ULN; ≥2 × ULN 
ALP  
>2.5 × ULN; >5 x ULN 
Concurrent AST, ALT and Total Bilirubin  
(ALT or AST >3 x ULN) and (TBL >1.5 x ULN);  
(ALT or AST >3 x ULN) and (TBL >2 x ULN) 
Concurrent AST, ALT and Total Bilirubin 
without ALP abnormality 
(ALT or AST >3 x ULN) and (TBL >1.5 x ULN);  
(ALT or AST >3 x ULN) and (TBL >2 x ULN) 
ALT>3 x ULN or AST>3 x ULN with 
Concurrent report of selected TEAEs during 
study 
(ALT > 3 x ULN) or (AST >3 x ULN and with TEAEs*  
*Selected TEAEs include nausea, vomiting, anorexia, abdominal pain, abdominal discomfort, fatigue, 
jaundice, pruritus, chromaturia, and feces discolored.  
Concurrent test values are defined as post-baseline values measured within +/- 7 days of 
test dates for the related parameters. 
All laboratory data will be provided in data listings, and will be flagged with CTCAE 
grade if applicable, and H or L if above or below the normal limit. 


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Subset listings will be presented for all abnormal laboratory values and laboratory values 
with CTCAE severity grade 3 or 4. 
Relevant Output 
Table 14.3.4.1 
Listing of Abnormal Laboratory Values 
Table 14.3.4.2 
Listing of Laboratory Values with CTCAE Severity ≥Grade 3 
Table 14.3.4.3 
Listing of Liver Function Tests of Potential Concern 
Table 14.3.5.1a 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 1, Safety Population) 
Table 14.3.5.1b 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 2, Safety Population) 
Table 14.3.5.1c 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 3, Safety Population) 
Table 14.3.5.1d 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 4, Safety Population) 
Table 14.3.5.1e 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 5, Safety Population) 
Table 14.3.5.2a 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 1, Safety 
Population) 
Table 14.3.5.2b 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 2, Safety 
Population) 
Table 14.3.5.2c 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 3, Safety 
Population) 
Table 14.3.5.2d 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 4, Safety 
Population) 
Table 14.3.5.2e 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 5, Safety 
Population) 
Table 14.3.6.1a 
Shifts from Baseline to Worst Value on Study in Hematology and 
Coagulation, Overall and by Dose Group (Cohort 1, Safety 
Population) 


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Table 14.3.6.1b 
Shifts from Baseline to Worst Value on Study in Hematology and 
Coagulation, Overall and by Dose Group (Cohort 2, Safety 
Population) 
Table 14.3.6.1c 
Shifts from Baseline to Worst Value on Study in Hematology and 
Coagulation, Overall and by Dose Group (Cohort 3, Safety 
Population) 
Table 14.3.6.1d 
Shifts from Baseline to Worst Value on Study in Hematology and 
Coagulation, Overall and by Dose Group (Cohort 4, Safety 
Population) 
Table 14.3.6.1e 
Shifts from Baseline to Worst Value on Study in Hematology and 
Coagulation, Overall and by Dose Group (Cohort 5, Safety 
Population) 
Table 14.3.6.2a 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 1, Safety Population) 
Table 14.3.6.2b 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 2, Safety Population) 
Table 14.3.6.2c 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 3, Safety Population) 
Table 14.3.6.2d 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 4, Safety Population) 
Table 14.3.6.2e 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 5, Safety Population) 
Table 14.3.7a 
Summary of Liver Function Test Results (All Patients Receiving 
Single Agent Therapy, Safety Population) 
Table 14.3.7b 
Summary of Liver Function Test Results (Cohort 1, Safety 
Population) 
Table 14.3.7c 
Summary of Liver Function Test Results (Cohort 2, Safety 
Population) 
Table 14.3.7d 
Summary of Liver Function Test Results (Cohort 3, Safety 
Population) 
Table 14.3.7e 
Summary of Liver Function Test Results (Cohort 4, Safety 
Population) 
Table 14.3.7f 
Summary of Liver Function Test Results (Cohort 5, Safety 
Population) 
Listing 16.2.8.1 
Laboratory Results: Hematology 
Listing 16.2.8.2 
Laboratory Results: Chemistry 
Listing 16.2.8.3 
Laboratory Results: Urinalysis 
Listing 16.2.8.4 
Laboratory Results: Coagulation 
Listing 16.2.8.5 
Laboratory Normal Ranges 
Listing 16.2.8.6 
Laboratory Results: Other Screening Tests and Pregnancy Tests 


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4.5.4. 
Vital Signs and Physical Examination 
The actual value and change from baseline to each on-study evaluation will be 
summarized for vital signs. 
Vital sign measurements will be presented for each patient in a data listing. 
All physical examinations will be presented in a data listing. 
Relevant Output 
Table 14.3.8a 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 1, Safety Population) 
Table 14.3.8b 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 2, Safety Population) 
Table 14.3.8c 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 3, Safety Population) 
Table 14.3.8d 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 4, Safety Population) 
Table 14.3.8e 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 5, Safety Population) 
Listing 16.2.9.1 
Vital Signs 
Listing 16.2.9.2 
Physical Examinations 
4.5.5. 
Electrocardiogram 
Electrocardiogram results will be summarized descriptively, including the number and 
percentage of patients with normal, abnormal, and clinically significant abnormal results 
at baseline and each study visit. 
In addition, the number and percentage of patient experiencing the following events will 
be tabulated and summarized by baseline QTcF (<450, ≥450 to ≤480, ≥481 to ≤500, 
≥501): 
Absolute change from baseline in QTcF at any time during study 
• >30 to ≤60 msec 
• >60 msec 
Reaching a value in QTcF at any time during study 
• ≥450 to ≤480 msec 
• ≥481 to ≤500 msec 
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A scatter plot will also be produced which plots a single dot for each patient in the Safety 
set.  It will plot the patient’s baseline QTcF on the x axis and the maximum post baseline 
QTcF on the Y axis.  Reference lines will be shown at 450 on both axes.  
Electrocardiogram data for each patient will be provided in a data listing. 
Relevant Output 
Table 14.3.9a 
Electrocardiogram Results (Cohort 1, Safety Population) 
Table 14.3.9b 
Electrocardiogram Results (Cohort 2, Safety Population) 
Table 14.3.9c 
Electrocardiogram Results (Cohort 3, Safety Population) 
Table 14.3.9d 
Electrocardiogram Results (Cohort 4, Safety Population) 
Table 14.3.9e 
Electrocardiogram Results (Cohort 5, Safety Population) 
Table 14.3.10a 
QTcF Shifts from Baseline (Single Agent Therapy, Safety 
Population) 
Table 14.3.10b 
QTcF Shifts from Baseline (Combination Therapy, Safety 
Population) 
Figure 14.3.10.2a 
Maximum Post Baseline QTcF vs Baseline QTcF (Single Agent 
Therapy, Safety Population) 
Figure 14.3.10.2b 
Maximum Post Baseline QTcF vs Baseline QTcF (Combination 
Therapy, Safety Population) 
Listing 16.2.9.3 
Electrocardiogram Results 
4.5.6. 
Concomitant Medications and Procedures 
Concomitant medication is a medication taken during the treatment period.  It will be 
operationally defined as any medication with a start date prior to the date of the first dose 
of study treatment and continuing after the first dose of study treatment or with a start 
date between the dates of the first and last dose of study treatment.  Any medication with 
a start date after the date of the last dose of study treatment will not be considered a 
concomitant medication.  Any medication with a start and end date before the first dose 
of study treatment will be considered a prior medication.  Concomitant medications will 
be coded using the WHO Drug Dictionary.  Results will be tabulated by anatomic 
therapeutic class (ATC) and preferred term.   
If there are parts of the start date or stop date of the medication, to determine whether the 
medication is prior or concomitant, rules described in Section 3.10 will be used. 
The concomitant medications will be summarized by ATC classification and PT. For 
each medication term, the numbers and percentages of patients experiencing a medication 
with that term. If a patient reports the occurrence of a medication more than once, the 
medication is only counted once.  These will be summarized for the Safety Population. 
The use of prior and concomitant medications will be included in a by-patient data 
listing. 


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Concomitant procedures experienced while on study will not be summarized; they will be 
listed. 
Systemic steroid use is gathered only for glioma patients as it is part of what is 
considered for RANO response assessment.  This data will not be summarized; it will be 
listed. 
Relevant Output 
Table 14.3.11a 
Concomitant Medications (Cohort 1, Safety Population) 
Table 14.3.11b 
Concomitant Medications (Cohort 2, Safety Population) 
Table 14.3.11c 
Concomitant Medications (Cohort 3, Safety Population) 
Table 14.3.11d 
Concomitant Medications (Cohort 4, Safety Population) 
Table 14.3.11e 
Concomitant Medications (Cohort 5, Safety Population) 
Listing 16.2.9.4 
Prior and Concomitant Medications 
Listing 16.2.9.5 
Concomitant Procedures 
Listing 16.2.9.6 
Systemic Steroid Dosing 
 
4.5.7. 
Performance Status 
The ECOG Scale of Performance Status describes a patient’s level of functioning in 
terms of their ability to care for themselves, daily activity, and physical ability (walking, 
working, etc.).  All ECOG performance status data will be listed. 
Listing 16.2.9.7 
ECOG Performance Status 
 
 


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5. 
EXPLORATORY ANALYSES 
Quantification of ctDNA over time will be analyzed in an exploratory fashion.  
Phamacogenomics will also be analyzed in an exploratory manner.  The results of these 
analyses may be presented in a separate report. 
 


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6. 
CHANGES TO PLANNED ANALYSES 
All changes from procedures outlined in the protocol and procedures outlined in this SAP 
will be summarized in the study report.  Decisions to deviate from planned analyses will 
be documented at the time they are made. 
If any modifications in the experimental design, dosages, parameters, patient selection, or 
any other sections of the protocol are indicated or required, the Investigator will consult 
with the Sponsor before such changes are instituted.  Modifications will be accomplished 
through formal amendments to this protocol by the Sponsor and approval from the 
appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC). 


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7. 
REFERENCES 
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA.  (2014) 
Recommendations for initial evaluation, staging, and response assessment of Hodgkin and Non-
Hodgkin lymphoma: the Lugano classification. J Clin Onc. 32(27): 3059-3067. 
Eisenhauer EA, Therasse P, Bogaerts J, et al. (2009) New response evaluation criteria in solid 
tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 45(2):228-47. 
Food and Drug Administration. (2009). Guidance for Industry Drug Induced Liver Injury: 
Premarketing Clinical Evaluation. 
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X (2011). 
Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual 
Life Res. Dec; 20(10):1727-1736 
International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use.  (1995). ICH harmonized tripartite guideline structure and 
content of clinical study reports E3.  
Oken M, Creech R, Tormey D, et al. (1982). Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 5: 649-655. 
van den Bent MJ, Wefel JS, Schiff D, et al. (2011) Response assessment in neuro-oncology (a 
report of the RANO group): assessment of outcome in trials of diffuse low-grade gliomas. Lancet 
Oncol. 12(6): 583-93. 
Wen PY, Macdonald DR, Reardon DA, et al. (2010) Updated response assessment criteria for 
high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 28(11): 
1963-72.


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8. 
CLINICAL STUDY REPORT APPENDICES 


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8.1. 
Statistical Tables and Figures to be Generated 
Disposition/Demographics/Baseline (CSR Table Section 14.1) 
Table 14.1.1a 
Patient Enrollment and Disposition (Cohort 1) 
Table 14.1.1b 
Patient Enrollment and Disposition (Cohort 2) 
Table 14.1.1c 
Patient Enrollment and Disposition (Cohort 3) 
Table 14.1.1d 
Patient Enrollment and Disposition (Cohort 4) 
Table 14.1.1e 
Patient Enrollment and Disposition (Cohort 5) 
 
Table 14.1.2.1a 
Demographics and Baseline Characteristics (Cohort 1, Response 
Evaluable Population) 
Table 14.1.2.1b 
Demographics and Baseline Characteristics (Cohort 2, Response 
Evaluable Population) 
Table 14.1.2.1c 
Demographics and Baseline Characteristics (Cohort 3, Response 
Evaluable Population) 
Table 14.1.2.1d 
Demographics and Baseline Characteristics (Cohort 4, Response 
Evaluable Population) 
Table 14.1.2.1e 
Demographics and Baseline Characteristics (Cohort 5, Response 
Evaluable Population) 
 
Table 14.1.2.2a 
Demographics and Baseline Characteristics (Cohort 1, Safety 
Population) 
Table 14.1.2.2b 
Demographics and Baseline Characteristics (Cohort 2, Safety 
Population) 
Table 14.1.2.2c 
Demographics and Baseline Characteristics (Cohort 3, Safety 
Population) 
Table 14.1.2.2d 
Demographics and Baseline Characteristics (Cohort 4, Safety 
Population) 
Table 14.1.2.2e 
Demographics and Baseline Characteristics (Cohort 5, Safety 
Population) 
 
Table 14.1.3.1 
Baseline Disease Characteristics (Cohort 1, Response Evaluable 
Population) 
Table 14.1.3.1b 
Baseline Disease Characteristics (Cohort 2, Response Evaluable 
Population) 
Table 14.1.3.1c 
Baseline Disease Characteristics (Cohort 3, Response Evaluable 
Population) 
Table 14.1.3.1d 
Baseline Disease Characteristics (Cohort 4, Response Evaluable 
Population) 
Table 14.1.3.1e 
Baseline Disease Characteristics (Cohort 5, Response Evaluable 
Population) 


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Table 14.1.3.2a 
Baseline Disease Characteristics (Cohort 1, Safety Population) 
Table 14.1.3.2b 
Baseline Disease Characteristics (Cohort 2, Safety Population) 
Table 14.1.3.2c 
Baseline Disease Characteristics (Cohort 3, Safety Population) 
Table 14.1.3.2d 
Baseline Disease Characteristics (Cohort 4, Safety Population) 
Table 14.1.3.2e 
Baseline Disease Characteristics (Cohort 5, Safety Population) 
 
