A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase: PHASE1
Conditions: Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Protocol #: FN-1501-UP1  
 
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Clinical Study Protocol  
Protocol Title: 
A phase 1, multi-center, open-label, single-arm, 
dose-escalation, clinical study to evaluate the safety, 
tolerability, pharmacokinetics (PK) and anti-tumor 
activity of FN-1501 monotherapy in patients with 
advanced solid tumors or relapsed/refractory Acute 
Myeloid Leukemia (AML) 
 
 
Protocol Number: 
FN-1501-UP1 
Investigational Drug: 
FN-1501 
 
 
Sponsor: 
Shanghai Fosun Pharmaceutical Development Co., Ltd. 
 
 
 
Version: 
Amendment 4 
Version Date: 
August 21, 2019 
 
 
CONFIDENTIAL 
All information in this protocol is confidential and is the property of the sponsor. 
 
 
 

2019.8.23

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Signature of the Investigator 
The signatory agrees to the content of the final clinical study protocol as presented. 
 
Name:                         Study site:                           
Date:                          Signature:                           
 
 
 

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PROTOCOL AMENDMENT, VERSION 4 
Amendment rationale 
Protocol FN-1501-UP1 is updated: 
o Inclusion criteria: To clarify that laboratory requirements for complete blood 
counts (hemoglobin, ANC, and platelets) do not apply to AML patients. 
o To clarify the maximum number of patients per cohort from six to four: 
“Additional patient(s), up to a maximum of four (4) patients in total, may be 
enrolled in a cohort if more than three (3) have been screened and are eligible 
for the cohort.” 
o Clarified that PK samples are taken “prior to that days dose (if applicable)” 
o Moved in text reference citations to references (Section 13).  
o Updated abbreviations and other typographical edits. 
o Added signature for Ai-Min Hui, Global Chief Medical Officer 
Section 7.1.3 (Electrocardiogram), updated text to match footnotes from Table 2.  
Section 7.1.4 (Computed Tomography), clarified that CT scans do not apply to 
patients with AML.  
Section 7.4 (Efficacy), to provide details for bone marrow biopsy and related 
assessments for patients with AML, added the following: Under amendment rationale 
for Version 3, “add the specific population” was revised to read “AML”.  
To include in the bone marrow assessments:  
 Bone marrow cellularity 
 Total cells counted 
 Blasts in marrow 
 Classical cytogenetic analysis 

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PROTOCOL AMENDMENT, VERSION 3 
Amendment rationale 
Protocol FN-1501-UP1 is updated: 
o To include patients with relapsed/refractory Acute Myelocytic Leukemia 
(AML) 
Rationale in Acute Myeloid Leukemia:   
Patients with AML have a clear need for new therapeutic options. Preclinical 
data from in vivo studies suggest that FN-1501 as a single agent could offer 
cancer patients clinical benefit by inhibiting multiple tyrosine kinases including 
FMS-like tyrosine kinase 3 (FLT3), mutations of which are associated with 
leukemic transformation, and are present in up to 30% of this patient population. 
Considering that AML is not an ideal for a first in human study due to its rapid 
natural history and the risk of under-dosing the patients leading to rapid 
progression, the first in human study of FN-1501 only included patients with 
histologically or cytologically confirmed advanced solid tumors. Currently, this 
ongoing clinical trial has treated 9evaluable patients with solid tumors that 
completed the dose limiting toxicity (DLT) period in three cohorts of ascending 
doses, including 2.5 mg, 5.0 mg, and 10 mg. Cohort 4 at 15 mg is on-going. No 
DLTs have been reported.  
As the ongoing study is approaching the expected efficacious range for 
FN-1501, which has been estimated at 15-30 mg daily (based on preclinical 
data), we are amending the protocol to include the target patient population 
(AML) in the Study FN1501-001. Patients with AML that have no standard 
therapeutic options enrolled in this clinical trial will not be treated at sub-
therapeutic doses and patients may receive clinical benefit since an active dose 
is expected. 
o To modify the life expectancy of enrolled patients to at least three months 
o To modify dose escalation rules. Increases of doses of FN-1501 will be set at 
33% after 30 mg/day dose to have a traditional escalation scheme with 
meaningful change (currently the dose escalation is 16%) until the maximum 
tolerated dose (MTD) is reached 

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o To include a pharmacokinetic (PK) sample at steady state on Day 1 of Cycle 2 
o To add DLT definitions for patients with AML 
o To include evaluation criteria for patients with AML 
o To modify the frequency of evaluation criteria for patients with solid tumors to 
every 6 weeks to align with the study-drug treatment schedule 
o To include bone marrow biopsy in patients with AML 
o To clarify electrocardiogram (ECG) procedures 

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PROTOCOL AMENDMENT, VERSION 2.2 
Amendment rationale 
Protocol FN-1501-UP1 is updated: 
o To clarify serious adverse event (SAE) report procedure 
o To revise wording for clarity and consistency 
Changes to the protocol 
o Sentence was added in Section 7.1.1 Local Laboratory Evaluation to specify 
that PI is responsible to assess lab test results. 
o PK sampling schedule for additional PK was added in Section 7.5 
Pharmacokinetics. 
o “(usually involving at least an overnight stay)” was removed from Section 9.2 
Definition of a SAE to include SAE without overnight stay. 
o Section 9.8.2 Completion and Transmission of the SAE Report was updated to 
specify that the primary SAE report method is through an electronic case 
report form (eCRF) system, instead of paper form. 
o Other editorial changes. 

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PROTOCOL AMENDMENT, VERSION 2.1 
Amendment rationale 
Protocol FN-1501-UP1 is updated: 
o To clarify safety monitoring terms and procedure 
o To specify the time window for assessments 
o To revise wording for clarity and consistency 
Changes to the protocol 
o “Subject” was changed to “patient” through the protocol. 
o Section 1.1 Background and Pharmacology was updated. 
o Section 4.1.3 Study Procedure was added to separate some content from 
Section 4.1.2. 
o Table 2 was updated; time windows for PK sampling, ECG and vital sign were 
added after Table 3. 
o The sentence about pregnancy test results was changed to “The results of 
pregnancy texts will be recorded in the database” in Section 7.2.2.1 Pregnancy 
testing. 
o AE/SAE causality categories were added in Section 9.6.2. 
o Other editorial changes 

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PROTOCOL AMENDMENT, VERSION 2 
Amendment rationale 
Protocol FN-1501-UP1 is updated: 
o to revise DLT definition for clarity  
o to revise inclusion/exclusion criteria for clarity 
o to specify study stopping criteria 
o to specify treatment delay/interruption rule 
o to specify DLT criteria for liver toxicity 
o  to add serum amylase and lipase tests 
Changes to the protocol 
Changes to specific sections of the protocol are shown in the track changes version.  
Synopsis: 
o Revised inclusion criteria #3 to “Patients with histologically or cytologically 
confirmed advanced solid tumors who have relapsed or refractory disease for 
which no standard therapies expected to produce clinical benefit to the patient 
are available”. 
o Revised inclusion criteria #10 to “Men who are engaging or plan to engage in 
sexual activity with a female of childbearing potential must either have a prior 
vasectomy or agree to use effective contraception such as condoms, sexual 
abstinence, or appropriate methods taken by partner during the study and for 
90 days after the last dose” 
o Revised exclusion criterion #20 to “On medications that are strong 
cytochrome P450 (CYP)3A inhibitors or inducers unless patients are willing 

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and able to change to use of an equivalent medication that is not a strong 
CYP3A inhibitor or inducer”. 
Section 4.1.1: Dose Escalation 
o Removed “The study will be discontinued in the event of any new findings 
that indicate a relevant deterioration of the risk-benefit relationship that would 
render continuation of the study unjustifiable.” And re-wrote it in 
Section 4.1.3. 
o Replaced “DLT is any adverse effect attributable to study drug that meets the 
following criteria, as determined by investigators based on NCI-CTCAE 
Version 4.03” with the following “DLT is any adverse event not attributable to 
disease or disease-related processes that occur during the DLT observation 
period. DLT is determined by investigators based on NCI-CTCAE 
Version 4.03”. 
o Replaced “Abnormal liver function test results defined as AST/ALT ≥ 3 ULN 
and total bilirubin ≥ 2 ULN for subject without liver metastasis” with the 
following: “For elevations in hepatic function enzymes, DLT is defined as 
follows: 
• Grade 4 AST or ALT increase  
• AST or ALT > 5 x ULN if accompanied by ≥ Grade 2 elevation in 
bilirubin 
• AST or ALT > 5 x ULN lasting > 3 days in patients without liver 
metastases 
• AST or ALT > 5 x ULN lasting > 3 days if the baseline value was ≤ 3 x 
ULN in patients with liver metastases 
• AST or ALT > 8 x ULN lasting > 3 days if the baseline value was > 3 x 
ULN but < 5 x ULN in patients with liver metastases” 
Section 4.1.2: Continuous Treatment 
o Updated Table 2: Study Assessment and Procedure Schedule. 
Section 4.1.3: Study Stopping Rules 

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• Added a section to specify study stopping rules. 
Section 4.2.1: Inclusion Criteria 
• Revised inclusion criteria #3 and #10 for consistency with the synopsis. 
Section 4.2.2: Exclusion Criteria 
• Revised exclusion criterion #20 for consistency with the synopsis. 
Deleted original Section 4.2.4: Dose Adjustment 
Section 4.2.5: Subject Completion and Discontinuation became Section 4.2.4 
• Updated Section 4.2.4.2: Subject Discontinuation and added the following 
paragraph “A subject must be discontinued if any one or more of the 
conditions occur: 1) DLT occurs and the toxicity is not improved to 
Grade 1, Grade 0 or baseline within 14 days of onset; 2) occurrence of 
other toxicities that makes continuation of study treatment intolerable; 3) a 
third dose-reduction is required; 4) treatment delay is more than 4 weeks, 
unless resuming treatment is regarded beneficial to the subject by the 
investigator and agreed by Sponsor’s medical monitor; 5) in the opinion of 
the investigator, continuous treatment is not beneficial to the subject.” 
Section 5.2.1: Dose Delays and Modifications 
• Added a section to specify dose delays and modifications. 
Section 7.1.1: Local Laboratory Evaluation 
• Added serum amylase and lipase tests in Table 6. Clinical Laboratory 
Assessment. 
Appendix 1: Signature of Investigator   
• Updated protocol title for consistency 

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Synopsis 
Title: 
 
 
A phase 1, multi-center, open-label, single-arm, dose-escalation, 
clinical study to evaluate the safety, tolerability, 
pharmacokinetics (PK) and anti-tumor activity of FN-1501 
monotherapy in patients with advanced solid tumors or in 
relapsed/refractory Acute Myeloid Leukemia (AML) 
Investigational 
drug: 
FN-1501 lyophilized powder 
Protocol No. 
FN-1501-UP1 
Clinical phase: 
Phase 1 
Number of 
patients: 
Estimated 33 evaluable patients  
Number of sites 
and locations: 
3 sites in the United States (US) and Australia 
Study cycle: 
Screening period: Day -21 to Day -1. 
Treatment period: In the first cycle, a single dose of study drug 
will be administered three times a week on Days 1, 3, 5, 8, 10, 
and 12, with the last week off study drug (total 21 days). 
Subsequent treatment cycles will be 21 days and the study drug 
will be administered with the same dose and the same schedule 
as the first cycle. 
Follow-up period: 30 days after the last dose. 
Objectives  
Primary 
To evaluate the safety and tolerability of FN-1501 
To determine the maximum tolerated dose (MTD) and 
recommended phase 2 dose (RP2D) 
Secondary 
To characterize the PK of FN-1501 and major metabolites 
To describe the preliminary anti-tumor activity of FN-1501 
Study design: 
This is a phase 1, first-in-human, open-label, multi-center, single-arm, dose 
escalation clinical study in patients with histologically or cytologically confirmed 
advanced solid tumors or relapsed/refractory AML, who cannot tolerate or do not 
respond to standard systemic therapy. It aims to determine the MTD and RP2D, 
evaluate the safety, tolerability, PK characteristics, and the preliminary anti-tumor 
activity of FN-1501. 

