A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Phase: PHASE1
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
Sponsor: Forma Therapeutics, Inc.

Protocol 2102-ONC-102 
FORMA Therapeutics, Inc. 
FT-2102  
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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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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 
 
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FT-2102  
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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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FT-2102  
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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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FT-2102  
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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 

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FT-2102  
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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) 

Protocol 2102-ONC-102 
 
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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 
measurable disease per disease appropriate response criteria 

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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 
following last dose of nivolumab if applicable) the SAE must be reported as described above.  

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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. 
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Birendra KC, DiNardo CD. Evidence for clinical differentiation and differentiation syndrome in 
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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. 
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El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular 
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Frankel SR, Eardley A, Lauwers G, et al. The "retinoic acid syndrome" in acute promyelocytic 
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Ishii Y, Sigel C, Lowery MA, et al. AG-120 (ivosidenib), a first-in-class mutant IDH1 inhibitor, 
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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 
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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