Table 14.1.4.1a 
IDH1 and Other Mutations (Cohort 1, Response Evaluable 
Population) 
Table 14.1.4.1b 
IDH1 and Other Mutations (Cohort 2, Response Evaluable 
Population) 
Table 14.1.4.1c 
IDH1 and Other Mutations (Cohort 3, Response Evaluable 
Population) 
Table 14.1.4.1d 
IDH1 and Other Mutations (Cohort 4, Response Evaluable 
Population) 
Table 14.1.4.1e 
IDH1 and Other Mutations (Cohort 5, Response Evaluable 
Population) 
 
Table 14.1.4.2a 
IDH1 and Other Mutations (Cohort 1, Safety Population) 
Table 14.1.4.2b 
IDH1 and Other Mutations (Cohort 2, Safety Population) 
Table 14.1.4.2c 
IDH1 and Other Mutations (Cohort 3, Safety Population) 
Table 14.1.4.2d 
IDH1 and Other Mutations (Cohort 4, Safety Population) 
Table 14.1.4.2e 
IDH1 and Other Mutations (Cohort 5, Safety Population) 
 
Table 14.1.5.1a 
Prior Therapies (Cohort 1, Response Evaluable Population) 
Table 14.1.5.1b 
Prior Therapies (Cohort 2, Response Evaluable Population) 
Table 14.1.5.1c 
Prior Therapies (Cohort 3, Response Evaluable Population) 
Table 14.1.5.1d 
Prior Therapies (Cohort 4, Response Evaluable Population) 
Table 14.1.5.1e 
Prior Therapies (Cohort 5, Response Evaluable Population) 
 
Table 14.1.5.2a 
Prior Therapies (Cohort 1, Safety Population) 
Table 14.1.5.2b 
Prior Therapies (Cohort 2, Safety Population) 
Table 14.1.5.2c 
Prior Therapies (Cohort 3, Safety Population) 
Table 14.1.5.2d 
Prior Therapies (Cohort 4, Safety Population) 
Table 14.1.5.2e 
Prior Therapies (Cohort 5, Safety Population) 
 
Table 14.1.6a 
Medical History (Cohort 1, Safety Population) 
Table 14.1.6b 
Medical History (Cohort 2, Safety Population) 
Table 14.1.6c 
Medical History (Cohort 3, Safety Population) 
Table 14.1.6d 
Medical History (Cohort 4, Safety Population) 
Table 14.1.6e 
Medical History (Cohort 5, Safety Population) 


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Efficacy/Pharmacokinetic Results (CSR Table Section 14.2) 
Table 14.2.1a 
Disease Response Assessment Overall and by Subgroup (Cohort 1, 
Response Evaluable Population) 
Table 14.2.1b 
Disease Response Assessment Overall and by Subgroup (Cohort 2, 
Response Evaluable Population) 
Table 14.2.1c 
Disease Response Assessment Overall and by Subgroup (Cohort 3, 
Response Evaluable Population) 
Table 14.2.1d 
Disease Response Assessment Overall and by Subgroup (Cohort 4, 
Response Evaluable Population) 
Table 14.2.1e 
Disease Response Assessment Overall and by Subgroup (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.2.1a 
Maximum Decrease from Baseline in Tumor Burden (Cohort 1 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2a 
Maximum Decrease from Baseline in Tumor Burden (Cohort 1 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1b 
Maximum Decrease from Baseline in Tumor Burden (Cohort 2 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2b 
Maximum Decrease from Baseline in Tumor Burden (Cohort 2 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1c 
Maximum Decrease from Baseline in Tumor Burden (Cohort 3 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2c 
Maximum Decrease from Baseline in Tumor Burden (Cohort 3 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1d 
Maximum Decrease from Baseline in Tumor Burden (Cohort 4 
Single Agent, Response Evaluable Population) 
Figure 14.2.2.2d 
Maximum Decrease from Baseline in Tumor Burden (Cohort 4 
Combination Therapy, Response Evaluable Population) 
Figure 14.2.2.1e 
Maximum Decrease from Baseline in Tumor Burden (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.3.1a 
Time on Treatment (Cohort 1 Single Agent, Safety Population) 
Figure 14.2.3.2a 
Time on Treatment (Cohort 1 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1b 
Time on Treatment (Cohort 2 Single Agent, Safety Population) 
Figure 14.2.3.2b 
Time on Treatment (Cohort 2 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1c 
Time on Treatment (Cohort 3 Single Agent, Safety Population) 
Figure 14.2.3.2c 
Time on Treatment (Cohort 3 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1d 
Time on Treatment (Cohort 4 Single Agent, Safety Population) 


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Figure 14.2.3.2d 
Time on Treatment (Cohort 4 Combination Therapy, Safety 
Population) 
Figure 14.2.3.1e 
Time on Treatment (Cohort 5, Safety Population) 
 
Table 14.2.4a 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 1, Response Evaluable 
Population) 
Table 14.2.4b 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 2, Response Evaluable 
Population) 
Table 14.2.4c 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 3, Response Evaluable 
Population) 
Table 14.2.4d 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 4, Response Evaluable 
Population) 
Table 14.2.4e 
Progression-Free Survival, Time to Progression, Duration of 
Response, and Time to Response (Cohort 5, Response Evaluable 
Population) 
 
Table 14.2.5.1 
Overall Survival (Response Evaluable Population) 
Table14.2.5.2 
Overall Survival (Safety Population) 
 
Figure 14.2.5.3a 
Kaplan-Meier Plot of Overall Survival (Cohort 1, Response 
Evaluable Population) 
Figure 14.2.5.3b 
Kaplan-Meier Plot of Overall Survival (Cohort 2, Response 
Evaluable Population) 
Figure 14.2.5.3c 
Kaplan-Meier Plot of Overall Survival (Cohort 3, Response 
Evaluable Population) 
Figure 14.2.5.3d 
Kaplan-Meier Plot of Overall Survival (Cohort 4, Response 
Evaluable Population) 
Figure 14.2.5.3e 
Kaplan-Meier Plot of Overall Survival (Cohort 5, Response 
Evaluable Population) 
 
Figure 14.2.5.4a 
Kaplan-Meier Plot of Overall Survival (Cohort 1, Safety 
Population) 
Figure 14.2.5.4b 
Kaplan-Meier Plot of Overall Survival (Cohort 2, Safety 
Population) 
Figure 14.2.5.4c 
Kaplan-Meier Plot of Overall Survival (Cohort 3, Safety 
Population) 


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Figure 14.2.5.4d 
Kaplan-Meier Plot of Overall Survival (Cohort 4, Safety 
Population) 
Figure 14.2.5.4e 
Kaplan-Meier Plot of Overall Survival (Cohort 5, Safety 
Population) 
 
Figure 14.2.5.5a 
Kaplan-Meier Plot of Progression Free Survival (Cohort 1, 
Response Evaluable Population) 
Figure 14.2.5.5b 
Kaplan-Meier Plot of Progression Free Survival (Cohort 2, 
Response Evaluable Population) 
Figure 14.2.5.5c 
Kaplan-Meier Plot of Progression Free Survival (Cohort 3, 
Response Evaluable Population) 
Figure 14.2.5.5d 
Kaplan-Meier Plot of Progression Free Survival (Cohort 4, 
Response Evaluable Population) 
Figure 14.2.5.5e 
Kaplan-Meier Plot of Progression Free Survival (Cohort 5, 
Response Evaluable Population) 
 
Figure 14.2.5.6a 
Kaplan-Meier Plot of Progression Free Survival (Cohort 1, Safety 
Population) 
Figure 14.2.5.6b 
Kaplan-Meier Plot of Progression Free Survival (Cohort 2, Safety 
Population) 
Figure 14.2.5.6c 
Kaplan-Meier Plot of Progression Free Survival (Cohort 3, Safety 
Population) 
Figure 14.2.5.6d 
Kaplan-Meier Plot of Progression Free Survival (Cohort 4, Safety 
Population) 
Figure 14.2.5.6e 
Kaplan-Meier Plot of Progression Free Survival (Cohort 5, Safety 
Population) 
 
 
Table 14.2.6a 
Serum AFP, CA19-9, CEA (Cohort 2, Response Evaluable 
Population) 
Table 14.2.6b 
Serum AFP, CA19-9, CEA (Cohort 4, Response Evaluable 
Population) 
 
Figure 14.2.7a 
Serum AFP, CA19-9, CEA (Cohort 2, Response Evaluable 
Population) 
Figure 14.2.7b 
Serum AFP, CA19-9, CEA (Cohort 4, Response Evaluable 
Population) 
 
Table 14.2.8a 
EQ-5D-5L Summary (Cohort 1, Response Evaluable Population) 
Table 14.2.8b 
EQ-5D-5L Summary (Cohort 2, Response Evaluable Population) 
Table 14.2.8c 
EQ-5D-5L Summary (Cohort 3, Response Evaluable Population) 


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Table 14.2.8d 
EQ-5D-5L Summary (Cohort 4, Response Evaluable Population) 
Table 14.2.8e 
EQ-5D-5L Summary (Cohort 5, Response Evaluable Population) 
 
Figure 14.2.9a 
EQ-5D-5L Quality of Life Assessment (Cohort 1, Response 
Evaluable Population) 
Figure 14.2.9b 
EQ-5D-5L Quality of Life Assessment (Cohort 2, Response 
Evaluable Population) 
Figure 14.2.9c 
EQ-5D-5L Quality of Life Assessment (Cohort 3, Response 
Evaluable Population) 
Figure 14.2.9d 
EQ-5D-5L Quality of Life Assessment (Cohort 4, Response 
Evaluable Population) 
Figure 14.2.9e 
EQ-5D-5L Quality of Life Assessment (Cohort 5, Response 
Evaluable Population) 
 
Table 14.2.10.1a 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 1, PD Population) 
Table 14.2.10.1b 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 2, PD Population) 
Table 14.2.10.1c 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 3, PD Population) 
Table 14.2.10.1d 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 4, PD Population) 
Table 14.2.10.1e 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline (Cohort 5, PD Population) 
 
Table 14.2.10.2a 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 1, PD Population) 
Table 14.2.10.2b 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 2, PD Population) 
Table 14.2.10.2c 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 3, PD Population) 
Table 14.2.10.2d 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 4, PD Population) 
Table 14.2.10.2e 
Summary of 2-HG, Change from Baseline, and Percent Change 
from Baseline by Subgroup (Cohort 5, PD Population) 
 
Figure 14.2.11.1a 
Boxplot of Plasma 2-HG by Time Point (Cohort 1, PD Population) 
Figure 14.2.11.1b 
Boxplot of Plasma 2-HG by Time Point (Cohort 2, PD Population) 
Figure 14.2.11.1c 
Boxplot of Plasma 2-HG by Time Point (Cohort 3, PD Population) 


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Figure 14.2.11.1d 
Boxplot of Plasma 2-HG by Time Point (Cohort 4, PD Population) 
Figure 14.2.11.1e 
Boxplot of Plasma 2-HG by Time Point (Cohort 5, PD Population) 
Figure 14.2.11.2a 
Boxplot of Urine 2-HG by Time Point (Cohort 1, PD Population) 
Figure 14.2.11.2b 
Boxplot of Urine 2-HG by Time Point (Cohort 2, PD Population) 
Figure 14.2.11.2c 
Boxplot of Urine 2-HG by Time Point (Cohort 3, PD Population) 
Figure 14.2.11.2d 
Boxplot of Urine 2-HG by Time Point (Cohort 4, PD Population) 
Figure 14.2.11.2e 
Boxplot of Urine 2-HG by Time Point (Cohort 5, PD Population) 
Figure 14.2.11.3 
Boxplot of Tumor 2-HG Assessed by MRS by Time Point (Cohort 
1, PD Population) 
Figure 14.2.11.4 
Boxplot of CSF 2-HG by Time Point (Cohort 1, PD Population) 
 
Table 14.2.13a 
Summary of Pharmacokinetic Parameters (All Patients on Single 
Agent Therapy, PK Population) 
Table 14.2.13b 
Summary of Pharmacokinetic Parameters (Cohort 1, PK 
Population) 
Table 14.2.13c 
Summary of Pharmacokinetic Parameters (Cohort 2, PK 
Population) 
 Table 14.2.13d 
Summary of Pharmacokinetic Parameters (Cohort 3, PK 
Population) 
 Table 14.2.13e 
Summary of Pharmacokinetic Parameters (Cohort 4, PK 
Population) 
Table 14.2.13f 
Summary of Pharmacokinetic Parameters (Cohort 5, PK 
Population) 
 
Figure 14.2.14.1a 
FT-2102 Plasma Concentration over Time (Cohort 1, PK 
Population) 
Figure 14.2.14.1b 
FT-2102 Plasma Concentration over Time (Cohort 2, PK 
Population) 
Figure 14.2.14.1c 
FT-2102 Plasma Concentration over Time (Cohort 3, PK 
Population) 
Figure 14.2.14.1d 
FT-2102 Plasma Concentration over Time (Cohort 4, PK 
Population) 
Figure 14.2.14.1e 
FT-2102 Plasma Concentration over Time (Cohort 5, PK 
Population) 
 
Figure 14.2.14.2a 
FT-2102 Plasma Concentration over Log-Time (Cohort 1, PK 
Population) 
Figure 14.2.14.2b 
FT-2102 Plasma Concentration over Log-Time (Cohort 2, PK 
Population) 


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Figure 14.2.14.2c 
FT-2102 Plasma Concentration over Log-Time (Cohort 3, PK 
Population) 
Figure 14.2.14.2d 
FT-2102 Plasma Concentration over Log-Time (Cohort 4, PK 
Population) 
Figure 14.2.14.2e 
FT-2102 Plasma Concentration over Log-Time (Cohort 5, PK 
Population) 
 