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Eligible patients will receive a single intravenous infusion of study drug on Days 1, 
3, 5, 8, 10, and 12 of a 21-day cycle. Dose limiting toxicity (DLT) assessment 
period is the first cycle of study treatment.  
Starting dose, dose escalation scheme, and stopping criteria 
 Dosing will begin at 2.5 mg once per day on the assigned days.  
 Dose escalation will use the traditional 3+3 design and follow a modified 
Fibonacci sequence until MTD is reached. Increments of 33% in the dose of 
FN-1501 will be undertaken after reaching 30 mg/day. Because of the 
dosage form (10 mg/vial), each dose will be rounded up or down to levels 
such as 2.5, 5, 10, 22.5 mg/day, etc. At least 3 patients will be enrolled in 
each cohort. Dose escalation or de-escalation will be determined by the 
number of DLTs in each cohort. 
 The highest dose under which one or no case of DLT is observed will be 
considered as MTD. If DLT cannot be observed, RP2D will be determined 
based on safety, preliminary anti-tumor activities and PK data.  
 Additional patients will not start the treatment until 48 hours after the 1st 
dosing of the 1st patient in the same cohort. 
 Approximately thirty-three patients are expected to be enrolled. 
Continuous Treatment: A continuous treatment cycle is defined as 3 times a week 
for 2 weeks followed by 1-week rest. Each cycle is 21 days. Administration of 
FN-1501 will be continued until disease progression, intolerable toxicity, 
withdrawal of consent, or termination according to the Principal Investigator’s 
judgment or at the sponsor’s request. 
Population: 
Patients with histologically or cytologically confirmed advanced 
solid tumors or relapsed/refractory AML, who cannot tolerate or 
do not respond to standard therapies, or for whom no standard 
therapy exists.   
Inclusion 
criteria: 
Each patient must meet all the inclusion criteria for this study at 
the time of initial treatment: 
1. Male and female 18 years old and above 
2. Able to understand and sign informed consent form 
3. Patients with histologically or cytologically 
confirmed advanced solid tumors who have relapsed 
or refractory disease or relapsed/refractory AML for 
which no standard therapies expected to produce 
clinical benefit to the patient are available 

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4. Patients with diagnosed solid tumors must have at 
least one lesion that is measurable per Response 
Evaluation Criteria in Solid Tumors (RECIST) v1.1 
criteria 
5. Patients with relapsed or refractory AML must be 
diagnosed with AML based on World Health 
Organization (WHO) criteria (≥ 20% blasts in bone 
marrow). Patients with acute promyelocytic leukemia 
are excluded  
6. Eastern Cooperative Oncology Group (ECOG) 
Performance Status 0 or 1 
7. Have discontinued all previous cancer therapies for at 
least 21 days (for solid tumors) or at least 7 days (for 
AML) or 5 half-lives prior to study treatment, 
whichever is shorter, and recovered from the acute 
adverse effects of therapy 
8. Expected to survive at least 2 to 3 months 
9. Left ventricular ejection fraction (LVEF) ≥ 50% and 
QTc interval < 450 ms 
10. Women shall meet either of the following conditions 
before enrollment 
- 
Infertile (see Section 4.2.1) 
- 
For those of childbearing potential, they should 
have a negative serum pregnancy test during the 
screening, agree to refrain from lactation, and use 
effective contraception such as hormonal methods 
associated with inhibition of ovulation, condom, 
intra-uterine device, surgical sterilization 
(including partner’s vasectomy) or sexual 
abstinence during the study and for 30 days after 
the last administration of study drug 
11. Men who are engaging or plan to engage in sexual 
activity with a female of childbearing potential must 
either have a prior vasectomy or agree to use effective 
contraception such as condoms, sexual abstinence, or 
appropriate methods taken by their partner(s) during 
the study and for 90 days after the last dose 

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12. Patients must have adequate organ functions as 
indicated by the following screening laboratory 
values: 
- 
Serum total bilirubin ≤ 1.5 × upper limit normal 
(ULN) (Serum total bilirubin can be ≤ 3.0 × ULN 
if patients have hemolysis or congenital hemolytic 
diseases) 
- 
Creatinine < 1.5 × ULN or estimated creatinine 
clearance ≥ 50 mL/min 
- 
Aspartate aminotransferase (AST) and alanine 
aminotransferase (ALT) ≤ 2.5 × ULN (AST and 
ALT can be ≤5 × ULN for patient with liver 
metastases) 
- 
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 
- 
Platelets ≥ 100 × 109/L 
- 
Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (Note: 
Criteria must be met without a transfusion within 
2 weeks of obtaining the sample) 
Note:  Laboratory requirements for complete blood 
counts (hemoglobin, ANC, and platelets) do not apply 
to AML patients 
Exclusion 
criteria: 
Patients who meet any of the following exclusion criteria are 
not eligible to participate in this study: 
1. Participation in another therapeutic clinical trial 
within 3 weeks of enrollment 
2. A previous toxicity-related reaction towards cancer 
therapy have not recovered within 2 weeks of 
enrollment (>Grade 2 National Cancer Institute-
Common Terminology Criteria for Adverse Events 
(NCI-CTCAE) Version 4.03) 
3. Having received a major surgical operation within 
4 weeks of enrollment or not yet completely 
recovered from a previous operation  
4. Any serious or uncontrollable systemic disease, 
including but not limited to: Hypertension (after 
treatment, systolic blood pressure (SBP)  
> 180 mmHg and/or diastolic blood pressure 
(DBP) > 100 mmHg) and active hemorrhagic 

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disorders; patients who are determined by 
investigators as otherwise not suitable for 
participation in this study. Note: Patients that in the 
judgment of the investigator have clinical signs of 
disease progression during the screening period 
(i.e.: febrile neutropenia, ascites requiring drainage, 
hospitalization due to worsening underlying disease, 
etc.) will not be eligible for participation. 
5. Active known infection, including hepatitis B, 
hepatitis C, and human immunodeficiency virus 
6. Primary central nervous system (CNS) tumor or 
CNS metastases, as indicated by clinical symptoms, 
cerebral edema, and/or progressive growth (patients 
with a history of CNS metastases or cord 
compression are allowable if they have been 
definitively treated and have been clinically stable 
for at least 3 months, and off steroids or 
anticonvulsants ≥ 2 weeks before first dose of study 
drug) 
7. Serious kidney injury, requiring dialysis 
8. Serious liver injury, and advanced liver diseases of 
Child-Pugh class B and C 
9. On medications that are strong cytochrome P450 
(CYP)3A inhibitors or inducers unless patients are 
willing and able to change to use of an equivalent 
medication that is not a strong CYP3A inhibitor or 
inducer 
10. Cardiac function and disease history which meets 
one or more of the following conditions: 
- 
Any risk which may increase QTc interval 
prolongation, such as hypokalemia, hereditary 
long QT syndrome and taking drugs that can 
prolong QT interval 
- 
Acute myocardial infarction ≤ 6 months prior to 
Day 1 
- 
Clinically significant arrhythmia ≤ 6 months 
prior to Day 1 

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- 
Congestive heart failure ≥ Grade 3 by New York 
Heart Association (NYHA) ≤ 6 months prior to 
Day 1 
- 
Cerebral vascular accident (CVA) ≤ 6 months 
prior to Day 1 
11. Are pregnant or breastfeeding  
Investigational 
drug and 
dosage and 
administration 
FN-1501 lyophilized powder 
Strength:10 mg/vial 
Possible dose levels: 2.5, 5, 10, 15, 22.5, 30, and 40 mg per day. 
Administration: 10 mg/vial FN-1501 will be diluted in 10 mL 
5% glucose and added in 100 mL 5% glucose for intravenous 
infusion. Intravenous infusion should be completed within 
1 hour. 
Reference 
therapy 
Not applicable 
Criteria for Evaluation: 
Primary Endpoints 
The safety of FN-1501 will be assessed throughout the study by monitoring adverse
events (AEs) and serious adverse events (SAEs) per the NCI CTCAE Version 4.03, 
physical examination, and laboratory measurements.  
The MTD of FN-1501 will be the highest dose under which one or no case of DLT 
is observed while the RP2D of FN-1501 will be determined based on PK, safety and 
tolerability, and preliminary efficacy. 
Secondary Endpoints 
Blood sample collection: 
 Cycle 1 Day 1: pre-dose, post dose 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, and
48 hours, and on Day 8 prior to that days dose (if applicable) 
PK for a single dose profile: area under the plasma concentration-time curve from 
zero to the last measurable concentration (AUC0-last), area under concentration-time 
curve from 0 to 24 hours (AUC(0-24)), area under concentration-time curve from 0 to 
infinity (AUC0-∞), maximum plasma concentration (Cmax), the time to reach 
maximum concentration (tmax), terminal half-life (t1/2), apparent volume of 
distribution (Vd), linear index (LI), and clearance (CL).  
Anti-tumor activity: Complete response (CR), partial response (PR), stable disease 
(SD), progression-free survival (PFS), and duration of response for patients with 
solid tumors. 
Morphologic leukemia-free state in patients with AML. 

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Statistical Method 
It is anticipated that approximately 33 patients will be required to establish the 
RP2D(s) of FN-1501. 
All patients who are exposed to FN-1501 will be included in the safety population. 
All patients who have at least one measurable concentration and for whom valid PK 
parameters can be estimated will be included in the PK population. 
Data will be listed and summarized according to the reporting standards chosen by 
the sponsor. 
 
 
 

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Table of Content 
Synopsis .................................................................................................................................. 12 
List of Abbreviations and Definition ................................................................................... 23 
1.  Introduction .................................................................................................................... 26 
1.1 Background and Pharmacology ..................................................................................... 26 
1.2 Pharmacokinetics ........................................................................................................... 26 
1.3 Toxicology ..................................................................................................................... 28 
1.4 Rationale in Acute Myeloid Leukemia .......................................................................... 28 
1.4.1 Rational for Starting Dose Selection .......................................................................... 29 
2 Study Objectives ................................................................................................................. 30 
2.1 Primary Objectives ........................................................................................................ 30 
2.2 Secondary Objectives .................................................................................................... 30 
3 Study Endpoints ................................................................................................................. 30 
3.1 Primary Endpoints ......................................................................................................... 30 
3.2 Secondary Endpoints ..................................................................................................... 30 
4 Investigational Plan ............................................................................................................ 31 
4.1 Summary of Study Design ............................................................................................. 31 
4.1.1 Dose Escalation ...................................................................................................... 32 
4.1.2 Continuous Treatment ............................................................................................ 35 
4.1.3 Study Procedures .................................................................................................... 35 
4.1.4 Study Stopping Rules ............................................................................................. 41 
4.2 Selection of Study Population ....................................................................................... 41 
4.2.1 Inclusion Criteria .................................................................................................... 41 
4.2.2 Exclusion Criteria ................................................................................................... 42 
4.2.3 Patient Restriction .................................................................................................. 43 
4.2.4 Patient Completion and Discontinuation ................................................................ 43 
5 Study Treatments ............................................................................................................... 44 
5.1 Description of Study Drug ............................................................................................. 44 
5.2 Dosage and Administration ........................................................................................... 44 