Figure 14.2.15a 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (All Patients on Single Agent Therapy, PK Population) 
Figure 14.2.15b 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 1, PK Population) 
Figure 14.2.15c 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 2, PK Population) 
Figure 14.2.15d 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 3, PK Population) 
Figure 14.2.15e 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 4, PK Population) 
Figure 14.2.15f 
FT-2102 Geometric Mean Plasma Concentration over Nominal 
Time (Cohort 5, PK Population) 
 
Table 14.2.16.1a 
FT-2102 Exposure (Cohort 1, Response Evaluable Population) 
Table 14.2.16.1b 
FT-2102 Exposure (Cohort 2, Response Evaluable Population) 
Table 14.2.16.1c 
FT-2102 Exposure (Cohort 3, Response Evaluable Population) 
Table 14.2.16.1d 
FT-2102 Exposure (Cohort 4, Response Evaluable Population) 
Table 14.2.16.1e 
FT-2102 Exposure (Cohort 5, Response Evaluable Population) 
Table 14.2.16.2a 
FT-2102 Exposure (Cohort 1, Safety Population) 
Table 14.2.16.2b 
FT-2102 Exposure (Cohort 2, Safety Population) 
Table 14.2.16.2c 
FT-2102 Exposure (Cohort 3, Safety Population) 
Table 14.2.16.2d 
FT-2102 Exposure (Cohort 4, Safety Population) 
Table 14.2.16.2e 
FT-2102 Exposure (Cohort 5, Safety Population) 
 
Table 14.2.17a 
Summary of Azacitidine Exposure (Cohort 1, Safety Population) 
Table 14.2.17b 
Summary of  Nivolumab Exposure (Cohort 2, Safety Population) 
Table 14.2.17c 
Summary of  Gemcitabine and Cisplatin Exposure (Cohort 3, 
Safety Population) 
Table 14.2.17d 
Summary of Azacitidine Exposure (Cohort 4, Safety Population) 


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Displays of Adverse Events (CSR Section 14.3.1) 
Table 14.3.1.1a 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 1, Safety Population) 
Table 14.3.1.1b 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 2, Safety Population) 
Table 14.3.1.1c 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 3, Safety Population) 
Table 14.3.1.1d 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 4, Safety Population) 
Table 14.3.1.1e 
Summary of Treatment-Emergent Adverse Events, Overall and by 
Dose Group (Cohort 5, Safety Population) 
 
Table 14.3.1.a 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients Receiving Single Agent 
Therapy, Safety Population) 
Table 14.3.1.b 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients Receiving Combination 
Therapy, Safety Population) 
Table 14.3.1.c 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (All Patients, Safety Population) 
Table 14.3.1.d 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.e 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.2f 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.g 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 4, Safety Population) 
Table 14.3.1.h 
Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Cohort 5, Safety Population) 
 
Table 14.3.1.3a 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 1, 
Safety Population) 
Table 14.3.1.3b 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 2, 
Safety Population) 
Table 14.3.1.3c 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 3, 
Safety Population) 


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Table 14.3.1.3d 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 4, 
Safety Population) 
Table 14.3.1.3e 
Treatment-Emergent Adverse Events Related to FT-2102 by 
MedDRA System Organ Class and Preferred Term (Cohort 5, 
Safety Population) 
 
Table 14.3.1.4a 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.4b 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.4c 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.4d 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 4, Safety Population) 
Table 14.3.1.4e 
Severe Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Cohort 5, Safety Population) 
 
Table 14.3.1.5a 
TEAEs by MedDRA Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.5b 
TEAEs by MedDRA Preferred Term (Cohort 2, Safety Population) 
Table 14.3.1.5c 
TEAEs by MedDRA Preferred Term (Cohort 3, Safety Population) 
Table 14.3.1.5d 
TEAEs by MedDRA Preferred Term (Cohort 4, Safety Population) 
Table 14.3.1.5e 
TEAEs by MedDRA Preferred Term (Cohort 5, Safety Population) 
Listings of Deaths, Serious Adverse Events, and Other Significant Events (CSR Section 
14.3.2) 
Table 14.3.2.1 
Listing of Deaths 
Table 14.3.2.2 
Listing of Serious Adverse Events 
Table 14.3.2.3 
Listing of Discontinuations Due to Adverse Events 
Table 14.3.2.4 
Listing of Dose-Limiting Toxicities 
Abnormal Laboratory Value Listings (CSR Section 14.3.4) 
Table 14.3.4.1 
Listing of Abnormal Laboratory Values 
Table 14.3.4.2 
Listing of Laboratory Values with CTCAE Severity ≥Grade 3 
Table 14.3.4.3 
Listing of Liver Function Tests of Potential Concern 
Other Safety Tabulations (CSR Section 14.3.5) 
Table 14.3.5.1a 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 1, Safety Population) 


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Table 14.3.5.1b 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 2, Safety Population) 
Table 14.3.5.1c 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 3, Safety Population) 
Table 14.3.5.1d 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 4, Safety Population) 
Table 14.3.5.1e 
Summary and Change from Baseline for Hematology and 
Coagulation Parameters by Time Point, Overall and by Dose 
Group (Cohort 5, Safety Population) 
Table 14.3.5.2a 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 1, Safety 
Population) 
Table 14.3.5.2b 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 2, Safety 
Population) 
Table 14.3.5.2c 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 3, Safety 
Population) 
Table 14.3.5.2d 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 4, Safety 
Population) 
Table 14.3.5.2e 
Summary and Change from Baseline for Chemistry Parameters by 
Time Point, Overall and by Dose Group (Cohort 5, Safety 
Population) 
 
Table 14.3.6.1a 
Shifts from Baseline to Worst Value on Study in Hematology, 
Overall and by Dose Group (Cohort 1, Safety Population) 
Table 14.3.6.1b 
Shifts from Baseline to Worst Value on Study in Hematology, 
Overall and by Dose Group (Cohort 2, Safety Population) 
Table 14.3.6.1c 
Shifts from Baseline to Worst Value on Study in Hematology, 
Overall and by Dose Group (Cohort 3, Safety Population) 
Table 14.3.6.1d 
Shifts from Baseline to Worst Value on Study in Hematology, 
Overall and by Dose Group (Cohort 4, Safety Population) 
Table 14.3.6.1e 
Shifts from Baseline to Worst Value on Study in Hematology, 
Overall and by Dose Group (Cohort 5, Safety Population) 
Table 14.3.6.2a 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 1, Safety Population) 


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Table 14.3.6.2b 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 2, Safety Population) 
Table 14.3.6.2c 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 3, Safety Population) 
Table 14.3.6.2d 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 4, Safety Population) 
Table 14.3.6.2e 
Shifts from Baseline to Worst Value on Study in Chemistry, 
Overall and by Dose Group (Cohort 5, Safety Population) 
 
Table 14.3.7a 
Summary of Liver Function Test Results (All Patients Receiving 
Single Agent Therapy, Safety Population) 
Table 14.3.7b 
Summary of Liver Function Test Results (Cohort 1, Safety 
Population) 
Table 14.3.7c 
Summary of Liver Function Test Results (Cohort 2, Safety 
Population) 
Table 14.3.7d 
Summary of Liver Function Test Results (Cohort 3, Safety 
Population) 
Table 14.3.7e 
Summary of Liver Function Test Results (Cohort 4, Safety 
Population) 
Table 14.3.7f 
Summary of Liver Function Test Results (Cohort 5, Safety 
Population) 
 
Table 14.3.8a 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 1, Safety Population) 
Table 14.3.8b 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 2, Safety Population) 
Table 14.3.8c 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 3, Safety Population) 
Table 14.3.8d 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 4, Safety Population) 
Table 14.3.8e 
Summary and Change from Baseline for Vital Signs by Time 
Point, Overall and by Dose Group (Cohort 5, Safety Population) 
 
Table 14.3.9a 
Electrocardiogram Results (Cohort 1, Safety Population) 
Table 14.3.9b 
Electrocardiogram Results (Cohort 2, Safety Population) 
Table 14.3.9c 
Electrocardiogram Results (Cohort 3, Safety Population) 
Table 14.3.9d 
Electrocardiogram Results (Cohort 4, Safety Population) 
Table 14.3.9e 
Electrocardiogram Results (Cohort 5, Safety Population) 
 
Table 14.3.10 
QTcF Shifts from Baseline (Cohort 1, Safety Population) 


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Table 14.3.11a 
Concomitant Medications (Cohort 1, Safety Population) 
Table 14.3.11b 
Concomitant Medications (Cohort 2, Safety Population) 
Table 14.3.11c 
Concomitant Medications (Cohort 3, Safety Population) 
Table 14.3.11d 
Concomitant Medications (Cohort 4, Safety Population) 
Table 14.3.11e 
Concomitant Medications (Cohort 5, Safety Population) 
8.2. 
Data Listings to be Generated 
Discontinued Patients (CSR Appendix 16.2.1) 
Listing 16.2.1.1 
Study Completion Status 
Listing 16.2.1.2 
Pre-Screening Consent 
Listing 16.2.1.3 
Enrollment Protocol Deviations (CSR Appendix 16.2.2) 
Listing 16.2.2.1 
Inclusion and Exclusion Criteria 
Listing 16.2.2.2 
Protocol Violations 
Patients Excluded from the Efficacy Analysis (CSR Appendix 16.2.3) 
Listing 16.2.3.1 
Analysis Sets 
Demographic and Baseline Characteristics (CSR Appendix 16.2.4) 
Listing 16.2.4.1 
Demographics and Baseline Characteristics 
Listing 16.2.4.2 
Baseline Disease Data and Cancer Diagnosis 
Listing 16.2.4.3 
IDH1 Mutation and Other Mutations 
Listing 16.2.4.4 
Medical History 
Listing 16.2.4.5 
Prior Anti-Cancer Therapies 
Listing 16.2.4.6 
Prior Radiotherapy 
Listing 16.2.4.7 
Major Surgical Tumor Resections 
Listing 16.2.4.8 
Child-Pugh Score 
Listing 16.2.4.9 
Hepatitis B and C 
Listing 16.2.4.10 
Archival Tumor Tissue 
Compliance and/or Drug Concentration Data (CSR Appendix 16.2.5) 
Listing 16.2.5.1 
FT-2102 Administration 
Listing 16.2.5.2 
Drug Accountability 
Listing 16.2.5.3 
Azacitidine, Nivolumab, Cisplatin, and Gemcitibine 
Administration 
Listing 16.2.5.4 
Pharmacokinetic Concentrations 
Listing 16.2.5.5 
Pharmacokinetic Parameters 
Individual Efficacy Response Data (CSR Appendix 16.2.6) 
Listing 16.2.6.1 
Target Lesions (RECIST) 
Listing 16.2.6.2 
Non-Target and New Lesions (RECIST) 
Listing 16.2.6.3 
Measurable Lesions (RANO) 


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Listing 16.2.6.4 
Non-Measurable and New Lesions (RANO) 
Listing 16.2.6.5 
Response Assessment (RECIST) 
Listing 16.2.6.6 
Response Assessment (RANO and LGG RANO) 
Listing 16.2.6.7 
Response Assessment (Cheson) 
Listing 16.2.6.8 
Survival Status 
Listing 16.2.6.9 
Serum AFP, CA19-9, CEA 
Listing 16.2.6.10 
EQ5D-5L Quality of Life  
Listing 16.2.6.11 
2-HG MRS Assessments 
Listing 16.2.6.12 
Archival Tumor Tissue and Tumor Biopsy 
Listing 16.2.6.13 
Pharmacogenomics Samples 
AssessmentAdverse Event Listings (CSR Appendix 16.2.7) 
Listing 16.2.7.1 
Adverse Events by Patient and Verbatim Term 
Listing 16.2.7.2 
Adverse Events by Patient and MedDRA System Organ Class and 
Preferred Term 
Listing 16.2.7.3 
Adverse Events by MedDRA System Organ Class, Preferred Term, 
Cohort, and Patient 
Listings of Individual Laboratory Measurements by Patient (CSR Appendix 16.2.8) 
Listing 16.2.8.1 
Laboratory Results: Hematology 
Listing 16.2.8.2 
Laboratory Results: Chemistry 
Listing 16.2.8.3 
Laboratory Results: Urinalysis 
Listing 16.2.8.4 
Laboratory Results: Coagulation 
Listing 16.2.8.5 
Laboratory Normal Ranges 
Listing 16.2.8.6 
Laboratory Results: Other Screening Tests and Pregnancy 
Other Safety Listings (CSR Appendix 16.2.9) 
Listing 16.2.9.1 
Vital Signs 
Listing 16.2.9.2 
Physical Examinations 
Listing 16.2.9.3 
Electrocardiogram Results 
Listing 16.2.9.4 
Prior and Concomitant Medications 
Listing 16.2.9.5 
Concomitant Procedures 
Listing 16.2.9.6 
Systemic Steroid Dosing 
Listing 16.2.9.7 
ECOG Performance Status 
 


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9. 
TABLE AND FIGURE SHELLS 


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Table 14.1.1a 
 
Patient Enrollment and Disposition (Cohort 1) 
 
Disposition 
Statistic 
Cohort 1A:  
FT-2102 
N (%) 
Cohort 1B: 
FT-2102 + AZA 
N (%) 
Cohort 1: 
 Overall 
N (%) 
Total Number of Patients 
 
Screened 
 
 
Screen Failures1 
 
  Enrolled1 
 
    Dosed2 
 
       Currently ongoing 3 
 
       Discontinued treatment3 
          Discontinued study participation3 
 
n 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
xx 
xx (xx) 
xx (xx) 
xx (xx) 
xx (xx) 
 
 
xx 
xx (xx) 
xx (xx) 
xx (xx) 
xx (xx) 
 
 
xx 
xx (xx) 
xx (xx) 
xx (xx) 
xx (xx) 
 
Study Populations2 
 
Safety 
 
DLT Evaluable 
 
Response Evaluable 
 
PK Analysis Set 
   PD Analysis Set 
 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
Primary Reason for Discontinuation of Treatment3 
 
Adverse Event 
 
Death 
 
Withdrew Consent 
 
Lost to Follow-up 
 
Patient Noncompliance 
 
Discontinuation of Study by Sponsor 
 
Protocol Violation 
 
Physician Decision 
 
Protocol Defined Disease Progression 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 


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Primary Reason for Discontinuation of Study 
Participation3 
 
Death 
 
Permanent Withdrawal of Consent 
 
Lost to Follow-up 
 
Patient Noncompliance/ Protocol Violation(s) 
 
Discontinuation of Study by Sponsor 
 
Physician Decision 
 
Pregnancy 
 
Protocol Defined Disease Progression 
 
Other 
 
 
 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
 
 
 
 
1 Percentage based on the number screened. 
2 Percentage based on the number enrolled. 
3 Percentage based on the number dosed. 
Source: Data Listing 16.2.x 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Programming Note: 
Repeat table for Cohorts 2-5. 
 