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5.2.1 Dose Delays and Modifications .............................................................................. 45 
5.3 Precautions .................................................................................................................... 45 
5.4 Treatment Assignment ................................................................................................... 46 
5.5 Drug Preparation ........................................................................................................... 46 
5.6 Packaging and Labeling ................................................................................................ 46 
5.7 Handling and Storage .................................................................................................... 46 
5.8 Product Accountability .................................................................................................. 46 
5.9 Assessment of Compliance ............................................................................................ 47 
6 Concomitant Medications and Nondrug Therapies ........................................................ 47 
6.1 Permitted Medications ................................................................................................... 47 
6.2 Prohibited Medications .................................................................................................. 47 
6.3 Other Medications to be Used with Caution ................................................................. 49 
7 Safety, Pharmacokinetic, Pharmacodynamic, and Other Assessments ......................... 49 
7.1 Assessments During the Treatment Period .................................................................... 50 
7.1.1 Local Laboratory Evaluation .................................................................................. 50 
7.1.2 Physical Examination and Vital Signs.................................................................... 52 
7.1.3 Electrocardiogram .................................................................................................. 52 
7.1.4 Computed Tomography .......................................................................................... 53 
7.1.5 Adverse Events ....................................................................................................... 53 
7.2 Safety ............................................................................................................................. 53 
7.2.1 Pregnancy ............................................................................................................... 53 
7.3 Safety Follow-up Assessment ....................................................................................... 54 
7.4 Efficacy ......................................................................................................................... 55 
7.5 Pharmacokinetics ........................................................................................................... 55 
7.6 Appropriateness of Measurements ................................................................................ 56 
8 Quality Control and Quality Assurance ........................................................................... 56 
8.1 Monitoring ..................................................................................................................... 57 
8.2 Protocol Amendment and Protocol Deviation ............................................................... 58 
8.3 Data Management/Coding ............................................................................................. 58 
8.4 Quality Assurance Audit ............................................................................................... 59 
9 Adverse Event and Serious Adverse Event ...................................................................... 60 

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9.1 Definition of an Adverse Event ..................................................................................... 60 
9.2 Definition of a Serious Adverse Event .......................................................................... 61 
9.3 Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse 
Events or Serious Adverse Events ....................................................................................... 62 
9.4 Time Period, Frequency, and Method of Detecting Adverse Events and Serious 
Adverse Events .................................................................................................................... 62 
9.5 Recording of Adverse Events and Serious Adverse Events .......................................... 62 
9.6 Evaluating Adverse Events and Serious Adverse Events .............................................. 63 
9.6.1 Assessment of Intensity .......................................................................................... 63 
9.6.2 Assessment of Causality ......................................................................................... 63 
9.7 Follow-Up of Adverse Events and Serious Adverse Events ......................................... 63 
9.8 Prompt Reporting of Serious Adverse Events ............................................................... 64 
9.8.1 Timeframes for Submitting Serious Adverse Events ............................................. 64 
9.8.2 Completion and Transmission of the Serious Adverse Event Report .................... 64 
9.9 Regulatory Reporting Requirements for Serious Adverse Events ................................ 65 
9.10 Post-study Adverse Events and Serious Adverse Events ............................................ 66 
9.11 Serious Adverse Events Related to Study Participation .............................................. 66 
10 Data Analysis and Statistical Considerations ................................................................ 66 
10.1 Sample Size Consideration .......................................................................................... 66 
10.2.1 Analysis Populations ............................................................................................ 66 
10.2.2 Interim Analysis ................................................................................................... 67 
10.2.3 Withdrawal ........................................................................................................... 67 
10.3 Safety Analysis ............................................................................................................ 67 
10.4 Pharmacokinetic Analyses ........................................................................................... 67 
10.5 Efficacy Analyses ........................................................................................................ 68 
11 Ethics ................................................................................................................................. 68 
11.1 Regulatory Authority Approval ................................................................................... 68 
11.2 Ethical Conduct of the Study and Ethics Approval ..................................................... 69 
11.3 Informed Consent ........................................................................................................ 69 
11.4 Investigator Safety Reporting Requirements ............................................................... 69 
12 Study Administration ....................................................................................................... 70 

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12.1 Study and Study Center Closure .................................................................................. 70 
12.2 Records Retention ....................................................................................................... 70 
12.3 Provision of Study Results and Information to Investigators ...................................... 71 
12.4 Information Disclosure and Inventions ....................................................................... 71 
12.4.1 Publication Policy ................................................................................................. 72 
13 References ......................................................................................................................... 73 
14 Appendices ........................................................................................................................ 74 
Appendix 1: SIGNATURE OF INVESTIGATOR ............................................................. 74 
Table of Tables 
Table 1: Suggested Dose Escalation Scheme .......................................................................... 33 
Table 2: Study Assessment and Procedure Schedule .............................................................. 36 
Table 3: Sampling Schedule (Day 1 of Cycle 1 to Day 1 of Cycle 2 Only; Refer to Table 2 for 
complete schedule) .................................................................................................................. 39 
Table 4: Drugs with QTc prolongation potential ..................................................................... 48 
Table 5: Prohibited Medications ............................................................................................. 48 
Table 6: Clinical laboratory assessments ................................................................................ 51 
Table 7: Timeframe for Reporting Serious Adverse Events to the Sponsor ........................... 64 
 
 
 

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List of Abbreviations and Definition 
Abbreviation 
Definition 
AE 
Adverse Event 
ALK 
Anaplastic Lymphoma Kinase 
ALT 
Alanine Aminotransferase 
AML 
Acute Myeloid Leukemia 
ANC 
Absolute Neutrophil Count 
Ara-c 
Cytarabine 
AST 
Aspartate Aminotransferase 
AUC 
Area Under Plasma Concentration-time Curve 
AUC0-24 
AUC from 0 to 24 hours 
AUC0-∞ 
AUC from zero to infinity 
AUC0-last 
AUC from zero to the last measurable concentration 
BMI 
Body Mass Index 
CDK 
Cyclin-dependent Kinase 
CERT 
Center for Education and Research on Therapeutics 
CL 
Clearance  
Cmax 
maximum observed plasma concentration 
CNS 
Central Nervous System 
CR 
Complete Response 
CRO 
Clinical Research Organization 
CT 
Computed Tomography 
CVA 
Cerebral Vascular Accident 
CYP 
Cytochrome P450 
DBP 
Diastolic Blood Pressure 
DDI 
Drug-Drug Interaction 
DLT 
Dose Limiting Toxicity 
ECG 
Electrocardiogram  
ECOG 
Eastern Cooperative Oncology Group  
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
FLT3 
FMS-like tyrosine kinase 3 
GCP 
Good Clinical Practice 
HED 
human equivalent dose 
hERG 
human ether-a-go-go-related 
HSC 
hematopoietic stem cells  
IB 
Investigator’s Brochure  

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Abbreviation 
Definition 
IC50 
50% Inhibition Concentration 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITD 
internal tandem duplication 
JM 
Juxtamembrane Domain 
LI 
Linear Index  
LVEF 
Left Ventricular Ejection Fraction 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic Resonance Imaging 
MTD 
Maximum Tolerated Dose 
NCI-CTCAE 
National Cancer Institute-Common Terminology Criteria for 
Adverse Events 
NYHA 
New York Heart Association 
OS 
Overall Survival 
PD(s) 
Pharmacodynamic(s)  
PDGFR 
Platelet-derived Growth Factor Receptor 
PFS 
Progression-Free Survival 
PK(s) 
Pharmacokinetic(s)  
PR 
Partial Response  
RECIST 
Response Evaluation Criteria in Solid Tumors 
RP2D 
Recommended Phase 2 Dose 
RTK 
Receptor Tyrosine Kinases 
SAE 
Serious Adverse Event  
SBP 
Systolic Blood Pressure 
SD 
Stable Disease 
SMC 
Safety Monitoring Committee  
SOP(s) 
Standard Operating Procedure(s) 
t1/2 
Terminal half-life 
TLS 
Tumor Lysis Syndrome  
tmax 
time to maximum observed plasma concentration 
ULN 
Upper Limit of Normal 
US 
United States 
Vd 
Apparent Volume of Distribution 
Vdss 
Apparent Volume of Distribution at Steady State  
WHO 
World Health Organization 

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Abbreviation 
Definition 
 
 

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1.  Introduction 
1.1 Background and Pharmacology 
Receptor tyrosine kinases (RTK), a group of transmembrane proteins, are 
responsible for growth factor signaling transduction in normal cellular functions. 
Abnormal RTK functions are associated with human tumorigenesis [1]. FMS-like 
tyrosine kinase 3 (FLT3) belongs to the type III receptor tyrosine kinase family 
and plays a well-established role in normal growth and differentiation of 
hematopoietic precursor cells [2]. FLT3 mutations have been reported to occur in 
approximately 30% newly diagnosed acute myeloid leukemia (AML) patients. 
Internal tandem duplications (ITD) in FLT3 is the most frequent mutation in AML 
and correlated with more aggressive progress and poor prognosis [3]. 
FN-1501 is an inhibitor of various tyrosine kinases such as cyclin-dependent 
kinase 4/6 (CDK4/6), platelet-derived growth factor receptor (PDGFR), KIT 
protein, anaplastic lymphoma kinase (ALK) and RET protein, particularly potent 
on FLT3. The preclinical data generated from biochemical, cell based and animal 
in vivo studies suggest that FN-1501 could offer cancer patients clinical benefit by 
inhibiting multiple tyrosine kinases including FLT3, PDGFR, KIT, ALK, RET, 
etc. 
In vivo studies demonstrated that FN-1501 effectively reduced the tumor size of 
MV-4-11 and MOLM-13 (models with FLT3/ITD mutation), as well as inhibited 
the growth of Jurkat and clone E6-1 human leukemia subcutaneous 
xenotransplanted tumor in nude mice in a dose-dependent manner. FN-1501 also 
significantly inhibited the growth of colon cancer cells in animal models. 
FN-1501 levels in plasma and tumor tissue collected from MV-4-11 tumor 
bearing mice after single intravenous injection at the effective dose in an efficacy 
study showed favorable correspondence with the inhibition of STAT5 
phosphorylation, indicating a good pharmacokinetic (PK)/pharmacodynamic (PD) 
efficacy relationship. According to nonclinical PD data in nude mice models 
MV-411 and MOLM-13, the effective dose of FN-1501 in inhibiting 
subcutaneously implanted tumor was 2.5-5 mg/kg, which is equivalent to a human 
dose of 12.5-25 mg. Hence the estimated efficacious dose range in humans is 
between 12.5 and 25 mg/day.  
Please refer to the Investigator’s Brochure (IB) for more detailed information on 
the background of FN-1501. 
1.2 Pharmacokinetics 
FN-1501 showed wide distribution volume and fast plasma clearance (CL) in in 
vivo studies. In plasma protein binding assays using mouse, rat, dog, monkey, and 

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human plasma, FN-1501 exhibited a moderate binding (≥50% and <95.0%) to 
plasma proteins in all 5 species within the range of 0.2 µM to 10 µM. No drug 
accumulation was observed after 7-day consecutive intravenous injection at 
3.64 mg/kg/day in rats or at 0.456 mg/kg in monkeys. 
After single intravenous slow injection at 1.21, 3.64, and 7.28 mg/kg to 
Sprague-Dawley rats, FN-1501 showed the maximum observed plasma 
concentration (Cmax) values of 197 ± 70.7, 580 ± 42.8, and 1510 ± 291 ng/mL, 
respectively, and plasma CL of 117 ± 17.1, 139 ± 19.6, and 98.5 ± 
11.0 mL/min/kg, respectively. Apparent volume of distribution at steady state 
(Vdss) was 22.0±7.51, 21.9±1.84, and 17.8±4.01 L/kg, respectively, and terminal 
half-life (t1/2) was 2.82 ± 0.749, 2.51 ± 0.0817, and 3.01 ± 0.469 hours, 
respectively. Following single intravenous slow injection administration of 
FN-1501 at 0.152, 0.456, and 0.912 mg/kg in cynomolgus monkeys, Cmax 
appeared immediately after infusion. The Cmax values were 263±62.2, 780±51.4, 
and 1480±164 ng/mL, respectively; CL was 42.3±5.40, 34.8±5.68, and 
28.4±4.04 mL/min/kg, respectively; the Vdss was 5.88±1.20, 8.58±1.60, and 
9.18±1.91 L/kg, respectively; t1/2 was 2.40±0.286, 4.56±1.88, and 6.77±1.96 h, 
respectively. 
After single intravenous slow injection at 3.64 mg/kg to Sprague-Dawley rats, 
FN-1501 distributed to all tissues within 15 minutes. The highest tissue exposure 
area under plasma concentration-time curve (AUC)0-last was observed in spleen. 
A total of 8 drug metabolites were identified in liver microsomes of mouse, rat, 
dog, monkey, and humans after incubation with FN-1501 at 37°C for 60 minutes. 
The four metabolites detected in human liver microsomes were all found in 
monkey liver microsomes, suggesting that no unique metabolites were formed in 
human liver microsomes. Among the four metabolites detected in human liver 
microsomes, three (M4, M5, M7) were in low level while M3 was 16.89% of total 
drug. FN-1501 was mainly metabolized via oxidation and N-demethylation. 
cytochrome P450 (CYP)3A was the major metabolic enzyme; other CYP 
isozymes played minor or no role in the metabolism of FN-1501. 
FN-1501 was mainly excreted through feces and urine. Following single 
intravenous slow injection of FN-1501 at 3.64 mg/kg to male and female 
Sprague-Dawley rats, the gender averaged drug recovery of FN-1501 from feces 
and urine at 120 hours post dose was 54.4 ± 9.55% of nominal dose, and feces 
was the main excretion pathway. The gender averaged drug recovery of FN-1501 
from bile at 72 hours post dose was 18.2 ± 5.55% of nominal dose. 
Please refer to the IB for more detailed information on the PK of FN-1501 [4]. 

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1.3 Toxicology 
The non-clinical toxicity profile of FN-1501 was characterized in both rats and 
monkeys in single and repeat dose studies up to 28 days, and in a core battery of 
genotoxicity tests, including in vitro Ames and chromosomal aberration assays, 
and an in vivo bone marrow micronucleus assay in mice.  
FN-1501 related pathological changes in rats include weakness, eye discharge, 
squint, reduced spontaneous motor activities, reduced body weight and body 
weight gain, lacrimation, sparse hair, macropathological ulcer and swelling on 
skin, decreased blood cell count and histological ulcer and swelling of 
dermatitis. Possible test article-related pathological changes were osteosclerosis 
in bone marrow (femur and sternum), basophilic tubule in kidney, and atrophy in 
thymus. The maximum tolerated dose (MTD) was 15 mg/kg in a repeated-dose 
toxicity study and the lethal dose was 40 mg/kg in an acute toxicity study in rats. 
FN-1501 related pathological changes in monkeys included erythema and 
edema at injection sites, foot ulcer, and decreased blood cell count. Possible 
test article-related pathological changes were small thymus, thymus atrophy, 
and necrosis. The MTD of FN-1501 in monkeys was 10 mg/kg in an acute 
toxicity study and 2 mg/kg in a 28-day repeated-dose study. 
The study on human ether-a-go-go-related (hERG) current showed that FN-1501 
inhibited hERG current of HEK-293 cells, wherein 50% inhibition concentration 
(IC50) was 2.870 μM. 
FN-1501 transiently and mildly elevated diastolic blood pressure (DBP) and mean 
arterial blood pressure at the dosage of 2 and 4 mg/kg and decreased body 
temperature at the dosage of 4 mg/kg. There were no effects on electrocardiogram 
(ECG) parameters at any dose level in this study. 
No mutagenicity or genotoxicity was detected in the absence and presence of a 
metabolic activation system. 
Refer to the IB for more detailed information on the toxicity of FN-1501 [4]. 
1.4 Rationale in Acute Myeloid Leukemia 
AML accounts for about 80% of adult acute leukemia cases, with an incidence of 3-
5/100,000 in the United States (US). The incidence of AML increases with age. For 
example, the incidence of AML increases from 1.3/100,000 in those under 65 to 
12.2/100,000 in those 65 and above. The "3+7" induction chemotherapy, i.e., 1-2 
cycles of the standard-dose of cytarabine (Ara-c) in combination with anthracyclines 
(rubidomycin, daunorubicin, etc.) is the recommended first line treatment for AML, 
which exhibits a complete remission rate of higher than 80%, then followed by the 

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consolidation chemotherapy (1-3 cycles of Ara-c). The 5-year overall survival (OS) 
can reach 40-50% with this regimen. However, after being treated with the “3+7” 
treatment scheme for 1-2 cycles, 10% to 40% of patients with AML fail to achieve 
complete response (CR) or relapse within six months after the first CR. No drug has 
yet been approved by the Food and Drug Administration (FDA) in treatment of 
recurrent/refractory AML and clinical trials are strongly recommended. Currently, the 
only treatment option is incremental dose of Ara-c or combination of multiple drugs, 
which bear non-significant efficacy in terms of remission rate and long-term OS 
benefit.   
AML is caused by abnormal proliferation and differentiation of hematopoietic stem 
cells (HSC), characterized by clinical manifestations and significant biological 
heterogeneity. Nearly all (97%) of AML patients present molecular abnormality to a 
certain degree, FLT3 mutations are found in 30% of them [5]. FLT3 belongs to the 
Type III RTK family. FLT3 consists of four domains: 1) extracellular N-terminus 
including 5 immunoglobulin-like domains, is a ligand-binding site; 2) transmembrane 
domain; 3) intracellular juxtamembrane domain (JM) and 4) intracellular C--terminal 
kinase domain. When ligands bind to extracellular region, FLT3 receptors are 
dimerized, terminal kinase domain is activated to release the intracellular signaling 
molecules, and the growth and development of HSC are regulated through PI3K/AKT 
and MAPK signaling pathways. FLT3/ITD mutation is the most common FLT3 
mutation, which accounts for about 20% of all FLT3 mutations. ITD mutation leads to 
non-ligand-dependent dimerization of FLT3, continuously activates intracellular 
signaling pathways, realizes non-cytokines-dependent cell proliferation and 
differentiation disorders thus results in leukemia. FLT3 point mutation can be found 
in 7%-10% AML patients, and its correlation with AML is not fully understood. At 
present, development of FLT3-ITD-targeted therapeutics is very active and FDA 
granted Breakthrough Therapy designation to Midostaurin in February 2016 and 
Priority Review status was granted in November 2016. In 2017, Midostaurin became 
the first potential AML targeted therapy approved by FDA. In their pivotal trial, 
midostaurin plus standard chemotherapy was superior to placebo plus standard 
chemotherapy in OS (HR 0.77; 95% CI 0.63, 0.95; 2 sided p = 0.016) [6].   
FN-1501, a new investigational inhibitor of FLT3, may provide clinical benefit for 
patients in the treatment of relapsed or refractory AML with or without the presence 
of the FLT3 mutation. 
1.4.1 Rational for Starting Dose Selection 
A dose of 2.5 mg/day is selected as the starting dose in this study based on the 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use (ICH) S9 [7] and results of toxicological studies. 
ICH S9 recommends that the starting dose should be 1/6th of MTD observed in non-

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rodent studies. The MTD is calculated as 2 mg/kg from the 28-day repeated 
intravenous infusion toxicity study in monkeys. Using the conversion factors 
published in the FDA Guidance for Industry, Estimating the Maximum Safe Starting 
Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (2005) 
[8], the human equivalent dose (HED) derived from 1/6th of the monkey MTD is 
6.48 mg/d. However, considering FN-1501 as a novel API with limited toxicity data, 
we set the lower starting dose at 1/10th of MTD calculated from the 28-days repeated 
toxicity study in monkeys, which is 3.88 mg/d. Because the strength of FN-1501 is 
10 mg/vial and 3.88 mg/d is not convenient in clinical practice, we finally choose 
2.5 mg (1/4 × 10 mg) as the safe starting dose for the First-in-Human clinical trial. 
2 Study Objectives 
2.1 Primary Objectives 
To evaluate the safety and tolerability of FN-1501 
To determine the MTD and recommended phase 2 dose (RP2D) 
2.2 Secondary Objectives 
To characterize the PK of FN-1501 and major metabolites 
To describe the preliminary anti-tumor activity of FN-1501 
3 Study Endpoints 
3.1 Primary Endpoints 
The safety of FN-1501 will be assessed throughout the study by monitoring adverse 
events (AEs) and serious adverse events (SAEs) [per the National Cancer Institute-
Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.3], 
physical examination, and laboratory measurements.  
The MTD of FN-1501 will be the highest dose under which one or no case of dose 
limiting toxicity (DLT) is observed while the RP2D of FN-1501 will be determined 
based on PKs, safety and tolerability, as well as preliminary efficacy. 
3.2 Secondary Endpoints 
Blood sample collection: 
Cycle 1 Day 1: pre-dose, post dose 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, and 
48 hours and on Day 8 prior to that days dose (if applicable) 
PK for single dose profile: 

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AUC from zero to the last measurable concentration (AUC0-last), AUC from 0 to 
24 hours (AUC0-24) , AUC from zero to infinity (AUC0-∞), Cmax, time to maximum 
observed plasma concentration (tmax), t1/2, CL, apparent volume of distribution (Vd), 
and Linear Index (LI).  
Endpoints for anti-tumor activity evaluation 
Anti-tumor activity will be evaluated by investigators according to Response 
Evaluation Criteria in Solid Tumors (RECIST) v1.1 (solid tumor), performance status, 
and Computed Tomography (CT)/ Magnetic Resonance Imaging (MRI) image at 
designated time point and time of event. Imaging for disease assessment will be 
performed every 6 weeks to summarize CR, partial response (PR), stable disease 
(SD), progression-free survival (PFS), and duration of response for patients with solid 
tumors. 
In patients with AML, response will be evaluated according to the AML response 
criteria [5]. Bone marrow assessments will be performed at Screening, the end of 
every other cycle, and at the end of the study or at time of relapse. 
Based on the patient’s clinical condition, complete blood counts or bone marrow 
assessments may occur more frequently based on Investigator’s judgment. 
4 Investigational Plan 
4.1 Summary of Study Design 
This is a phase 1, first-in-human, open-label, multi-center, single-arm, dose escalation 
clinical study in patients with histologically or cytologically confirmed advanced solid 
tumors or relapsed/refractory AML, who cannot tolerate or do not respond to standard 
systemic therapy. 
Patients will be screened for eligibility for up to 21 days prior to entry into the study. 
The starting dose will be 2.5 mg/day on the assigned days. Dose escalation will use 
the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is 
reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 
30 mg/day. Eligible patients will receive a single intravenous infusion of study drug 
on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle.  
The DLT assessment period is 21 days from the first dose of FN-1501. Evaluation of 
a cohort of at least three (3) patients completing DLT assessment at any given dose 
level is required prior to determining the next dose level and dose regimen for the 
subsequent cohort. 