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Table 14.1.2.1a 
 
Demographics and Baseline Characteristics (Cohort 1, Response Evaluable Population) 
 
Demographics 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Age at consent (years) 
n 
mean 
SD 
median 
min - max 
Age category (years) 
18-40 
n (%) 
41-59 
n (%) 
>60 
n (%) 
Sex at birth 
Male 
n (%) 
Female 
n (%) 
Of childbearing potential 
n (%) 
Post-menopausal 
n (%) 
Sterilized 
n (%) 
Race 
American Indian or Alaska Native 
n (%) 
Asian 
n (%) 
Black or African American 
n (%) 
Native Hawaiian or Other Pacific Islander 
n (%) 
White 
n (%) 
Other 
n (%) 
Not Reported 
 
Ethnicity 
   Hispanic 
   Not Hispanic 
   Not reported 
n (%) 


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Height (cm) 
n 
mean 
SD 
median 
min - max 
Weight (kg) 
n 
mean 
SD 
median 
min - max 
BMI (kg/m^2) 
n 
mean 
SD 
median 
min - max 
ECOG Score 
0 n (%) 
1 n (%) 
2 n (%) 
3 n (%) 
4 n (%) 
Hepatitis B Status 
Negative 
n (%) 
Positive 
n (%) 
Hepatitis C Status 
Negative  
n (%) 
Positive 
n (%) 
IDH1 Mutation Subtype 
R132C 
n (%) 
R132H 
n (%) 
R132S 
n (%) 
R132L 
n (%) 
R132G 
n (%) 
Other 
n (%) 
Unknown 
n (%) 


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Programming Note: Repeat for Cohorts 2-5 
Programming Note: Use this shell for 14.1.2.2 (Safety Population) 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.1.3.1a 
 
Baseline Disease Characteristics (Cohort 1, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Current glioma diagnosis 
Diffuse astrocytoma, IDH mutant 
n (%) 
Diffuse astrocytoma, NOS 
n (%) 
Anaplastic astrocytoma, IDH mutant 
n (%) 
Anaplastic astrocytoma, NOS 
n (%) 
Glioblastoma, IDH mutant 
n (%) 
Glioblastoma, NOS 
n (%) 
Oligodendroglioma, IDH mutant 
n (%) 
Oligodendroglioma, NOS 
n (%) 
Anaplastic oligodendroglioma, IDH-mutant 
n (%) 
Anaplastic oligodendroglioma, NOS 
n (%) 
Oligoastrocytoma, NOS 
n (%) 
Anaplastic oligoastrocytoma, NOS 
n (%) 
Pilocytic astrocytoma 
n (%) 
Pilomyxoid astrocytoma 
n (%) 
Subependymal giant cell astrocytoma 
n (%) 
Pleomorphic xanthoastrocytoma 
n (%) 
Anaplastic pleomorphic xanthoastrocytoma 
n (%) 
Other 
n (%) 
Initial glioma diagnosis 
Diffuse astrocytoma, IDH mutant 
n (%) 
Diffuse astrocytoma, NOS 
n (%) 
Anaplastic astrocytoma, IDH mutant 
n (%) 
Anaplastic astrocytoma, NOS 
n (%) 
Glioblastoma, IDH mutant 
n (%) 
Glioblastoma, NOS 
n (%) 
Oligodendroglioma, IDH mutant 
n (%) 
Oligodendroglioma, NOS 
n (%) 
Anaplastic oligodendroglioma, IDH-mutant 
n (%) 
Anaplastic oligodendroglioma, NOS 
n (%) 


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Oligoastrocytoma, NOS 
n (%) 
Anaplastic oligoastrocytoma, NOS 
n (%) 
Pilocytic astrocytoma 
n (%) 
Pilomyxoid astrocytoma 
n (%) 
Subependymal giant cell astrocytoma 
n (%) 
Pleomorphic xanthoastrocytoma 
n (%) 
Anaplastic pleomorphic xanthoastrocytoma 
n (%) 
Other 
n (%) 
Years since initial diagnosis 
n 
mean 
SD 
median 
min - max 
Grade at initial diagnosis 
I 
n (%) 
II 
n (%) 
III 
n (%) 
IV 
n (%) 
Months since recurrence 
n 
mean 
SD 
median 
min - max 
Current grade 
I 
n (%) 
II 
n (%) 
III 
n (%) 
IV 
n (%) 
Unknown/ NA 
n (%) 
Baseline steroids 
Yes 
n (%) 
No 
n (%) 
Prior therapies 
Surgery only 
n (%) 
Medication and surgery 
n (%) 


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Number of prior regimens 
n 
mean 
SD 
median 
min - max 
Prior regimen categories 
1 
n (%) 
2 
n (%) 
3 
n (%) 
>3 
n (%) 
Prior IDH1 therapy 
Yes 
n (%) 
No 
n (%) 
Prior radiation 
Yes 
n (%) 
No 
n (%) 
Prior tezolomide 
Yes 
n (%) 
No 
n (%) 
  
  
  
Programming note: repeat for 14.1.3.2a (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.1.3.1b 
 
Baseline Disease Characteristics (Cohort 2, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 2A: 
Cohort 2B: 
Cohort 2: 
FT-2102 
FT-2102 + 
Nivolumab 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Hepatobiliary Cancer (HBC) Diagnosis 
Hepatocellular carcinoma 
n (%) 
Fibrolamellar 
n (%) 
Clear Cell  
n (%) 
Other 
n (%) 
Gallbladder carcinoma 
n (%) 
Intrahepatic cholangiocarcinoma 
n (%) 
Extraheptic cholangiocarcinoma 
n (%) 
Biliary tumor NOS 
n (%) 
Current Stage 
I 
n (%) 
IA 
n (%) 
IB 
n (%) 
IIA 
n (%) 
IIB 
n (%) 
IIIA 
n (%) 
IIIB 
n (%) 
IVA 
n (%) 
IVB 
n (%) 
NA 
n (%) 
Grade at Initial Diagnosis 
Gx 
n (%) 
G1 
n (%) 
G2 
n (%) 
G3 
n (%) 
G4 
n (%) 
Unknown 
n (%) 
Not Applicable 
n (%) 


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Years since initial diagnosis 
n 
mean 
SD 
median 
min - max 
Months since recurrence 
n 
mean 
SD 
median 
min - max 
Fibrosis 
F0 
n (%) 
F1 
n (%) 
Current TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 
T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Current TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Current TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 
Initial TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 


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T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Initial TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Initial TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 
Number of prior regimens 
n 
mean 
SD 
median 
min - max 
Prior regimen categories 
1 
n (%) 
2 
n (%) 
3 
n (%) 
>3 
n (%) 
Prior IDH1 therapy 
Yes 
n (%) 
No 
n (%) 
Child-Pugh Score 
n 
mean 
SD 
median 
min - max 
Child-Pugh Category 
A 
n (%) 
B 
n (%) 


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C 
n (%) 
  
  
  
Programming note: repeat for 14.1.3.2b (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Table 14.1.3.1c 
 
Baseline Disease Characteristics (Cohort 3, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 3A: 
Cohort 3B: 
Cohort 3: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Chondrosarcoma diagnosis 
Differentiated 
n (%) 
Mesenchymal 
n (%) 
Clear cell 
n (%) 
Unknown 
n (%) 
Other 
n (%) 
Current Stage 
Tx 
n (%) 
T0 
n (%) 
T1 
n (%) 
T1a 
n (%) 
T1b 
n (%) 
T2 
n (%) 
T2b 
n (%) 
T3 
n (%) 
T3a 
n (%) 
T3b 
n (%) 
T4 
n (%) 
Stage at initial diagnosis 
Tx 
n (%) 
T0 
n (%) 
T1 
n (%) 
T1a 
n (%) 
T1b 
n (%) 
T2 
n (%) 
T2b 
n (%) 
T3 
n (%) 
T3a 
n (%) 
T3b 
n (%) 


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81 
T4 
n (%) 
Current grade 
Gx 
n (%) 
G1 
n (%) 
G2 
n (%) 
G3 
n (%) 
G4 
n (%) 
Unknown 
n (%) 
Not Applicable 
n (%) 
Grade at Initial Diagnosis 
Gx 
n (%) 
G1 
n (%) 
G2 
n (%) 
G3 
n (%) 
Unknown 
n (%) 
Not Applicable 
n (%) 
Years since initial diagnosis 
n 
mean 
SD 
median 
min - max 
Months since recurrence 
n 
mean 
SD 
median 
min - max 
Current TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
T1 
n (%) 
T1a 
n (%) 
T1b 
n (%) 
T2 
n (%) 
T2a 
n (%) 
T2b 
n (%) 
T3 
n (%) 
T3a 
n (%) 


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T3b 
n (%) 
T4 
n (%) 
T4a 
n (%) 
T4b 
n (%) 
NA 
n (%) 
Current TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Current TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
M1a 
n (%) 
M1b 
n (%) 
Initial TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
T1 
n (%) 
T1a 
n (%) 
T1b 
n (%) 
T2 
n (%) 
T2a 
n (%) 
T2b 
n (%) 
T3 
n (%) 
T3a 
n (%) 
T3b 
n (%) 
T4 
n (%) 
T4a 
n (%) 
T4b 
n (%) 
NA 
n (%) 
Initial TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Initial TNM Staging: Metastasis (M) 


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M0 
n (%) 
M1 
n (%) 
M1a 
n (%) 
M1b 
n (%) 
Number of prior regimens 
n 
mean 
SD 
median 
min - max 
Prior regimen categories 
1 
n (%) 
2 
n (%) 
3 
n (%) 
>3 
n (%) 
Prior IDH1 therapy 
Yes 
n (%) 
No 
n (%) 
  
  
  
Programming note: repeat for 14.1.3.2c (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Table 14.1.3.1d 
 
Baseline Disease Characteristics (Cohort 4, Response Evaluable Population) 
Parameter 
Statistic 
Cohort 4A: 
Cohort 4B: 
Cohort 4: 
FT-2102 
FT-2102 + 
GemCis 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Current Stage 
I 
n (%) 
IA 
n (%) 
IB 
n (%) 
IIA 
n (%) 
IIB 
n (%) 
IIIA 
n (%) 
IIIB 
n (%) 
IVA 
n (%) 
IVB 
n (%) 
NA 
n (%) 
Initial Stage 
I 
n (%) 
IA 
n (%) 
IB 
n (%) 
IIA 
n (%) 
IIB 
n (%) 
IIIA 
n (%) 
IIIB 
n (%) 
IVA 
n (%) 
IVB 
n (%) 
NA 
n (%) 
Current Grade 
Gx 
n (%) 
G1 
n (%) 
G2 
n (%) 
G3 
n (%) 
Unknown 
n (%) 
Not Applicable 
n (%) 


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Grade at Initial Diagnosis 
Gx 
n (%) 
G1 
n (%) 
G2 
n (%) 
G3 
n (%) 
Unknown 
n (%) 
Not Applicable 
n (%) 
Years since initial diagnosis 
n 
mean 
SD 
median 
min - max 
Months since recurrence 
n 
mean 
SD 
median 
min - max 
Current TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 
T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Current TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Current TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 


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Initial TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 
T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Initial TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
NA 
n (%) 
Initial TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 
Number of prior regimens 
n 
mean 
SD 
median 
min - max 
Prior regimen categories 
1 
n (%) 
2 
n (%) 
3 
n (%) 
>3 
n (%) 
Prior IDH1 therapy 
Yes 
n (%) 
No 
n (%) 
Child-Pugh Score 
n 
mean 
SD 
median 
min - max 


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Child-Pugh Category 
A 
n (%) 
B 
n (%) 
C 
n (%) 
  
  
  
Programming note: repeat for 14.1.3.2d (Safety Population) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.1.3.1e 
 
Baseline Disease Characteristics (Cohort 5, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 5: 
 Overall 
N (%) 
Current Stage 
I 
n (%) 
IA 
n (%) 
IB 
n (%) 
IIA 
n (%) 
IIB 
n (%) 
IIIA 
n (%) 
IIIB 
n (%) 
IVA 
n (%) 
IVB 
n (%) 
NA 
n (%) 
Initial Stage 
I 
n (%) 
IA 
n (%) 
IB 
n (%) 
IIA 
n (%) 
IIB 
n (%) 
IIIA 
n (%) 
IIIB 
n (%) 
IVA 
n (%) 
IVB 
n (%) 
NA 
n (%) 
Years since initial diagnosis 
n 
mean 
SD 
median 
min - max 
Months since recurrence 
n 


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mean 
SD 
median 
min - max 
Current TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 
T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Current TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 
N1 
n (%) 
N2 
n (%) 
N3 
n (%) 
NA 
n (%) 
Current TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 
Initial TNM Staging: Primary Tumor (T) 
Tx 
n (%) 
T0 
n (%) 
Tis 
n (%) 
T1 
n (%) 
T2 
n (%) 
T3 
n (%) 
T4 
n (%) 
NA 
n (%) 
Initial TNM Staging: Lymph Node (N) 
Nx 
n (%) 
N0 
n (%) 