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The highest dose under which one or no case of DLT is observed will be considered 
as MTD. If DLT cannot be observed, RP2D will be determined based on safety, 
preliminary anti-tumor activities and PK data.  
Approximately thirty-three patients are expected to be enrolled. 
After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent 
patients in that cohort will not be dosed until the first patient has been evaluated for at 
least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation 
will be performed by investigators, the medical monitor, and the sponsor. A Safety 
Monitoring Committee (SMC) will determine dose levels to be administered and dose 
regimen during dose escalation based on the data available from the previous dose 
levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be 
determined based on PKs, safety, tolerability, and preliminary efficacy. 
If a patient wishes to continuously receive study treatment on completion of Cycle 1, 
the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles 
(same as Cycle 2, all of 21 days’ duration), defined as administration of 3 times per 
week for 2 weeks followed by 1 week rest, at the discretion of the investigator. 
4.1.1 Dose Escalation 
The DLT assessment period is 21 days starting from the first dose of FN-1501. The 
study will follow a standard 3+3 dose escalation scheme and a modified Fibonacci 
sequence until the MTD is reached. Increments of 33% in the dose of FN-1501 will be 
undertaken after reaching 30 mg/day. Because of the dosage form (10 mg/vial), each 
dose will be rounded to numbers such as 2.5, 5, 10, 15, 22.5 mg/day, etc. At least 
three (3) patients will be enrolled into each cohort.  
Additional patient(s), up to a maximum of four (4) patients in total, may be enrolled 
in a cohort if more than three (3) have been screened and are eligible for the cohort.  
The DLT assessment and dose-escalation scheme will follow the same principle as 
stipulated for a standard 3+3 dose escalation design. For example, one (1) to three (3) 
additional patients will be enrolled if a DLT is observed in one (1) of first three (3) 
patients. No additional patients are required if a DLT is observed in one (1) of six (6) 
patients.  
The starting dose will be 2.5 mg/day administered on the assigned days. One possible 
dose escalation scheme is presented in Table 1. Other dose levels may be evaluated 
during the study, depending on emerging data.  

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Table 1: Suggested Dose Escalation Scheme 
Dose Level/Cohort 
Dose (mg/d) 
Increase (%) 
1 
2.5 
100 
2 
5 
100 
3 
10 
50 
4 
15 
50 
5 
22.5 
33 
6 
30* 
33 
7 
40* 
33 
The actual dose levels and dose regimens administered in each step will depend on the data 
available from the previous level, as determined by the Safety Monitoring Committee.   
* Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day 
until the MTD is reached. 
As currently planned, if none (0) of the patients in one cohort experience DLT during 
the DLT assessment period, the dose to be administered in the next cohort will be 
increased by up to 100% (up to the 10 mg/d dose), by up to 50% (for the 10 mg and 
22.5 mg doses) and by 33% thereafter, as determined by the SMC formed by the 
medical monitor, investigator, and sponsor representative.  
The dose intervals will follow standard 3+3 escalation rules starting with the 
treatment of 3 patients as follows: 
1. If 0 of 3 patients experiences a DLT, dose escalation will proceed to the 
next higher dose level at which 3 patients (up to 4) will be enrolled. 
2. If 1 of 3 patients experiences a DLT, 3 more patients will be enrolled at the 
same dose level. 
3. Escalation will continue if 0 or 1 of 6 patients experiences a DLT. 
4. If 2 or more patients in any dose level experience a DLT, dosing will stop. 
No additional patients will be treated at a given dose level if two (2) or more of 
the patients in the cohort develop a DLT during the DLT assessment period. In 
this instance, the MTD is considered to have been exceeded. If the MTD is 
exceeded, the next lower dose level is considered MTD. Depending on the 
decision of the SMC and on review of available data, an additional intermediate 

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dose level, between the MTD-exceeding dose level and the next lower dose 
level, may be explored. If an MTD is not identified due to paucity of DLTs, the 
RP2D will be determined based on PKs, safety, tolerability, and preliminary 
efficacy. 
DLT Definition: 
DLT is any AE not attributable to disease or disease-related processes that occur 
during the DLT assessment period. DLT is determined by investigators based on 
NCI-CTCAE Version 4.03: 
Non-hematologic: 
• Grade 3 or greater nausea, vomiting and diarrhea despite optimal 
supportive care 
• Any other clinically relevant ≥ Grade 3 non-hematologic toxicity 
(excluding asymptomatic biochemical abnormalities that are not 
clinically significant and resolve to Grade 2 or less in <7 days) 
• Persistent Grade 2 toxicity such as nausea, vomiting, or fatigue despite 
optimal standard medical therapy that, in the opinion of the investigator, 
prevents continuous dosing 
• Any toxicity which in the judgment of the investigator or sponsor is 
dose limiting 
Hematologic: 
• Grade 4 neutropenia lasting > 7 days 
• Grade 3 Febrile neutropenia (defined as absolute neutrophil count 
[ANC] < 1000/mm3 with a single temperature of 38.3oC or a sustained 
temperature of 38oC for > 1 hour) 
• Grade 3 neutropenic infection 
• Grade 3 thrombocytopenia with bleeding 
• Grade 4 thrombocytopenia 
For elevations in hepatic function enzymes, DLT is defined as follows: 
• Grade 4 aspartate aminotransferase (AST) or alanine aminotransferase 
(ALT) increase 
• AST or ALT > 5 × upper limit of normal (ULN) if accompanied by 
≥ Grade 2 elevation in bilirubin 
• AST or ALT > 5 × ULN lasting > 3 days in patients without liver 
metastases 

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• AST or ALT > 5 × ULN lasting > 3 days if the baseline value was ≤ 3 
× ULN in patients with liver metastases 
• AST or ALT > 8 × ULN lasting > 3 days if the baseline value was > 3 
× ULN but ≤ 5 × ULN in patients with liver metastases 
 
Specific DLT definitions for patients with AML: 
Non-hematologic:  
• All non-hematologic toxicities NCI-CTCAE ≥ Grade 3 
Hematologic:  
• Prolonged myelosuppression defined as persistence of ≥ Grade 4 
neutropenia or thrombocytopenia in the absence of leukemia (blast count 
<5%) at least 42 days after the initiation of Cycle 1 
4.1.2 Continuous Treatment 
At the discretion of the investigator, patients may receive continuous treatment, at the 
same dose, upon completion of the DLT assessment period until disease progression, 
intolerable toxicity, withdrawal of consent, or termination according to the Principal 
Investigator’s judgment or at the sponsor’s request. Continuous treatment is defined 
as administration 3 times per week for 2 weeks followed by 1-week rest in a repeating 
21-day cycle.  
4.1.3 Study Procedures 
Study procedures are listed and described in Table 2. Detailed descriptions of the time 
points for PK sampling, ECG, and vital signs evaluations in the first week of Cycle 1 
is included in Table 3.

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Table 2: Study Assessment and Procedure Schedule 
Assessment  
Screen 
period  
Cycle 1 (21 days) 
Subsequent 
cycles (21 days) 
Follow-up/ 
End of Study 
Day of Cycle  
-21 to 
-1 
11 
2 
3 
5 
8 
10 
12 
12 
(±3) 
8 
(±3) 
30 to 35 days 
post last 
dose 
Inform consent 
X 
 
 
 
 
 
 
 
 
 
 
Review 
eligibility  
X 
 
 
 
 
 
 
 
 
 
 
Demographic 
data 
X 
 
 
 
 
 
 
 
 
 
 
Medical 
history/ 
baseline 
conditions 
X 
 
 
 
 
 
 
 
 
 
 
Disease 
assessment 
Solid Tumors3 
X 
Every 6 weeks ± 5 days and as detailed in the footnote 
Disease 
Assessment 
AML3 
X 
Every 6 weeks ± 5 days and as detailed in the footnote 
Vital signs 
X 
X4 
X 
X4 
X4
X4 
X4 
X4 
X4 
X4 
X 
Weight  
X 
X4 
X 
X4 
X4
X4 
X4 
X4 
X4 
X4 
X 
Physical exam5 
X 
X4 
X 
X4 
X4
X4 
X4 
X4 
X4 
X4 
X 
ECOG 
performance 
review 
X 
X4 
 
 
 
X4 
 
 
X4 
 
X 
12-lead ECG6 
X 
X 
 
 
 
 
 
 
X 
 
X 
Concomitant 
medications 
review 
X 
X 
 
 
 
X 
 
 
X 
 
X 
CT or MRI 
(solid tumor 
only) 
X7 
Every 6 weeks ± 5 days 
Pregnancy test8 
X 
X 
 
 
 
 
 
 
X 
 
 
Hematology9  
X 
X4 
 
 
 
X4 
 
 
X4 
X4 
X 
Blood 
chemistry + 
amylase and 
lipase tests9 
X 
X4 
 
 
 
X4 
 
 
X4 
X4 
X 

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Assessment  
Screen 
period  
Cycle 1 (21 days) 
Subsequent 
cycles (21 days) 
Follow-up/ 
End of Study 
Day of Cycle  
-21 to 
-1 
11 
2 
3 
5 
8 
10 
12 
12 
(±3) 
8 
(±3) 
30 to 35 days 
post last 
dose 
Bone Marrow 
Biopsy for 
patients with 
AML10 
X 
Every 6 weeks ± 5 days and as detailed in the footnote 
Coagulation 
test9 
X 
 
 
 
 
 
 
 
 
 
X 
Urinalysis11  
X 
 
 
 
 
 
 
 
X 
 
X 
Adverse event 
X 
X continuous 
PK blood 
sample 
 
X 
X 
X12 
 
 
 
 
 
X12 
 
 
Study drug13 
administration 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Abbreviations: AML = Acute Myeloid Leukemia; BMI = Body Mass Index; CT = computed 
tomography; ECOG = Eastern Cooperative Oncology Group; MRI = magnetic resonance 
imaging; PK = pharmacokinetic  
1. 
On Day 1 of Cycle 1, patients may need to stay at the clinical research unit overnight to 
complete PK sampling, safety observation and assessments. 
2. 
For DLT cycle, patients will return for the end of the DLT assessment period (21 days 
from first dose of FN-1501) assessments on Day 1 of Cycle 2 (±3 days). If additional cycles 
are planned, patients will start Day 1 dosing of next cycle after the assessments. For the last 
cycle, patients will return for the assessments. 
3. 
Disease assessment every 6 weeks to coincide with every other cycle. Refer to 
Section 7.4 for details.   
4. 
These assessments should be conducted, and the results should be available before study 
drug administration in each cycle. If assessments are conducted within 3 days prior to Day 1 
of the cycle, the data can be recorded as Day 1 data of the cycle. See Table 3 for details. 
Height to be measured at Screening for BMI calculation. 
5. 
A full physical exam will be conducted at screening, on Day 1 of each cycle and at 
follow-up. A full physical exam includes assessments of cardiovascular, respiratory, 
abdominal and neurological systems as well as lymph nodes/spleen, skin, oropharynx and 
extremities. Refer to Section 7.1.2 for details.  

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6. 
ECGs to be performed prior to that days dose (if applicable) and after the patient has 
been supine for at least 10 minutes and should be performed with the patient in the same 
physical position for the duration of the test. ECG at Screening: performed in triplicate (5-10 
min between readings). ECG at Day 1 of Cycle 1: performed in triplicate (5-10 min between 
readings) at the days indicated in Table 2 and time points and time windows detailed in  
Table 3. Cycle 2 Day 1: Perform in triplicate (5-10 min between readings) only if patient has 
a significant QTc prolongation, that is, a) > 500 msec; or b) increased by ≥ 60 msec over 
baseline; and/or c) decreased by 50 msec below pre-dose recording. If prolongation of QT or 
QT interval corrected for heart rate (QTc) is noted during the first 2 weeks, triplicate 12 lead 
ECGs will be conducted weekly during Cycle 2, and then once every 3 weeks before 
administration and 5-15 minutes after administration on Day 1 of every cycle from Cycle 3 
onwards, until discontinuation of FN-1501 treatment. Refer to Section 7.1.3 for details on 
significant QTc prolongation.  
7. 
Data obtained up to 42 days prior to Day 1 is acceptable. 
8. 
Only in women of childbearing potential and additionally at the investigator’s discretion. 
9. 
In the event of neutropenia, thrombocytopenia, or ≥ Grade 3 clinical chemistry toxicity, 
these assessments will be conducted as frequent as the investigator feels necessary until 
toxicity is resolved (≤ Grade 2). Refer to Table 6 for details on laboratory assessments.  
10. Bone marrow biopsy for related assessments will be performed in patients with AML at 
Screening, every 6 weeks to coincide with the end of every other cycle, and at the end of the 
study or at time of relapse. Based on the patient’s clinical condition, complete blood counts or 
bone marrow assessments may occur more frequently based on Investigator’s judgment. 
11. If urine protein is ≥ 2+ by dipstick, then 24-hour urine for total protein and a random 
urine for total protein and creatinine will be collected and evaluated. See Section 7.1.1 for 
details. 
12. Refer to Table 3 for details. PK sample must be collected pre-dose on Day 3 of Cycle 1 
and pre-dose on Day 1 of Cycle 2 and as detailed in Table 3. 
13. The investigational drug should be administered at approximately same time each time. 
The investigational drug is administered on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. 
Not all treatment administration days are illustrated in the table.  
 
 
 
 
 

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Table 3: Sampling Schedule (Day 1 of Cycle 1 to Day 1 of Cycle 2 Only; Refer to Table 2 for complete schedule) 
Cycle 
Cycle 1 
Cycle 2 
Day of cycle 
Day 1 
Day 2 
Day 3 
Day 1 
 
 
Post-Day 1 Dose Time Point: 
 
Time 
point1  
Pre-
dose 
5 min 
15 min 
30 min 
1 hr 
2 hr 
4 hr 
6 hr 
8 hr 
12 hr
24 hr 
48 hr  
(pre-Day 3 dose)
Pre-dose  
 
PK sample 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X1 
X1 
ECG2 
X 
 
 
 
X 
X 
 
 
 
 
 
 
X 
Vital signs2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
1. Abbreviations: ECG = electrocardiogram; hr = hour; min = minute; PK = Pharmacokinetic Time point relative to end of infusion on Cycle 1, Day 1. Blood 
sample will be collected pre-dose on Day 3 of Cycle 1 and Day 1 of Cycle 2. See next page for sampling time windows.  
2. Vital signs and ECG also collected at follow-up not shown (see Table 2 for details). Vital signs and ECG are predose unless otherwise indicated. 
 

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Sampling Time Windows 
The following time windows (relative to end of infusion) are allowed for PK sampling, ECG, and vital signs, as applicable:  
 For pre-dose time points (Days 1, 3, and Cycle 2, Day 1): within 1 hr before dosing the planned study drug administration  
 For 24 hr and 48 hr time points: +/- 1 hr., (prior to dosing on Day 3)  
 For 2, 4, 6, 8 and 12 hr time points: +/- 30 min.  
 For 30 min, 1 hr time points: +/- 15 min.  
 For 15 min time point: +/- 5 min.  
 For 5 min time point: +/- 3 min.  
The actual time of PK sampling should always be recorded and entered in CRF.  

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4.1.4 Study Stopping Rules 
The estimated duration of the study is contingent on the number of dose levels 
evaluated in the dose escalation. The study will be discontinued in the event of any 
new findings that indicate a relevant deterioration of the risk-benefit relationship that 
would render continuation of the study unjustifiable, or for administrative reasons by 
the Sponsor.  
4.2 Selection of Study Population 
4.2.1 Inclusion Criteria 
Each patient must meet all the inclusion criteria for this study at the time of starting 
study treatment: 
1. Male and female 18 years old and above 
2. Able to understand and sign informed consent form 
3. Patients with histologically or cytologically confirmed advanced solid tumors 
who have relapsed or refractory disease or relapsed/refractory AML for which no 
standard therapies expected to produce clinical benefit to the patient are available 
4. Patients with diagnosed solid tumors must have at least one lesion that is 
measurable per RECIST v1.1 criteria  
5. Patients with relapsed or refractory AML must be diagnosed with AML based on 
World Health Organization (WHO) criteria (≥ 20% blasts in bone marrow) 
Patients with acute promyelocytic leukemia are excluded.  
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 
7. Have discontinued all previous cancer therapies for at least 21 days (for solid 
tumors) or at least 7 days (for AML) or 5 half-lives prior to study treatment, 
whichever is shorter, and recovered from the acute adverse effects of therapy 
8. Expected to survive at least 2 to 3 months 
9. Left ventricular ejection fraction (LVEF) ≥ 50% and QTc interval < 450 ms 
10. Women shall meet either of the following conditions before enrollment 
- 
Infertile, defined as having a bilateral oophorectomy (ovariectomy), or a 
bilateral tubal ligation, or being post-menopausal for at least 1 year 
- 
For those of childbearing potential, they should have a negative serum 
pregnancy test during screening, agree to refrain from lactation, and use 
effective contraception such as hormonal methods associated with inhibition 
of ovulation, condom, intra-uterine device, surgical sterilization (including 
partner’s vasectomy) or sexual abstinence during the study and 30 days after 
the last administration of study drug 
11. Men who are engaging or plan to engage in sexual activity with a female of 
childbearing potential must either have a prior vasectomy or agree to use 
effective contraception such as condoms, sexual abstinence and appropriate 
methods taken by their partner(s) during the study and 90 days after the last dose 

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12. Patients must have adequate organ functions as indicated by the following 
screening laboratory values: 
- Serum total bilirubin ≤ 1.5 × ULN (Serum total bilirubin can be ≤ 3.0 × ULN 
if patients have hemolysis or congenital hemolytic diseases) 
- Creatinine < 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min 
- AST and ALT ≤ 2.5 × ULN (AST and ALT can be ≤ 5 × ULN for patient 
with liver metastases) 
- ANC ≥ 1.5 × 109/L 
- Platelets ≥ 100 × 109/L 
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (Note: Criteria must be met without a 
transfusion within 2 weeks of obtaining the sample)  
Note:  Laboratory requirements for complete blood counts (hemoglobin, 
ANC, and platelets) do not apply to AML patients 
4.2.2 Exclusion Criteria 
Patients who meet any of the following exclusion criteria are not eligible to 
participate in this study: 
1. Participation in another therapeutic clinical trial within 3 weeks of enrollment 
2. A previous toxicity-related reaction to cancer therapy and have not recovered 
within 2 weeks of enrollment (>Grade 2 NCI-CTCAE Version 4.03) 
3. Having received a major surgical operation within 4 weeks of enrollment or not 
completely recovered from a previous operation  
4. Any serious or uncontrollable systemic disease, including but not limited to: 
Hypertension (after treatment, systolic blood pressure (SBP) > 180 mmHg and/or 
DBP > 100 mmHg) and active hemorrhagic disorders; patients who are 
determined by investigators as otherwise not suitable for participation in this 
study. Note: Patients that in the judgment of the investigator have clinical signs of 
disease progression during the screening period (i.e.: febrile neutropenia, ascites 
requiring drainage, hospitalization due to worsening underlying disease, etc.) will 
not be eligible for participation. 
5. Active known infection, including hepatitis B, hepatitis C, and human 
immunodeficiency virus 
6. Primary central nervous system (CNS) tumor or CNS metastases, as indicated by 
clinical symptoms, cerebral edema, and/or progressive growth (patients with a 
history of CNS metastases or cord compression are allowable if they have been 
definitively treated and have been clinically stable for at least 3 months, and off 
steroids or anticonvulsants ≥ 2 weeks before first dose of study drug) 
7. Serious kidney injury, requiring dialysis 
8. Serious liver injury, and advanced liver diseases of Child-Pugh class B and C 

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9. On medications that are strong CYP3A inhibitors or inducers unless patients are 
willing and able to change to use of an equivalent medication that is not a strong 
CYP3A inhibitor or inducer 
10. Cardiac function and disease history which meets one or more of the following 
conditions: 
- Any risk which may increase QTc interval prolongation, such as hypokalemia, 
hereditary long QT syndrome, and taking drugs that can prolong QT interval 
- Acute myocardial infarction ≤ 6 months prior to Day 1 
- Clinically significant arrhythmia ≤ 6 months prior to Day 1 
- Congestive heart failure ≥ Grade 3 by New York Heart Association (NYHA) 
≤ 6 months prior to Day 1 
- Cerebral vascular accident (CVA) ≤ 6 months prior to Day 1 
11. Are pregnant or breastfeeding 
4.2.3 Patient Restriction 
Patients should avoid grapefruit and products containing grapefruit. 
4.2.4 Patient Completion and Discontinuation 
4.2.4.1 Patient Completion 
A patient will be considered complete if he/she has a valid PK profile and has not 
withdrawn from the study prior to completing the DLT assessment period (21 days 
from first dose of FN-1501). 
4.2.4.2 Patient Discontinuation 
A patient must be discontinued if any one or more of the conditions occur: 1) DLT 
occurs and the toxicity has not improved to Grade 1, Grade 0 or baseline within 14 
days of onset; 2) occurrence of other toxicities that makes continuation of study 
treatment intolerable; 3) a third dose-reduction is required; 4) treatment delay is more 
than 4 weeks, unless resuming treatment is regarded beneficial to the patient by the 
investigator and agreed by Sponsor’s medical monitor; 5) in the opinion of the 
investigator, continuous treatment is not beneficial to the patient. 
A patient may voluntarily discontinue participation from this study at any time. If a 
patient is discontinued from participation in the study for any reason, the investigator 
must make every effort to perform the following evaluations 30 to 35 days from the 
last dose of FN-1501: physical examination, vital signs, ECG, laboratory tests 
(hematology, chemistry, coagulation, and urinalysis), and AE assessment. These data 
will be recorded as they comprise an essential evaluation that should be done prior to 

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discharging any patient from the study. If a patient is discontinued from the study at 
any time due to an AE (as defined in Section 9.1), the procedures stated in Section 9.7 
must be followed.  
The reason for discontinuation will be recorded in the electronic case report form 
(eCRF). These reasons may include: 
 Withdrawal of consent by the patient 
 Discontinuation of FN-1501 by the sponsor 
 Pregnancy 
 Any significant AE that compromises the patient’s ability to participate in 
the study 
 The investigator or sponsor determines it is in the best interest of the 
patient 
 Progression of disease at any time during the study 
 Need for prohibited medication 
 Lack of compliance with the study and/or study procedures (e.g., 
administration instructions, study visits) 
 Significant deviation from the protocol without the consent of the sponsor 
Premature discontinuation of FN-1501 occurs when a patient is discontinued for 
reasons other than unacceptable toxicity during DLT evaluation cycle. Prematurely 
discontinued patients will be considered for replacement after due consideration from 
sponsor and SMC. 
5 Study Treatments 
5.1 Description of Study Drug 
The product is a white to off-white sparse cake or powder contained in vials. Each 
vial contains 10 mg FN-1501. It will be reconstructed with 5% glucose prior to use. 
5.2 Dosage and Administration 
Patients will receive intravenous infusion of FN-1501 on the assigned days starting 
with the 2.5 mg/day cohort. FN-1501 will be diluted in 10 mL of 5% glucose solution 
and added in 100 mL 5% glucose for intravenous infusion over 1 hour. For 
procedures for dose escalation, refer to Section 4.1.1. 