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N1 
n (%) 
N2 
n (%) 
N3 
n (%) 
NA 
n (%) 
Initial TNM Staging: Metastasis (M) 
M0 
n (%) 
M1 
n (%) 
NA 
n (%) 
Number of prior regimens 
n 
mean 
SD 
median 
min - max 
Prior regimen categories 
1 
n (%) 
2 
n (%) 
3 
n (%) 
>3 
n (%) 
Prior IDH1 therapy 
Yes 
n (%) 
No 
n (%) 
Child-Pugh Score 
n 
mean 
SD 
median 
min - max 
Child-Pugh Category 
A 
n (%) 
B 
n (%) 
C 
n (%) 
  
Programming note: repeat for 14.1.3.2e (Safety Population) 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 


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Protocol 2102-ONC-102 
Table 14.1.4.1a 
 
IDH1 and Other Mutations (Cohort 1, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
IDH1 Mutation Subtype 
R132C 
n (%) 
R132H 
n (%) 
R132S 
n (%) 
R132L 
n (%) 
R132G 
n (%) 
Other 
n (%) 
Unknown 
n (%) 
Other mutations 
ABL1 
n (%) 
ABL2 
n (%) 
ARID1A 
n (%) 
ARID2 
n (%) 
AXIN1 
n (%) 
(etc.) 
n (%) 
  
  
  
  
  
Programming notes: 
For other mutations show all mutations where at least 1 patient had the mutation.  List them in alphabetical order.  If a 
patient notes a mutation in the other, specify field then also show that mutation in this list. 
Repeat for Cohorts 2-5 
Repeat for 14.1.4.2a-14.1.4.2e (Safety population) 
 
 
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Protocol 2102-ONC-102 
Table 14.1.5a 
 
Prior Therapies (Cohort 1, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Drug class 1 
n (%) 
ATC text 1 
n (%) 
ATC text 2 
n (%) 
ATC text 3 
n (%) 
etc. 
n (%) 
Drug class 2 
n (%) 
ATC text 1 
n (%) 
ATC text 2 
n (%) 
ATC text 3 
n (%) 
etc. 
n (%) 
  
  
  
  
  
. 
  
Repeat for Cohorts 2-5 (Response Evaluable Population) 
Repeat for 14.1.5.2a-e (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Note: Prior anti-cancer therapy medications are coded with the WHO Drug version March 2018. 
 
 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.1.6a 
 
Medical History (Cohort 1, Safety Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
SOC 
n (%) 
PT1 
n (%) 
PT2 
n (%) 
PT3 
n (%) 
etc. 
n (%) 
SOC2 
n (%) 
PT1 
n (%) 
PT2 
n (%) 
PT3 
n (%) 
etc. 
n (%) 
  
  
  
  
  
Repeat for Cohorts 2-5 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Medical Histories are coded with the MedDRA version 21.0. 
 
 
 


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Protocol 2102-ONC-102 
Table 14.2.1a 
 
Disease Response Assessment Overall and by Subgroups (Cohort 1, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Best overall response 
n (%) 
Complete response (CR) 
n (%) 
Partial response (PR) 
n (%) 
Minor response (MR) 
n (%) 
Stable disease (SD) 
n (%) 
Progression (PD) 
n (%) 
Not evaluable 
n (%) 
Overall response rate (ORR) 
n (%) 
ORR by subgroups: 
Gender 
Male 
Responder 
n (%) 
Non-Responder 
n (%) 
Female 
Responder 
n (%) 
Non-Responder 
n (%) 
Race (Caucasian yes/ no) 
Caucasian 
Responder 
n (%) 
Non-Responder 
n (%) 
Non-Caucasian 
Responder 
n (%) 
Non-Responder 
n (%) 
Baseline ECOG 
0/1 
Responder 
n (%) 


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Non-Responder 
n (%) 
2 
Responder 
n (%) 
Non-Responder 
n (%) 
Age Category 
18-40 
Responder 
n (%) 
Non-Responder 
n (%) 
41-59 
Responder 
n (%) 
Non-Responder 
n (%) 
>=60 
Responder 
n (%) 
Non-Responder 
n (%) 
Prior therapy 
Surgery only 
Responder 
n (%) 
Non-Responder 
n (%) 
Surgery and medication 
Responder 
n (%) 
Non-Responder 
n (%) 
Number of prior regimens 
1 
Responder 
n (%) 
Non-Responder 
n (%) 
2 
Responder 
n (%) 
Non-Responder 
n (%) 
3 
Responder 
n (%) 
Non-Responder 
n (%) 
>3 
Responder 
n (%) 
Non-Responder 
n (%) 
Prior IDH1 therapy 
Yes 
Responder 
n (%) 
Non-Responder 
n (%) 


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No  
Responder 
n (%) 
Non-Responder 
n (%) 
Prior temozolomide 
Yes 
Responder 
n (%) 
Non-Responder 
n (%) 
No  
Responder 
n (%) 
Non-Responder 
n (%) 
Prior radiation therapy 
Yes 
Responder 
n (%) 
Non-Responder 
n (%) 
No  
Responder 
n (%) 
Non-Responder 
n (%) 
Baseline steroids 
Yes 
Responder 
n (%) 
Non-Responder 
n (%) 
No  
Responder 
n (%) 
Non-Responder 
n (%) 
Baseline tumor grade 
I 
Responder 
n (%) 
Non-Responder 
n (%) 
II 
Responder 
n (%) 
Non-Responder 
n (%) 
III 
Responder 
n (%) 
Non-Responder 
n (%) 
IV 
Responder 
n (%) 
Non-Responder 
n (%) 


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IDH mutation subtype 
R132H 
Responder 
n (%) 
Non-Responder 
n (%) 
R132C 
Responder 
n (%) 
Non-Responder 
n (%) 
other R132 subtypes 
Responder 
n (%) 
Non-Responder 
n (%) 
  
  
  
  
  
Repeat for Cohorts 2-5 
Programming note: for cohorts 2 and 4, refer to SAP for cohort-specific subgroups to add to the table, not shown in this 
shell. 
For cohorts 2 and higher, remove MR as a response option. 
 
 
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Protocol 2102-ONC-102 
Figure 14.2.2.1a 
 
Best Percent Change from Baseline in Tumor Burden (Cohort 1 Single Agent, Response Evaluable Population) 
 
 
 
 
 
Note: Baseline is the last imaging assessment performed before the patient’s first dose of FT-2102. 
Note: Best percent change is defined as maximum percentage reduction or minimum percentage increase at a single time point of 
the patient’s tumor burden post first dose of study drug. 
 
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Programming note: color code the bars by best overall response 
Programming note: Y-axis should be labeled “Maximum Decrease from Baseline (%)” 
Programming note: for Cohort 1, reference line should be at -50% for Cohort 1, and -30% for other cohorts. 
 
Programming note: Repeat for 14.2.2.2a-e (Combination Therapy) 
 
 


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Protocol 2102-ONC-102 
Figure 14.2.3.1a 
 
Time on Treatment (Cohort 1 Single Agent, Safety Population) 
 
 
 
 
Programming note: Repeat for 14.2.3.2a-e (Time on Treatment Combination Therapy) 
Programming note: color code by appropriate best overall response criteria, depending on Cohort being summarized.  This figure 
is for example only, the response categories used above are not to be used, follow appropriate disease-based response 
criteria. 
 
 
 


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Protocol 2102-ONC-102 
Table 14.2.4a 
 
Progression Free Survival, Time to Progression, Duration of Response, and Time to Response (Cohort 1, Response Evaluable Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Progression free survival (PFS; weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
PFS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Time to progression (TTP; weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
TTP 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Duration of response (DOR; weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
DOR 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Time to response (TTR; weeks) 
TTR 
n 
median 
95% CI for median 


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25-75%ile 
min - max 
  
  
  
  
  
Repeat for Cohorts 2-5 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
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Note: Progression Free Survival (PFS) is defined as the time from the date of the first dose to the date of disease progression 
or death, whichever is sooner. Time to Progression (TTP) is defined as the time from the date of the first dose to the date of 
disease progression. Duration of Response (DOR) is defined as the time from the date of the first CR, PR, or MR response to the 
date of disease progression. Time to Response (TTR) is defined as the time from the date of first dose to the date of first CR, 
PR or MR response. 
 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.2.5.1 
 
Overall Survival (Response Evaluable Population) 
 
Parameter 
Statistic 
FT-2102 
FT-2102 
combination 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Cohort 1 
Overall survival (weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
OS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Event free Rate (95% CI) 
3 months 
%(%,%) 
6 months 
%(%,%) 
9 months 
%(%,%) 
12 months 
%(%,%) 
Cohort 2 
Overall survival (weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
OS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Event free Rate (95% CI) 
3 months 
%(%,%) 
6 months 
%(%,%) 
9 months 
%(%,%) 
12 months 
%(%,%) 
Cohort 3 
Overall survival (weeks) 


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Patients with event 
n (%) 
Censored Patients 
n (%) 
OS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Event free Rate (95% CI) 
3 months 
%(%,%) 
6 months 
%(%,%) 
9 months 
%(%,%) 
12 months 
%(%,%) 
Cohort 4 
Overall survival (weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
OS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Event free Rate (95% CI) 
3 months 
%(%,%) 
6 months 
%(%,%) 
9 months 
%(%,%) 
12 months 
%(%,%) 
Cohort 5 
Overall survival (weeks) 
Patients with event 
n (%) 
Censored Patients 
n (%) 
OS 
n 
median 
95% CI for median 
25-75%ile 
min - max 
Event free Rate (95% CI) 
3 months 
%(%,%) 
6 months 
%(%,%) 
9 months 
%(%,%) 
12 months 
%(%,%) 
  
  
  


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Programming note: repeat for 14.2.5.2 (Safety Population) 
 
 
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DATE: HH:MM/DDMMMYYYY 
Note: Overall Survival (OS) is defined as the time from the date of the first dose to the date of death.   
 
 


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Protocol 2102-ONC-102 
Table 14.2.5.3a 
 
Kaplan-Meier Plot of Overall Survival (Cohort 1, Response Evaluable Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Overall Survival (OS) is defined as the time from the date of the first dose to the date of death. 
 
Programming note: Present different lines for single agent and combination arms, rather than treatments.   
Repeat for cohorts 2-5. 
Repeat for 14.2.5.4a-e Overall Survival(Safety Population), 14.2.5.5a-e Progression Free Survival (Response Evaluable 
Population), 14.2.5.6a-e Progression Free Survival (Safety Population) 
 


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Protocol 2102-ONC-102 
Table 14.2.6a 
 
Serum AFP, CA19-9, and CEA (Cohort 2, Safety Population) 
 
Parameter 
Statisti
c 
Cohort 2A: 
Cohort 2B: 
Cohort 2: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
Value 
Change 
from BL 
Pct. Chg fr 
BL 
Serum AFP 
Pre-Dose C1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
C3 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
(continue for 
all cycles 
present in data) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
CA19-9 
Pre-Dose C1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 


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28 June 2019, Version 2.0  
 
 
107 
C3 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
(continue for 
all cycles 
present in data) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
CEA 
Pre-Dose C1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
C3 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
(continue for 
all cycles 
present in data) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
  
min - 
max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
Programming note: repeat for Cohort 
4  
 


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28 June 2019, Version 2.0  
 
 
108 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Note: BL = baseline. 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
 
 
 


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2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
109 
 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Figure 14.2.7a 
 
Serum AFP, CA19-9, and CEA (Cohort 2, Response Evaluable Population) 
 
 
 
 
Programming note; Different colors indicate single agent and combination therapy.  Please include legend indicating this. 
Programming note; please include value and unit on Y-axis 
Programming note: via proc SGPANEL, matrix to include Serum AFP, CA19-9, and CEA on a single page. 
 
Repeat for Cohort 4 
 
 


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28 June 2019, Version 2.0  
 
 
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Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.8a 
 
EQ-5D-5L Summary (Cohort 1, Response Evaluable Set) 
 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
Dimension 
Level 
Statistic 
FT-2102 
FT-2102 
combination 
 Overall 
  Visit 
(N =  ) 
(N =  ) 
(N =  ) 
 
 
Mobility 
 
C1 
1 (no problems) 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
2 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
3 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
4 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
5 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
    Total 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  
 
 
 
 
Number reporting some 
problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 Change from BL in number 
reporting some problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  
 
 
 
 
 
C3 
1 (no problems) 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
2 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
3 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
4 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
5 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
    Total 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  
 
 
 
 
Number reporting some 
problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 Change from BL in number 
reporting some problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  
 
 
 
Treatment Termination 
1 (no problems) 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
2 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
111 
 
3 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
4 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
5 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
    Total 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  
 
 
 
 
Number reporting some 
problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 Change from BL in number 
reporting some problems 
n (%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Continue for other EQ-5D dimensions 
  
  
  
  
  
  
BL = baseline 
Repeat for Cohorts 2-5 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
Source: Data Listing 16.2.x 
 
 
 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
112 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Figure 14.2.9a 
 
EQ-5D-5L Quality of Life Assessment (Cohort 1, Response Evaluable Population) 
 
 
Programming notes: 
TRT will be displayed at the top left of the page, or of each graph that is presented on the page, whichever is most expedient. 
Y-axis label is “Percent”. 
Bars will be shaded as shown in the legend. 
All panels (Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety/Depression) will be presented in a 2x3 matrix on a 
single page.  (Programmer can use SGPANEL) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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28 June 2019, Version 2.0  
 
 
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Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.10.1a 
 
Summary of 2-HG, Change from Baseline, and Percent Change from Baseline (Cohort 1, PD Population) 
 
Parameter 
Time 
Point 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
Value 
Change 
from BL 
Pct. 
Chg fr 
BL 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
2-HG Plasma 
C1D1 
Pre-
dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
4 hours 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
C1D2 
Pre-
dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
(continu
e for all 
cycle/ days 
and time 
points) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
114 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
C3 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
(continu
e for all 
cycles 
present in 
data) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
2-HG CSF 
(present all days/ 
times) 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
2-HG Urine 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
(present all days/ 
times) 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
115 
  
  
min - max 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx xx - xx 
BL = Baseline 
Programming note: repeat for 
Cohorts 2-5  
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
116 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.10.2a 
 
Summary of 2-HG, Change from Baseline, and Percent Change from Baseline by Subgroup (Cohort 1, PD Population) 
 
Parameter 
Time 
Point 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Value 
Change 
from 
BL 
Pct. Chg 
fr BL 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
Value 
Change 
from BL 
Pct. Chg 
fr BL 
2-HG Plasma 
C1D1 
Male 
Pre-
dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
Female 
Pre-
dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
Male 
4 hours 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
Female 
4 hours 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
117 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
C1D1 
Predose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Male 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
Female 
n 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
min - max 
xx - 
xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - xx 
etc. 
  
  
  
  
  
  
  
  
  
  
  
BL = Baseline 
Programming note: continue for all 
subgroups 
Programming note: repeat for Cohorts 
2-5  
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
 
 
 
 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
118 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Figure 14.2.11.1a 
 
Plasma 2-HG by Time Point (Cohort 1, PD Population) 
 
 
 
 
Programming note; Different colors indicate single agent and combination therapy.  Please include legend indicating this. 
Programming note; please include value and unit on Y-axis 
 
Repeat for Cohorts 2-5. 
Repeat for Figure 14.2.11.2 Urine 2-HG, Figure 14.2.11.3 MRS 2-HG, and Figure 14.2.11.4 CSF 2-HG 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
119 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.12a 
 
Summary of Phamacokinetic Concentration over Time (Cohort 1, Pharmacokinetic Population) 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
 
FT-2102 
FT-2102 + AZA 
 Overall 
Visit, Time Point 
(N =  ) 
(N =  ) 
(N =  ) 
 
 
 
 
 
 
 
 
Cycle 1, 1 Hour 
n 
 
 
 
 
mean 
 
 
 
SD 
 
 
 
CV (%) 
 
 
 
Geometric mean 
 
 
 
Geometric SD 
 
 
 
 
median 
 
 
 
 
min - max 
 
 
 
Cycle 1, 2 Hours 
n 
 
 
 
mean 
 
 
 
SD 
 
 
 
 
Geometric mean 
 
 
 
 
Geometric SD 
 
 
 
median 
 
 
 
min - max 
 
 
 
 
 
 
Cycle 1, 4 Hours 
n 
 
 
 
mean 
 
 
 
SD 
 
 
 
 
Geometric mean 
 
 
 
 
Geometric SD 
 
 
 
median 
 
 
 
min - max 
 
 
 
 
 
 
 
 
Etc. for all time points and overall 
n 
mean 
SD 
 
Geometric mean 
 
 
 
 
Geometric SD 
 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
120 
median 
min - max 
Repeat for Cohorts 2-5 
) 
Programming note: summarize all cycles where n is 3 or more. 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
121 
 
FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.13a 
 
Summary of Phamacokinetic Parameters (All Patients on Single Agent Therapy, Pharmacokinetic Population) 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
Parameter 
FT-2102 
FT-2102 + AZA 
 Overall 
 
(N =  ) 
(N =  ) 
(N =  ) 
 
 
 
 
 
AUC0-24  
 
 
 
 
n 
 
 
 
 
mean 
 
 
 
SD 
 
 
 
CV (%) 
 
 
 
Geometric mean 
 
 
 
Geometric SD 
 
 
 
 
median 
 
 
 
 
min - max 
 
 
 
median 
min - max 
Etc. for all parameters 
n 
mean 
SD 
geometric mean 
geometric SD 
median 
min - max 
Repeat for Cohorts 1-5 
) 
Programming note: summarize all cycles where n is 3 or more. 
 
 
 
 
 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
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FORMA Therapeutics 
Confidential 
Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.14.1a 
Geometric Mean FT-2102 Plasma Concentration over Time (Cohort 1, PK Population) 
 
 
 
 
Note: Only one line is needed.  Plot geometric mean and use geometric SD for error bars. 
 
Repeat for:  
Figure 14.2.14.1 
Cohorts 2-5 
Figure 14.2.14.2 
FT-2102 Plasma Concentration over Log-Time (Cohort 1, PK Population), but modify x axis so that it is on the 
log scale. 
Figure 14.2.15a-f 
FT-2102 Geometric Mean Plasma Concentration over Nominal Time (PK Population) 


FORMA Therapeutics 
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28 June 2019, Version 2.0  
 
 
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FORMA Therapeutics  
 
 
 
 
Confidential 
 
 
 
 
 
       Page 1 of x 
Protocol 2102-ONC-102 
Table 14.2.16.1a 
 
Summary of FT-2102 Exposure (Cohort 1) 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
Visit 
FT-2102 
FT-2102 + AZA 
 Overall 
Parameter 
(N =  ) 
(N =  ) 
(N =  ) 
 
 
 
 
 
Overall 
 
 
 
Duration of FT-2102 exposure (days) 
n 
 
 
 
mean 
 
 
 
SD 
 
 
 
median 
 
 
 
min - max 
 
 
 
 
 
 
Total dose FT-2102 taken (mg) 
n 
 
 
 
mean 
 
 
 
SD 
 
 
 
median 
 
 
 
min - max 
 
 
 
 
 
 
Percent compliance 
n 
 
 
 
mean 
 
 
 
SD 
 
 
 
median 
 
 
 
min - max 
 
 
 
 
 
 
 
 
C1 
Duration of FT-2102 exposure (days) 
n 
mean 
SD 
median 
min - max 
Total dose FT-2102 taken (mg) 
n 
mean 
SD 
median 
min - max 


FORMA Therapeutics 
2102-ONC-102 Statistical Analysis Plan 
28 June 2019, Version 2.0  
 
 
124 
Percent compliance 
n 
mean 
SD 
median 
min - max 
(etc.  Summarize all cycles where there are 3 or more Patients overall). 
  
Repeat for Cohorts 2-5 
Repeat for 14.2.16.2 (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 


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Table 14.2.17a 
 
Summary of Azacitidine Exposure (Cohort 1, Safety Population) 
 
 
 
Statistic 
Cohort 1B: 
Visit 
FT-2102 + AZA 
Parameter 
(N =  ) 
 
 
 
Overall 
 
Duration of azacitidine exposure (days) 
n 
 
mean 
 
SD 
 
median 
 
min - max 
 
 
Number of doses of azacitidine 
n 
 
mean 
 
SD 
 
median 
 
min - max 
 
 
Number of patients with azacitidine dose interruptions 
n 
 
mean 
 
SD 
 
median 
 
min - max 
 
 
 
 


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Reason for interruption 
Adverse Event 
n (%) 
Other 
n (%) 
Number of Patients with Dose Modifications 
Dose Reduced 
n (%) 
Dose Increased 
n (%) 
Dose Held 
n (%) 
Dose Withdrawn 
n (%) 
  
  
  
Repeat for Cohorts 2-4, per appropriate combo drug 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.1.1a 
 
Summary of Adverse Events (Cohort 1, Safety Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + 
AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Patients with any AE 
n (%) 
Patients with any TEAE 
n (%) 
Patients with any Grade 3 or greater TEAE 
n (%) 
Patients with any Grade 4 or greater TEAE 
n (%) 
Patients with any Grade 5 TEAE 
n (%) 
Patients with DLT 
n (%) 
 
 
 
Patients with SAE 
n (%) 
Patients with treatment emergent SAE 
n (%) 
Patients with FT-2102 related TEAE 
n (%) 
Patients with azacitidine related TEAE 
n (%) 
Patients with FT-2102 related treatment emergent SAE 
n (%) 
Patients with TEAE related to FT-2102 resulting in dose 
interruption 
n (%) 
Patients with TEAE related to FT-2102 resulting in dose 
withdrawal 
n (%) 
Patients with TEAE related to FT-2102 resulting in dose reduction 
n (%) 
Patients with TEAE related to azacitidine resulting in dose 
interruption 
n (%) 
Patients with TEAE related to azacitidine resulting in dose 
withdrawal 
n (%) 
Patients with TEAE related to azacitidine resulting in dose 
reduction 
n (%) 
  
  
  
Repeat for Cohorts 2-5 
Programming note: when programming tables for cohorts 2-5, substitute the appropriate combination agent for the cohort. 
Cohorts 1 & 3 have azacitidine, cohort 2 has nivolumab, cohort 4 has gem/cis, cohort 5 has no combination therapy. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 


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Table 14.3.1.2a 
 
Treatment Emergent Adverse Events by MedDRA SOC and PT (Cohort 1, Safety Population) 
 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
System Organ Class (SOC) 
FT-2102 
FT-2102 + AZA 
 Overall 
Preferred Term (PT) 
(N =  ) 
(N =  ) 
(N =  ) 
SOC 1 
n (%) 
PT 1 
n (%) 
PT 2 
n (%) 
PT 3 
n (%) 
PT 4 
n (%) 
etc. for all terms 
n (%) 
SOC 2 
n (%) 
PT 1 
n (%) 
PT 2 
n (%) 
PT 3 
n (%) 
PT 4 
n (%) 
etc. for all terms 
n (%) 
etc. for all SOC/ PT 
  
  
  
  
  
Repeat for Cohorts 2-5 
Programming note: repeat for: 
Table 14.3.1.3: Treatment-Emergent Adverse Events Related to FT-2102 by MedDRA System Organ Class and Preferred Term (Safety Population) 
Table 14.3.1.4: Severe Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term (Cohort 1, Safety Population) 
Table 14.3.1.5: Severe Treatment-Emergent Adverse Events Related to FT-2102 by MedDRA System Organ Class and Preferred Term (Cohort 1, 
Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Patients are counted once in each SOC and PT.  Adverse Events are coded with the MedDRA version 21.0. 
 


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Table 14.3.1.6a 
Treatment Emergent Adverse Events by MedDRA Preferred Term (Cohort 1, Safety Population) 
 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
 
FT-2102 
FT-2102 + AZA 
 Overall 
Preferred Term (PT) 
(N =  ) 
(N =  ) 
(N =  ) 
PT 1 
n (%) 
PT 2 
n (%) 
PT 3 
n (%) 
PT 4 
n (%) 
etc. for all terms 
n (%) 
  
  
  
  
  
Repeat for Cohorts 2-5 
Programming note: sort preferred terms from most frequent to least frequent, based on the overall column. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Patients are counted once in each SOC and PT.  Adverse Events are coded with the MedDRA version 21.0. 
 
 


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Table 14.3.2.1 
 
Listing of Deaths (Safety Population) 
 
 
Cohort 
Patient 
Date of Last Dose 
Date of Death 
Rel Day 
Primary Cause of Death 
AE # 
 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Table 14.3.2.2 
 
Listing of Serious Adverse Events (Safety Population) 
 
Cohort 
Patient 
Verbatim 
Term 
Start 
Date/ 
Rel Day 
Stop 
Date/ 
Rel Day 
CTCAE 
Grade/ 
SAE 
Outcome 
Relationship to 
Drug 
Action Taken with 
Study Drug 
Other Action 
Taken 
FT-2102: unrelated 
FT-2102: None 
Aza: related 
Aza: Drug 
interrupted 
Programming note: in relationship and action columns, precede the information with the drug name being given in combination with FT-
2102. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 
4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 


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Table 14.3.2.3 
 
Listing of Adverse Events Resulting in Drug Interruptions or Withdrawals (Safety Population) 
 
Cohort 
Patient 
Verbati
m Term 
Start 
Date/ 
Rel Day 
Stop 
Date/ 
Rel Day 
CTCAE 
Grade 
SAE 
Outcome 
Relationship to 
Drug 
Action Taken 
with Study Drug 
Other Action 
Taken 
FT-2102: 
definite 
FT-2102: Drug 
Withdrawn 
Programming note: in relationship and action columns, precede the information with the drug name being given in combination 
with FT-2102. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 
4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.2.4 
 
Listing of Dose Limiting Toxicities (Safety Population) 
 
Cohort 
Patient 
Verbatim 
Term 
Start 
Date/ 
Rel Day 
Stop 
Date/ 
Rel Day 
CTCAE 
Grade 
SAE 
Outcome 
Relationship to 
Drug 
Action Taken 
with Study Drug 
Other Action 
Taken 
  
FT-2102: 
definite 
FT-2102: Drug 
Withdrawn 
Programming note: in relationship and action columns, precede the information with the drug name being given in combination with FT-
2102. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 
4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 
 


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Table 14.3.4.1 
 
Listing of Abnormal Laboratory Values (Safety Population) 
 
 
Cohort 
Patient 
Laboratory 
Category 
Test 
Name 
Sample 
date 
Rel 
Day 
Visit 
Name 
Result 
Units 
LLN 
ULN 
CTCAE 
Grade/ 
Flag 
Clinical 
Significance 
Chemistry 
 
Hematology 
 
Urine 
 
 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Programming note: Repeat for table 14.3.4.2 Listing of Laboratory Values with CTCAE Grade 3 or Higher (Safety Population) 
Programming note: for CTCAE Grade/ Flag, show CTCAE grade if the lab test is graded via CTCAE criteria.  If not, indicate H 
for above upper limit of normal or L for below lower limit of normal 
 
 
 


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Table 14.3.4.3 
 
Listing of Liver Function Tests of Potential Concern (Safety Population) 
 
Cohort Patient 
Test 
Name 
Sample 
date 
Rel 
Day 
Visit 
Name 
Result 
Units 
ULN 
Result 
xULN 
CTCAE 
Grade 
Clinical 
Significance 
Concurrent 
AST, ALT 
and Total 
Bilirubin 
Concurrent 
AST, ALT 
and Total 
Bilirubin, 
without ALP 
abnormality 
 
 
 