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5.2.1 Dose Delays and Modifications 
Interruption/reduction of dosing for AEs may take place any time during the study. 
Below are general guidelines for dose delays and modifications for FN-1501 related 
toxicities. 
Dose Delays 
Treatment with FN-1501 should be withheld from a patient who experiences an AE of 
Grade 3 or higher until the toxicity resolves to Grade 1, Grade 0 or baseline. Dosing 
with FN-1501 may be resumed following resolution of toxicity at the next lower dose 
level. The resumed dosing will be given at the next regularly scheduled time point. If 
the AE is clearly not associated with the study treatment, the dosing may be resumed 
at the original dose level, after discussion with the sponsor’s medical monitor. 
If a patient requires a treatment interruption of more than 4 weeks for any reason, the 
patient should be withdrawn from the study treatment, unless resuming the treatment 
is regarded beneficial to the patient by the investigator and agreed upon by the 
sponsor’s medical monitor.  
Dose Modifications 
Dose reductions are allowed if patients resume study treatment after dose interruption 
for toxicity. A maximum of two dose reductions are permitted. If further dose 
reduction is needed, the patient should be withdrawn from study treatment. 
A patient may switch to a higher dose at the discretion of the investigator, if 1) the 
safety of the higher dose level has been fully evaluated and determined not to exceed 
MTD; and 2) the patient has been treated at the current dose level for at least 2 cycles 
without experiencing a clinically significant treatment-emergent AE. However, if 
Grade 3 or higher toxicity occurs or continues after permitted dose increase or 
reduction, then the patient should be withdrawn from study treatment. 
Any resumed or modified dose will start as a new cycle. 
5.3 Precautions 
Tumor Lysis Syndrome (TLS) has been reported as a potential risk in patients with 
AML, including those patients that have predisposing factors such as elevated lactate 
dehydrogenase, leukocytosis, tumor burden, hydration status and/or renal dysfunction.  
Patients at risk of developing TLS or patients that develop TLS should be treated with 
prophylaxis and therapeutic measures respectively as per Institutional Guidelines.  

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5.4 Treatment Assignment 
Patients will be identified by a subject number. Each patient enrolled in this study will 
receive a unique subject number, which will be assigned when the patient is screened 
or enrolled in the study. Each patient receiving FN-1501 will also receive a treatment 
allocation number. Subject numbers and treatment numbers will be assigned in 
chronological order starting with the lowest number. Once a subject number and 
treatment number have been assigned to a patient, it cannot be reassigned to another 
patient. 
A patient who withdraws from the study for reasons other than DLT may be replaced. 
If a patient is replaced, the replacement patient will be assigned the next available 
subject number and treatment number. 
5.5 Drug Preparation 
Specific instructions for acquisition, storage and preparation of FN-1501 and 
preparation of final dosing solution will be provided in the Pharmacy binder provided 
to the sites.  
5.6 Packaging and Labeling 
The drug product is packed in 10 mL, type I glass vials. The vial is sealed with a 
bromobutyl stopper covered by an aluminum flip-off cap. 
The contents of the label will be in accordance with all applicable regulatory 
requirements. 
5.7 Handling and Storage 
The study drug will be dispatched to a study center only after receipt of the required 
documents in accordance with applicable regulatory requirements and the sponsor’s 
procedures. Study drug must be dispensed or administered according to procedures 
described herein. Only patients enrolled in the study may receive study drug, in 
accordance with all applicable regulatory requirements. Only authorized study center 
personnel may supply or administer study drug. All study drugs must be stored in a 
secure area with access limited to the investigator and authorized study center 
personnel and under physical conditions that are consistent with study drug-specific 
requirements. The study drug must be stored as specified on the label and according 
to the latest version of the IB. 
5.8 Product Accountability 
The investigator is responsible for study drug accountability, reconciliation, and 
record maintenance. In accordance with all applicable regulatory requirements, the 
investigator or designated study center personnel must maintain study drug 

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accountability records throughout the course of the study. This person(s) will 
document the amount of study drug received from the sponsor, the amount supplied 
and/or administered to and returned by patients, if applicable. After completion of the 
study, all unused product will be inventoried and packaged for return shipment by the 
hospital unit pharmacist. The inventoried supplies will be returned to the sponsor or 
destroyed on site after receiving written sponsor approval. 
5.9 Assessment of Compliance 
Patients will receive FN-1501 by intravenous infusion at the investigational site as 
outlined in the Study Assessment and Procedure Schedule (Table 2). All visits and 
treatment administrations will be recorded. 
6 Concomitant Medications and Nondrug Therapies 
6.1 Permitted Medications 
All concomitant medications taken during the study will be recorded in the eCRF with 
indication, dose information, and dates of administration according to the Study 
Assessment and Procedure Schedule (Table 2). All prescription or non-prescription 
(over the counter) medications, as well as, vitamins, herbs and supplements taken, any 
special diets and alcohol use should be collected.  
6.2 Prohibited Medications 
Administration of all other anti-cancer therapy (cytotoxic, biologic, radiotherapy, or 
hormone therapy other than for replacement) while on treatment in this study is 
prohibited. Palliative radiotherapy for non-targeted lesions is permitted.  
Bisphosphonate use is permitted if the patient has already been on it for three or more 
months and on a stable dose. Corticosteroid courses of limited duration (2 weeks or 
less) are permitted, if used to treat a concomitant (non-cancer) medical condition. 
During study treatment, drugs known to prolong the QT/QTc interval should be 
avoided unless there is no alternative treatment available, in accordance with ICH E14 
[9]. If such a drug must be used, written approval from the sponsor’s medical monitor 
is required. A list of drugs with QTc prolongation potential is presented in Table 4. A 
full list is provided through the Arizona Center for Education and Research on 
Therapeutics (CERT; “Drugs That Prolong the QT interval and/or Induce Torsades de 
Pointes”): Available at: 
https://crediblemeds.org/index.php/tools/pdfdownload?f=cql_en  

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Table 4: Drugs with QTc prolongation potential 
Antipsychotics 
Type IA 
antiarrhythmics 
Type IC 
antiarrhythmics 
Class III 
antiarrhythmics 
Chlorpromazine 
Haloperidol 
Droperidol 
Quetiapine 
Olanzapine 
Amisulpride 
Thioridazine 
Quinidine 
Procainamide 
Disopyramide 
Flecainide 
Encainide 
Sotalol 
Amiodarone 
Tricyclic 
antidepressants 
Other 
antidepressants 
Antihistamines 
Other 
Amitriptyline 
Doxepin 
Imipramine 
Nortriptyline 
Desipramine 
Mianserin 
Citalopram 
Escitalopram 
Venlafaxine 
Bupropion 
Moclobemide 
Diphenhydramine 
Astemizole 
Loratidine 
Terfanadine 
Chloroquine 
Hydroxychloroquine 
Quinine 
Macrolides  
Erythromycin 
Clarithromycin 
 
While the primary metabolic pathway for FN-1501 involves the CYP3A isoform, 
preliminary in vitro screening assays revealed that FN-1501 is not a strong inhibitor 
nor a strong inducer of human CYP isoenzymes tested. The use of drugs that are 
strong CYP3A4 inhibitors or inducers is prohibited (Table 5). Patients who require 
moderate CYP3A4 inhibitors during the study should be closely monitored. Please 
refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/ for a complete list of 
CYP3A inhibitors. 
Table 5: Prohibited Medications 
Strong CYP3A inhibitors 
Indinavir 
telithromycin 
suboxone 
nelfinavir 
Itraconazole 
ketoconazole 
ritonavir 
saquinavir 
nefazodone  
clarithromycin 
 
 
Strong CYP3A inducers 
Carbamazepine 
rifampicin 
phenobarbital 
phenytoin 
St. John’s wort 
 
 
 
   Abbreviations: CYP = cytochrome P450 

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6.3 Other Medications to be Used with Caution 
Gene expression data showed that FN-1501 is an inducer of CYP1A2 at the 
concentration of 0.100 µM. FN-1501 also showed weak inhibition on CYP2C8 (IC50: 
38.8 µM). Investigators should be aware that FN-1501 has the potential to interfere 
with the appropriate metabolism of medications that rely on these isoenzymes. Please 
refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/ for the medication list. 
7 Safety, Pharmacokinetic, Pharmacodynamic, and Other Assessments 
A signed, written informed consent must be obtained prior to screening assessments 
and before any study-specific assessments are initiated. The study-specific 
assessments and procedures are shown in Table 2. The PK sampling, vital sign and 
ECG time points are presented in Table 2 and Table 3. Demographic and Baseline 
Assessments will include date of birth, race, height (in cm), body weight (in kg), and 
body mass index (BMI [in kg/m2]). For height and weight measurements, the patient 
will be allowed to wear indoor daytime clothing with no shoes. This data will be 
captured in the eCRF and database. After giving consent, patients will be required to 
undergo a medical screen to determine whether they are eligible to participate in the 
study according to the criteria listed in Section 4.2. Screening assessments will be 
completed within 21 days prior to the first dose of the study drug, except that 
radiological scans of tumor can be within 42 days prior to the first dose (Section 7.4). 
Screening assessments completed within 72 hours of administration can be used as 
Day 1 of Cycle 1 assessments as indicated in Table 2. The screening assessments will 
include: 
 Demographic data 
 Medical history & baseline conditions 
 Vital signs (SBP, DBP, pulse rate, temperature, and respiratory rate) 
 Height and weight (BMI calculation) 
 Complete physical exam 
 ECOG performance status 
 12-lead ECG 
 Review of concurrent medications 
 CT or MRI  
 Disease assessment for Solid Tumors or AML 
 Pregnancy test for women of childbearing potential 

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 Hematology 
 Blood chemistry plus serum amylase and lipase tests 
 Bone marrow biopsy for related assessments for patients with AML (see 
Section 7.4) 
 Coagulation test 
 Urinalysis 
 Recording of AEs and SAEs 
The above-mentioned data will be captured in the source documents and entered into 
the eCRF. All tests will be done by local laboratories. Any results falling outside the 
normal range will be repeated at the discretion of the investigator. 
7.1 Assessments During the Treatment Period 
Routine safety assessments include vital signs, weight, physical exam, and AE 
assessment will be performed at every visit. Other safety assessments include 12-lead 
ECG, bloodwork, disease assessments, bone marrow biopsy for related assessments 
for patients with AML, and urinalysis will be performed as indicated in Table 2.   
7.1.1 Local Laboratory Evaluation 
Laboratory assessments will be performed at a local certified laboratory at the time 
points specified in Table 2. Laboratory assessments need not be repeated on Day 1 if 
these assessments were completed for screening within 72 hours prior to the first 
administration. Required laboratory assessments are listed in Table 6.  