Programming Note: present data supporting table 14.3.7.  Only those lab test results should be presented.   
Programming Note: result x ULN should be the derived value (result/ULN) rounded to one decimal. 
Programming Note: Concurrent columns should indicate which abnormal results qualified for the "concurrent" flags in table 14.3.7. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Table 14.3.5.1a 
 
Summary of Hematology and Coagulation Results and Change from Baseline (Cohort 1, Safety Population) 
 
Parameter 
Stati
stic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Valu
e 
Change 
from BL 
Valu
e 
Change 
from BL 
Valu
e 
Change 
from BL 
WBC (unit) 
C1D1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
C1D8 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
C1D15 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
C1D22 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 


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min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
C2D1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
(etc for all cycle/ days for the parameter with at least 3 
Patients reported in the overall column). 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
media
n 
xx 
xx 
xx 
xx 
xx 
xx 
min - 
max 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
xx - 
xx 
xx - xx 
(etc. for all hematology parameters) 
  
  
  
  
  
  
BL = Baseline 
Note: Baseline is defined as the most recent measurement 
prior to the first administration of study drug. 
Programming note: repeat for Cohorts 2-5  
Programming note: repeat for 
Table 14.3.5.2 Chemistry 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.6.1a 
 
Hematology and Coagulation Shifts from Baseline to Worst Value on Study, Overall and by Dose Group (Cohort 1, Safety Population) 
 
Cohort 
Baseline 
Grade 
Worst Grade on Study 
Parameter 
  
Normal 
1 
2 
3 
4 
5 
Cohort 1A: FT-2102 (N=xx) 
WBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
RBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Platelets 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
(etc. for all hematology parameters) 
Cohort 1B: FT-2102+AZA (N=xx) 
WBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
RBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


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Platelets 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
(etc.) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Cohort 1: Overall (N=xx) 
WBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
RBC 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Platelets 
Normal 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
1 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
(etc.) 
4 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
  
  
  
  
  
  
  
  
Programming note: repeat for Cohorts 2-5 
Programming note: repeat for Table 14.3.6.2 Chemistry Shifts (Safety Population) 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
Note: CTCAE v 4.03 is applied to lab values. 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.7a 
 
Summary of Liver Function Tests of Potential Concern (All Patients Receiving Single Agent Therapy, Safety Population) 
 
Cohort 1A: 
Cohort 2A: 
Cohort 3A: 
Cohort 4A: 
Cohort 5: 
Overall: 
FT-2102 
FT-2102 
FT-2102 
FT-2102 
FT-2102 
 FT-2102 
Parameter 
Statistic 
(N =  ) 
(N =  ) 
(N =  ) 
(N =  ) 
(N =  ) 
(N =  ) 
ALT 
 
 
 
 
 
 
 
  ALT >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
AST 
 
 
 
 
 
 
 
  AST >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
AST,ALT 
 
 
 
 
 
 
 
  AST or ALT >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Total Bilirubin 
 
 
 
 
 
 
 
  Total Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Total Bilirubin >=2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
ALP 
 
 
 
 
 
 
 
  ALP >2.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALP >5X ULN 
 
 
 
 
 
 
 


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  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Concurrent AST, ALT and Total Bilirubin* 
 
 
 
 
 
 
 
  (AST or ALT >3X ULN) and Total 
Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  (AST or ALT >3X ULN) and Total 
Bilirubin >2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Concurrent AST, ALT and Total Bilirubin, 
without ALP abnormality** 
 
 
 
 
 
 
 
  (AST or ALT >3X ULN) and Total 
Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  (AST or ALT >3X ULN) and Total 
Bilirubin >2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the 
criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
ALT>3x ULN or AST>3x ULN with CONCURRENT 
report of selected adverse event(s)*** 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
ULN = Upper limit of normal 
Note: A Patient may be counted in more than one row. 
*Laboratory parameters must be met within +/- 7 days of those parameters to be counted as concurrent. 
** ALP must be <2x ULN for all tests drawn within +/- 7 days of the concurrent elevated AST/ALT and Bilirubin. 
***Selected adverse events: Nausea, Vomiting, Anorexia, Abdominal pain, Abdominal discomfort, Fatigue, Jaundice, Pruritus, 
Chromaturia, Faeces discoloured. 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Table 14.3.7b 
 
Summary of Liver Function Tests of Potential Concern (Safety Population) 
 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
Parameter 
Statistic 
(N =  ) 
(N =  ) 
(N =  ) 
ALT 
 
 
 
 
  ALT >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALT >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
AST 
 
 
 
 
  AST >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
AST,ALT 
 
 
 
 
  AST or ALT >3X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >10X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AST or ALT >20X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Total Bilirubin 
 
 
 
 
  Total Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Total Bilirubin >=2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ALP 
 
 
 
 
  ALP >2.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  ALP >5X ULN 
 
 
 
 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Concurrent AST, ALT and Total Bilirubin* 
 
 
 
 
  (AST or ALT >3X ULN) and Total Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 


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  (AST or ALT >3X ULN) and Total Bilirubin >2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Concurrent AST, ALT and Total Bilirubin, without ALP 
abnormality** 
 
 
 
 
  (AST or ALT >3X ULN) and Total Bilirubin >1.5X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  (AST or ALT >3X ULN) and Total Bilirubin >2X ULN 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  No post-baseline values meet the criteria 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ALT>3x ULN or AST>3x ULN with CONCURRENT report of 
selected adverse event(s)*** 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
ULN = Upper limit of normal 
Note: A Patient may be counted in more than one row. 
*Laboratory parameters must be met within +/- 7 days of those parameters to be counted as concurrent. 
** ALP must be <2x ULN for all tests drawn within +/- 7 days of the concurrent elevated AST/ALT and Bilirubin. 
***Selected adverse events: Nausea, Vomiting, Anorexia, Abdominal pain, Abdominal discomfort, Fatigue, Jaundice, Pruritus, 
Chromaturia, Faeces discoloured. 
 
Programming note: repeat for cohorts 3-5. 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.8a 
 
Summary of Vital Signs and Change from Baseline by Time Point, Overall and by Dose Group (Cohort 1, Safety Population) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Value 
Change from BL 
Value 
Change from BL 
Value 
Change from BL 
SBP (unit) 
C1D1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
C1D8 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
C1D15 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
C1D22 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
C2D1 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 


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(etc for all cycle/ 
days for the parameter 
with at least 3 Patients 
reported in the overall 
column). 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
xx - xx 
(etc. for all vital signs) 
  
  
  
  
  
  
  
BL = Baseline 
Programming note: repeat for Cohorts 2-5  
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.9a 
 
Summary of ECG Results and Change from Baseline (Cohort 1, Safety Population) 
 
 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
Parameter 
 
FT-2102 
FT-2102 + AZA 
 Overall 
Visit 
Time Point 
(N =  ) 
(N =  ) 
(N =  ) 
Value 
Change from BL 
Value 
Change from BL 
Value 
Change from BL 
QRS (unit) 
C1D1 
Pre-dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx xx - xx 
xx - xx xx - xx 
xx - xx xx - xx 
4 hours 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx xx - xx 
xx - xx xx - xx 
xx - xx xx - xx 
8 hours 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx xx - xx 
xx - xx xx - xx 
xx - xx xx - xx 
C1D2 
Pre-dose 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx xx - xx 
xx - xx xx - xx 
xx - xx xx - xx 


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(etc for all cycle/ days/ time 
points for the parameter with at 
least 3 Patients reported in the 
overall column). 
n 
xx 
xx 
xx 
xx 
xx 
xx 
mean 
xx 
xx 
xx 
xx 
xx 
xx 
SD 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
median 
xx 
xx 
xx 
xx 
xx 
xx 
min - max xx - xx xx - xx 
xx - xx xx - xx 
xx - xx xx - xx 
(etc. for all ECG parameters) 
  
  
  
  
  
  
  
BL = Baseline 
Programming note: repeat for Cohorts 2-5  
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Baseline is defined as the most recent measurement prior to the first administration of study drug. 
 
 
 
 


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Protocol 2102-ONC-102 
Table 14.3.10.1a 
 
QTcF Shifts from Baseline (Single Agent Therapy, Safety Population) 
 
  
Maximum Post-Baseline Value 
Treatment Group Baseline Value 
<=450 msec 
>450 to 
>480 to 
>500 msec 
>30 to <=60 
>60 msec 
<=480 msec 
<=500 msec 
msec Change 
Change from 
  
  
from Baseline 
Baseline 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Cohort 1 (N=xx)         <=450 msec 
  
  
  
  
  
  
>450 to <=480 msec 
  
  
  
  
  
  
>480 to <=500 msec 
  
  
  
  
  
  
         >500 msec 
  
  
  
  
  
  
             Total 
  
  
  
  
  
  
  
  
  
  
  
  
  
Cohort 2 (N=xx)         <=450 msec 
  
  
  
  
  
  
>450 to <=480 msec 
  
  
  
  
  
  
>480 to <=500 msec 
  
  
  
  
  
  
         >500 msec 
  
  
  
  
  
  
             Total 
  
  
  
  
  
  
  
  
  
  
  
  
  
Cohort 3 (N=xx)         <=450 msec 
  
  
  
  
  
  
>450 to <=480 msec 
  
  
  
  
  
  
>480 to <=500 msec 
  
  
  
  
  
  
         >500 msec 
  
  
  
  
  
  
             Total 
  
  
  
  
  
  
  
  
  
  
  
  
  
Cohort 4 (N=xx)         <=450 msec 
  
  
  
  
  
  
>450 to <=480 msec 
  
  
  
  
  
  
>480 to <=500 msec 
  
  
  
  
  


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         >500 msec 
  
  
  
  
  
  
             Total 
  
  
  
  
  
  
  
  
  
  
  
  
  
Cohort 5 (N=xx)         <=450 msec 
  
  
  
  
  
  
>450 to <=480 msec 
  
  
  
  
  
  
>480 to <=500 msec 
  
  
  
  
  
  
         >500 msec 
  
  
  
  
  
  
             Total 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Repeat for: 
Table 14.3.10.1b QTcF Shifts from Baseline (Combination Therapy, Safety Population) 
 


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Figure 14.3.10.2a 
Maximum Post Baseline QTcF vs Baseline QTcF (Single Agent Therapy, Safety Population) 
 
 
 
 
Repeat for 14.3.10.2b (Combination Therapy, Safety Population) 
 
Programming notes: 
• 
One axis represents baseline QTcF and the other axis represents maximum post-baseline QTcF.  Include unscheduled visits as 
candidates for maximum.   
• 
Color code the dots by cohort.   
• 
Add reference lines for QTcF of 450, 480, and 500 on both axes. 
 


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Protocol 2102-ONC-102 
Table 14.3.11a 
Concomitant Medications (Cohort 1) 
 
Parameter 
Statistic 
Cohort 1A: 
Cohort 1B: 
Cohort 1: 
FT-2102 
FT-2102 + AZA 
 Overall 
(N =  ) 
(N =  ) 
(N =  ) 
Drug class 1 
n (%) 
ATC text 1 
n (%) 
ATC text 2 
n (%) 
ATC text 3 
n (%) 
etc. 
n (%) 
Drug class 2 
n (%) 
ATC text 1 
n (%) 
ATC text 2 
n (%) 
ATC text 3 
n (%) 
etc. 
n (%) 
  
  
  
  
  
 
 
Repeat for Cohorts 2-5 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
Note: Patients are counted once per drug class and ATC. Concomitant Medications are coded with the WHO Drug version March 2018. 
 


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10. 
DATA LISTING SHELLS 


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Protocol 2102-ONC-102 
Listing 16.2.1.1 
 
Study Completion Status 
 
 
Cohort 
Patient 
First Dose 
Date of FT-
2102 
Last Dose 
Date of FT-
2102 
Last Dose Rel 
Day 
Reason for 
Terminating 
Treatment 
Reason for 
Terminating 
Study 
Date of 
Last 
Contact 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 
 
 


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Listing 16.2.1.2 
 
Pre-Screening Consent 
 
Cohort 
Patient 
Pre-Screening 
Consent 
IDH1 Mutation 
Result 
Consent Date for 
Archival Tumor Tissue 
Date of Tissue 
Collection 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.1.3 
 
Enrollment 
Cohort 
Patient 
Screen Failure 
Study Phase 
and Stage 
Safety Lead In 
Pharmaco-
genomics Consent 
Consent for C3 Tumor 
Tissue Sample 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.2.1 
 
Inclusion and Exclusion Criteria 
 
Cohort 
Patient 
Informed 
Consent Date 
Protocol Version 
Consented 
Inclusion/ Exclusion Criteria Not Met 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.2.2 
 
Protocol Violations 
 
Cohort 
Patient 
Violation 
Severity 
Violation 
Category 
Violation Description 
  
Major 
Minor 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.3.1 
 
Analysis Sets 
 
Cohort 
Patient 
DLT Evaluable Set 
Safety Set 
Response 
Evaluable Set 
PK Set 
PD Set 
 
 
 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.1 
 
Demographics and Baseline Information 
 
 
Cohort 
Patient 
Age at 
Consent 
Height (cm) 
Sex at Birth 
Child Bearing 
Potential 
Ethnicity 
Race 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.2 
 
Baseline Disease Data and Cancer Diagnosis 
 
 
Initial 
Current 
Cohort Patient Diagnosis 
Diagnosis 
Date 
Grade Stage 
TNM 
Stage 
  Diagnosis 
Recurrence 
Date 
Grade Stage 
TNM 
Stage 
Fibrosis 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.3 
 
IDH1 and Other Mutations 
 
IDH Mutation 
Cohort 
Patient 
Sample Date 
Method 
Site of Tissue 
Result 
IDH Mutation 
Other Mutations 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.4 
 
Medical History 
 
 
Cohort 
Patient 
Start Date 
Verbatim Term 
SOC 
PT 
CTC Grade 
End Date 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Medical Histories are coded with the MedDRA version 21.0. 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.5 
 
Prior Anti-Cancer Therapies 
 
Cohort 
Patient 
Regimen 
Therapy Name/ 
WHO Drug Name 
Therapy Type/ 
WHO Drug 
Class 
 
Start Date/ 
End Date 
Best Response 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
Note: Prior anti-cancer therapy medications are coded with the WHO Drug version March 2018. 
 
Programming notes:  
• 
For Best Response, abbreviate responses as: CR, PR, MR, SD, PD, ND, UN 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.6 
 
Prior Radiotherapy 
 
 
Cohort 
Patient 
Type of 
Radiation 
Start Date 
End Date 
Dose 
Unit 
Location 
Best 
Response 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Protocol 2102-ONC-102 
Listing 16.2.4.7 
 
Major Surgical Tumor Resections 
 
Cohort 
Patient 
Surgical Procedure Description 
Location 
Procedure Date 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Child Pugh Score 
 
 
Cohort 
Patient 
Assessment 
Date 
Total 
Bilirubin 
Serum 
Albumin 
INR 
Ascites 
Hepatic 
Encepal-
opathy 
Child Pugh 
Score 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Hepatitis B and C 
 
 
Hepatitis B   
Hepatitis C   
Cohort 
Patient 
Assessment Date 
Assessment Time 
Method of Assessment 
Result 
Titer 
Unit 
  
Result 
Titer 
Unit 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Archival Tumor Tissue 
 
 
Cohort 
Patient 
Collection Date  
Sample Type 
Tissue Site 
Was the sample sent to the 
lab? 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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FT-2102 Administration 
 
Cohort 
Patient 
Start Date 
(Rel Day) 
End Date 
(Rel Day) 
Assigned 
Dose 
Frequency 
Actual 
Total Daily 
Dose 
Dose 
Modification 
Reason 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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FT-2102 Drug Accountability 
 
 
Dispensed 
Returned 
Taken per Pt Diary 
Cohort Patient Cycle 
50 mg 
Capsules 
150 mg 
Capsules 
50 mg 
Capsules 
150 mg 
Capsules 
50 mg 
Capsules 
150 mg 
Capsules 
Total 
Dose 
Taken 
(mg) 
Total Dose 
Not Taken 
and Not 
Returned 
(mg) 
Percent 
Compliance 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Azacitidine, Nivolumab, Cisplatin, and Gemcitabine Administration 
 
 
Cohort 
Patient 
Drug 
Cycle/ 
Time 
Point 
Dosing 
Date 
(Rel 
Day) 
Start/ 
Stop 
Time 
Assigned 
Dose 
(Unit)/ 
Route 
Prepared 
Dose 
(mg) 
Volume of 
Prepared 
Dose (mL) 
Volume 
Admin-
istered 
(mL) 
Dose 
Modification/ 
Reason 
Interruption/ 
Reason/ Start 
Time/ Stop 
Time 
Azacitidine 
Nivolumab 
Cisplatin 
Gemcitabine 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Pharmacokinetic Concentrations 
 
 
 
Cohort 
Patient 
Visit 
Sample Date 
Rel Day 
Value 
Laboratory Comments 
 
 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Pharmacokinetic Parameters 
 
 
Cohort 
Patient 
- 
Cmax 
Tmax 
Thalf 
AUC 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY 
 
 
 


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Target Lesions (RECIST) 
 
Cohort 
Patient 
Visit 
Imaging 
Date (Rel 
Day) 
Lesion 
Number 
Lesion 
Location/ 
Description 
Method of 
Measurement & 
Contrast 
Lesion 
State 
Assessment 
Result 
Longest 
Diameter 
(mm) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Non-Target and New Lesions (RECIST) 
 
Cohort 
Patient 
Visit 
Imaging 
Date 
(Rel 
Day) 
Lesion 
Number/ 
New 
Lesion 
Lesion 
Location/ 
Description 
Method of 
Measurement & 
Contrast 
Lesion 
State 
Assessment 
Result 
Longest 
Diameter/ 
Short Axis 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Measurable Lesions (RANO) 
 
Cohort Patient Visit 
Imaging 
Date 
(Rel 
Day) 
Lesion 
Number 
Lesion 
Location 
Category 
Location 
Description 
Method of 
Measurement 
& MRI 
Details 
Lesion 
Assessment 
Result 
Longest 
Diameter 
(mm) 
Perpendicular 
Measurement 
(mm) 
Lesion 
Area 
(mm^2) 
Cerebrum 
Print 
Location 
Cerebellum from nodal  
Brainstem 
location or  
Spine 
extranodal  
Other 
location 
and  
location  
description 
fields 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Non-Measurable and New Lesions (RANO) 
 
Cohort Patient Visit 
Imaging 
Date 
(Rel 
Day) 
Lesion 
Number/ 
New 
Lesion 
Lesion 
Location 
Category 
Location 
Description 
Method of 
Measurement 
& MRI 
Details 
Lesion 
Assessment 
Result 
Longest 
Diameter 
(mm) 
Perpen-
dicular 
Measurement 
(mm) 
Lesion 
Area 
(mm^2) 
Cerebrum 
Print 
Location 
Cerebellum from nodal  
Brainstem 
location or  
Spine 
extranodal  
Other 
location 
and  
location  
description 
fields 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Response Assessment (RECIST) 
 
Cohort 
Patient 
Visit 
Assessment 
Date (Rel 
Day) 
Target 
Lesion 
Response 
Non-
Target 
Lesion 
Response 
New 
Lesions 
Overall 
Response 
Best 
Overall 
Response 
Progression 
Date (Rel 
Day) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Protocol 2102-ONC-102 
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Response Assessment (RANO) 
 
Cohort Patient Visit 
Assessment 
Date (Rel 
Day) 
Measurable 
Lesion 
Response 
Non-
Measurable 
Lesion 
Response 
New 
Lesions 
Steroid 
Status 
Clinical 
Status 
Overall 
Response 
Best 
Overall 
Response 
Progression 
Date (Rel 
Day) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Response Assessment (Cheson) 
 
Cohort 
Patient 
Visit 
Assessment 
Date (Rel 
Day) 
Sum of the 
Product 
Diameters 
(mm^2) 
Measurable 
Lesion 
Response 
Non-
Measurable 
Lesion 
Response 
New 
Lesions 
Overall 
Response 
Best 
Overall 
Response 
Progression 
Date (Rel 
Day) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Survival Status 
 
Cohort 
Patient 
Date Last 
Known Alive 
(Rel Day) 
Patient Status at 
Time of Follow Up 
Disease Progression 
Not Previously 
Reported? 
Treated with Anti-
Cancer Therapy for 
Disease? 
Start Date of New 
Treatment (Rel 
Day) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Serum AFP, CA-19-9, and CEA 
 
Cohort 
Patient 
Visit 
Date of 
Sample 
Rel Day 
Serum AFP 
Value 
CA19-9 Value 
CEA Value 
Laboratory 
Comments 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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EQ-5D-5L Quality of Life Assessment 
 
Cohort 
Patient 
Visit 
Assessment 
Date (Rel Day) 
Mobility 
Self 
Care 
Usual 
Activities 
Pain/ 
Discomfort 
Anxiety/ 
Depression 
Your 
Health 
Today 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 


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2-HG MRS Assessments 
 
 
Cohort 
Patient 
Visit 
Assessment 
Date 
Rel Day 
2-HG Value 
Imaging Reader Comments 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Archival Tumor Tissue and Biopsy 
 
 
Cohort 
Patient 
Visit 
Sample Collection 
Date 
Rel Day 
Sample Type 
Tissue Collection 
Site 
Sample Sent 
to Lab? 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Pharmacogenomics Samples 
 
 
Cohort 
Patient 
Visit 
Pharmacogenomics Sample 
Collected? 
Sample Date 
Rel Day 
Sample Time 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Adverse Events by Patient and Verbatim Term 
 
Cohort Patient 
Verbatim 
Term 
Preferred 
Term 
Start Date 
(Rel Day) 
Stop Date 
(Rel Day) 
CTCAE 
Grade 
SAE Outcome 
Relationship 
to Drug1 
Action 
Taken 
with 
Study 
Drug2 
Other 
Action 
Taken 
Programming Note: Sort by cohort, Patient, start date, and preferred term 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
Note: Adverse Events are coded with the MedDRA version 21.0. 
Note:The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 


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Adverse Events by Patient and MedDRA System Organ Class and Preferred Term 
 
Cohor
t 
Patien
t 
System Organ 
Class 
Preferred 
Term 
Start 
Date (Rel 
Day) 
Stop 
Date 
(Rel 
Day) 
CTCAE 
Grade 
SA
E 
Outcom
e 
Relationshi
p to Drug1 
Actio
n 
Taken 
with 
Study 
Drug2 
Other 
Actio
n 
Taken 
Programming Note: Sort by cohort, Patient, system organ class, preferred term, and start 
date. 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
Note: Adverse Events are coded with the MedDRA version 21.0. 
Note:The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 
 
 


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Adverse Events by MedDRA System Organ Class, Preferred Term, Cohort, and Patient 
 
System Organ 
Class 
Preferred Term Cohort Patient 
Start Date 
(Rel Day) 
Stop 
Date 
(Rel 
Day) 
CTCAE 
Grade 
SAE Outcome 
Relationship 
to Drug1 
Action 
Taken with 
Study 
Drug2 
Other 
Action 
Taken 
Programming Note: Sort by system organ class, preferred term, cohort, Patient, and start date. 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
Note: Adverse Events are coded with the MedDRA version 21.0. 
Note:The combination drug is Azacitidine in cohort 1b and 3b, Nivolumab in cohort 2b, and Gemcitibine + Cisplatin in cohort 4b. 
1 Relationship to Drug: None, REM = Remote, POS= Possible, PROB= Probable, DEF= Definite and NA= Not Applicable 
2 Action Taken with Study Drug: None = Dose Not Changed; INT = Dose Interrupted; RED = Dose Reduced; WD = Drug Withdrawn. 
 
 
 
 
 


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Laboratory Results: Hematology 
 
Cohort 
Patient 
Test Name 
Sample date 
(Rel Day) 
Visit 
Name 
Result 
Units 
LLN 
ULN 
CTCAE 
Grade/ 
Flag 
Clinical 
Significance 
Programming note: for CTCAE Grade/ Flag, show CTCAE grade if the lab test is graded via CTCAE 4.03 criteria.  If not, 
indicate H for above upper limit of normal or L for below lower limit of normal 
Programming note: repeat for 16.2.8.2, 16.2.8.3, 16.2.8.4, 16.2.8.6 
Programming note: tests that should be in 16.2.8.6 include TSH testing, pregnancy, and Hepatitis B and C testing 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Laboratory Normal Ranges 
 
Laboratory Name 
Start Date 
Stop Date 
Gender 
Age Category 
LLN 
ULN 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Vital Signs 
 
Cohort Patient Visit 
Assessment Date 
(Rel Day) 
Assessment 
Time 
Weight 
(kg) 
 
Temperature 
( C) 
Pulse 
(beats/min) 
Respiratory 
Rate 
(breaths/mim) 
SBP 
(mmHg) 
DBP 
(mmHg) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Physical Examination 
 
 
Cohort 
Patient 
Visit 
Assessment Date 
Rel Day 
Overall 
Assessment 
If Abnormal, Was 
Abnormality Present at 
Screening 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Electrocardiogram Results 
 
Cohort Patient Visit 
Assessment Date 
(Rel Day) 
Time 
Point 
Time of 
ECG 
ECG # 
PR 
HR QRS QT QTcF 
Overall 
Evaluation/ 
Clinical 
Significance 
Abnormal, 
Specify 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Prior and Concomitant Medications 
 
Cohort 
Patient 
Medication 
WHO 
Drug 
Class 
ATC Text 
Reason for 
Medication/ 
Indication 
Dose 
and 
Units 
Frequency 
Route 
Start 
Date 
(Rel 
Day)/ 
Stop 
Date 
(Rel 
Day) 
Prior/ Concomitant 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
Note: Prior and Concomitant Medications are coded with the WHO Drug version March 2018. 
 
 
 


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Concomitant Procedures 
 
 
Cohort 
Patient 
Procedure 
Reason for 
Procedure 
Location 
Procedure Date 
Rel Day 
 
 
Note: sort by cohort, Patient, and procedure date. 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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Systemic Steroid Dosing 
 
Cohort 
Patient 
Medication 
WHO Drug 
Class 
ATC Text 
Dose and 
Units 
Frequency 
Route 
Start Date 
(Rel Day)/ 
Stop Date 
(Rel Day) 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY
 
 
 
 


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ECOG Performance Status 
 
 
Cohort 
Patient 
Visit 
Assessment 
Date 
Rel Day 
ECOG Performance Status 
 
 
 
 
 
PROGRAM NAME: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
DATE: HH:MM/DDMMMYYYY


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11. 
REVISION HISTORY 
Version/ Date 
Revisions 
1.0/  05MAR2019 
First version 
2.0/ 28JUN2019 
Update SAP to align with version 3.0 of the protocol.  Edit PK 
analysis details, minor edits/ clarifications to table shells, add QTcF 
figure, clarify handling of missing date parts, edit criteria for liver 
function test summary table. 


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12. 
STUDY SCHEMATIC 
 
 
 




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Combo A=FT-2102 + 5-azacitidine; Combo B=FT-2102 + PD-1 inhibitor (nivolumab); Combo C=FT-2102 + GemCis; Chondro=chondrosarcoma; DLT=dose limiting toxicity; HBC=hepatobiliary 
cancer; IHCC=intrahepatic cholangiocarcinoma; mut=mutation; SA=single-agent FT-2102. 
Combination therapy in cohorts 1-4 may also be examined in the event that the single agent cohort passes the futility analysis and the enrollment in the single agent cohort is completed Up to 
6 patients with relapsed or refractory non-CNS solid tumors harboring an IDH1 R132X mutation in exploratory Cohort 5a will be treated with single-agent FT-2102.