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Table 6: Clinical laboratory assessments 
Blood Chemistry 
Hematology  
Coagulation  
Urinalysis 
(dipstick) 
Alkaline phosphatase 
Alanine 
aminotransferase 
Aspartate 
aminotransferase 
Albumin 
Bicarbonate 
Electrolytes (Ca, K, 
Na, Cl, P) 
Creatinine 
Glucose 
Lactate 
dehydrogenase 
Magnesium 
Phosphorus 
Serum amylase* 
Serum lipase* 
Total protein 
Total bilirubin 
Urea  
Full and differential 
blood count 
Red blood cell count 
Hematocrit 
Hemoglobin 
Mean corpuscular 
hemoglobin 
Mean corpuscular 
hemoglobin 
concentration 
Mean corpuscular 
volume 
Platelet counts 
White blood cell 
count with 
differential 
Neutrophil count 
 
Prothrombin time 
Partial thromboplastin 
time 
 
Appearance 
pH 
Specific 
gravity 
Glucose 
Protein 
Ketones  
Blood cells 
Abbreviations: Ca = calcium; Cl = chloride; K = potassium; Na = sodium  
* These tests will be conducted together with blood chemistry.  
Laboratory results should be assessed by the Investigator. In the event of neutropenia 
(ANC <1000/mm3), thrombocytopenia (platelets <50,000/mm3), or Grade 3 clinical 
chemistry toxicity, the relevant assessments will be conducted as frequently as the 
Principal Investigator feels is needed until toxicity resolves to ≤ Grade 2. If 
warranted, additional testing can also be done, or the relevant tests done more 
frequently in accordance with institutional guidelines. All patients who have any 
Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study must be 
followed up until they have returned to Grade 1 or Grade 2, unless these are not likely 

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to improve due to the underlying disease. On routine urinalysis, if urine protein is 
≥ 2+ by dipstick, then 24-hour urine for total protein and a random urine sample for 
total protein and creatinine will be obtained. If urine protein is > 2 g/24 hours, study 
drug administration will be interrupted until it returns to ≤ 2 g/24 hours. If urine 
protein is ≤ 2 g/24 hours, further clinical evaluation and/or more frequent testing may 
be performed as clinically indicated. A random urine protein to creatinine ratio can 
serve as a reliable surrogate for the 24-hour urine protein when following patients 
with urine protein of ≤ 2 g, documented by a 24-hour urine collection. In such cases, 
the 24-hour urine for total protein should be repeated only if a clinically significant 
increase is observed in the random urine protein to creatinine ratio. After week 9, this 
test will be performed as clinically indicated. 
7.1.2 Physical Examination and Vital Signs 
A complete or targeted physical examination, vital signs (SBP, DBP, pulse rate, 
temperature, and respiratory rate), and weight examination will be performed at the 
time points specified in Table 2. 
Complete physical examination includes assessments of cardiovascular, respiratory, 
abdominal and neurological systems as well as lymph nodes/spleen, skin, oropharynx 
and extremities. Targeted physical examinations should be limited to systems of 
clinical relevance (i.e., cardiovascular, respiratory, lymph nodes, liver, and spleen), 
and those systems associated with clinical signs/symptoms. 
7.1.3 Electrocardiogram 
A 12-lead ECG will be performed in triplicate at Screening, on Cycle 1, Day 1, Cycle 
2, Day 1. Thereafter, triplicate is only if clinically indicated (i.e., prolonged QTc 
interval) as detailed in Table 2. ECGs will be performed on the days specified in 
Table 2 and time points specified in Table 3. Other ECGs may be performed as 
clinically indicated. Patients should be in the supine position for at least 10 minutes 
prior to having ECGs performed and remain in that position for the duration of the 
test. 
Patients with significant QTc prolongation to undergo 12-lead ECG as detailed in 
Table 2. Significant QTc prolongation will be defined as an interval > 500 msec; an 
interval which increases by ≥ 60 msec over baseline, and/or decreased by 50 msec 
below pre-dose recording. The ECG tracing should be examined and interpreted by a 
trained physician. 
If prolongation of QT or QT interval corrected for heart rate (QTc) is noted during the 
first 2 weeks, triplicate 12 lead ECGs will be conducted weekly during Cycle 2, and 
then once every 3 weeks before administration and 5-15 minutes after administration 

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on Day 1 of every cycle from Cycle 3 onwards, until discontinuation of FN-1501 
treatment. 
If a patient has significant QTc prolongation: 
 He/she will suspend study drug administration 
 The patient will be medically assessed, treated appropriately, and closely 
followed (ECGs at least three times per week) until the QT and QTc 
interval return to within 30 msec of baseline 
 The medical monitor will be consulted prior to administering further doses 
or re-challenging 
 The medical monitor will be consulted prior to administering higher doses 
7.1.4 Computed Tomography 
CT scan with contrast will be performed to assess all known diseases in patients with 
solid tumors. CT scans must encompass neck, chest, abdomen, and pelvis and include 
oral or intravenous contrast. MRI may be used in place of CT in clinical scenarios 
where anatomical location of an evaluable lesion (such as soft tissue) precludes 
accurate measurement by CT. The CT scan will be used for disease assessment by the 
investigator at each study center. For patients who discontinue early, a CT scan will 
be performed at the end of study visit if the previous scan was more than 3 months 
ago. Note: CT scans do not apply to patients with AML. 
7.1.5 Adverse Events 
All AEs and SAEs, regardless of the relationship to the study drug, will be collected 
from consenting patients, starting from signed informed consent form until 30 days 
after their last dose of FN-1501, or until resolution of all study drug related AEs, 
whichever is longer. 
7.2 Safety 
Measurements used to evaluate safety will include vital signs, clinical laboratory tests, 
12-lead ECG, and physical examinations. Throughout the study, the study center 
personnel will be monitoring AEs. AEs and toxicities will be graded according to NCI 
CTCAE, Version 4.03. 
7.2.1 Pregnancy 
7.2.2.1 Pregnancy Testing 
A serum pregnancy test will be performed at screening and a urine pregnancy test at 
the time points specified in Table 2 in women of childbearing potential. Any female 
patient who is pregnant will not be eligible for the study.  

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The results of pregnancy tests will be recorded in the database. 
7.2.2.2 Time Period for Collecting Pregnancy Information 
The time period for collecting information on whether a pregnancy occurs is from 
screening to the 30-day post-study follow-up/end of study visit. Information on 
pregnancies identified prior to the study drug administration does not need to be 
reported to the sponsor. 
7.2.2.3 Action to be Taken if a Pregnancy Occurs 
A patient who has a positive pregnancy test result at any time after the study drug 
administration will be immediately withdrawn from participation in the study. All 
post-study assessments will be collected at the time of discontinuation. The 
investigator, or his/her designee, will collect pregnancy information on any female 
patient or a female partner of a male patient who becomes pregnant while 
participating in this study. 
The investigator, or his/her designee, will record pregnancy information on the 
appropriate form and submit it to the sponsor within 24 hours of learning of a 
patient’s pregnancy. The patient will also be followed to determine the outcome of the 
pregnancy. Information on the status of the mother and child will be forwarded to the 
sponsor. Generally, follow-up will be no longer than 6 to 8 weeks following the 
estimated delivery date. Any premature termination of the pregnancy will be reported. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy for medical reasons will be 
recorded as an SAE, as described in Section 9.6 and will be followed as described in 
Section 9.8. 
A spontaneous abortion is always considered to be an SAE and will be reported. 
Furthermore, any SAE occurring because of a post-study pregnancy and which is 
considered reasonably related to the study drug by the investigator, will be reported to 
the sponsor as described in Section 9.8. While the investigator is not obligated to 
actively seek this information in former patients, he/she may learn of an SAE through 
spontaneous reporting. 
7.3 Safety Follow-up Assessment 
Approximately 30 days after the last administration of the study drug, all patients 
should return for a final evaluation. Assessments to be performed are presented in 
Table 2. 
Any abnormal finding of clinical consequence and not related to the disease 
progression will be monitored until resolution or baseline status. 

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7.4 Efficacy 
Efficacy is not a primary objective of this study. Anti-tumor activities will be 
evaluated in solid tumors by treating investigators according to RECIST version 1.1, 
performance status, CT/MRI image and tumor marker (if applicable) at designated 
time points and time of event (Table 2). CR, PR, SD, PFS, and duration of response 
will be summarized. 
In patients with AML, response will be evaluated according to the AML response 
criteria at designated time points and time of event (Table 2) [5]. Bone marrow biopsy 
for related assessments will be performed in patients with AML at the end of every 
other cycle, at the end of the study or at time of relapse. Based on the patient’s clinical 
condition, complete blood counts or bone marrow assessments may occur more 
frequently based on investigator’s judgment. 
In patients with AML only:  
Bone marrow biopsy for related assessments:   
 Bone marrow cellularity 
 Total Cells Counted 
 Blasts in Marrow 
 Classical Cytogenetic Analysis 
7.5 Pharmacokinetics 
Blood samples will be collected to determine the plasma concentration and describe 
the PK profile of FN-1501 and for a preliminary analysis of major metabolites. 
The maximum total amount of blood taken for the PK analysis will be approximately 
4 mL. These samples will be collected at the time points presented in Table 3. Should 
a patient undergo an intra-patient dose escalation, additional PK samples may be 
collected (in addition to those listed in Table 3) following the same schedule in  
Table 3. Frozen plasma samples should be shipped as soon as possible after collection 
since exposure will be monitored while the study is ongoing. 
Cannulation for blood sampling for PK will be performed. Blood will be collected via 
the intravenous cannula pre-dose and at the time points specified in Table 3. The 
actual time each sample was collected will be captured to the nearest minute in the 
eCRF and recorded in the database. 
Details concerning handling of the PK plasma samples, including labeling and 
shipping instructions will be provided in the Study Manual. Blood samples (4 mL) for 

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PK analysis will be collected into plastic collection tubes with potassium 
ethylenediaminetetra acetic acid. Blood samples will be immediately chilled on 
crushed ice. Plasma will be separated by centrifugation (at approximately 1,000 × g 
for 10 to 15 minutes at 4°C) and will be transferred to labeled polypropylene storage 
tubes. Samples will be immediately frozen in an upright position to keep the plasma 
in the bottom of the tube. Samples must remain frozen in a freezer set at or 
below -70°C and in a box with dry ice during shipping. 
Prior to sample collection, the collection tube and plasma storage tube must be labeled 
with the corresponding labels provided by the sponsor. The labels must be placed 
along the length of the tube so they can be read easily. Tape must not be used to 
secure the labels as the tube will not fit into the auto-analyzer test tube rack. The 
labels are of high quality and will not peel off the tube even under extreme conditions. 
Should a drug-drug interaction (DDI) between FN-1501 and a concomitant 
medication be suspected, further blood samples for PK analyses may be collected to 
characterize the extent of the interaction. 
Samples will be shipped to the central laboratory where all samples will be analyzed 
for plasma concentrations of FN-1501 and M3 using a validated method. 
7.6 Appropriateness of Measurements 
All safety, efficacy and PK assessments used in this study are standard, i.e., widely 
used and generally recognized as reliable, accurate, and relevant. 
8 Quality Control and Quality Assurance 
The sponsor is responsible for implementing and maintaining quality assurance and 
quality control systems with written Standard Operating Procedures (SOPs). Quality 
control will be applied to each stage of data handling. The following steps will be 
taken to ensure the accuracy, consistency, completeness, and reliability of the data: 
 Investigator meeting(s) 
 Certified local laboratories for laboratory measurements and ECGs 
 Study center initiation visit 
 Early study center visits post-enrollment 
 Routine study center monitoring 
 Ongoing study center communication and training 
 Data management quality control checks 
 Continuous data acquisition and cleaning 

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 Internal review of data 
 Quality control check of the final clinical study report 
In addition, the sponsor and/or the Clinical Research Organization (CRO) clinical 
quality assurance department may conduct periodic audits of the study processes, 
including, but not limited to the study center, study center visits, central laboratories, 
vendors, clinical database, and the final clinical study report. When audits are 
conducted, access must be authorized for all study-related documents including 
medical history and concomitant medication documentation to authorized sponsor’s 
representatives and regulatory authorities. 
8.1 Monitoring 
In accordance with applicable regulations, Good Clinical Practice (GCP), and the 
sponsor’s procedures, the sponsor and/or CRO monitors will contact the study center 
prior to the patient enrollment to review the protocol and data collection procedures 
with study center personnel. In addition, the monitor will periodically contact the 
study center, including conducting on-site visits. The extent, nature and frequency of 
on-site visits will be based on such considerations as the study objective and/or 
endpoints, the purpose of the study, study design complexity, and enrollment rate. 
During these contacts, the monitor will: 
 Check the progress of the study. 
 Review study data collected. 
 Conduct source document verification. 
 Identify any issues and address their resolution 
This will be done to verify that the: 
 Data are authentic, accurate, and complete. 
 Safety and rights of patients are being protected. 
 Study is conducted in accordance with the currently approved protocol 
(and any amendments), GCP, and all applicable regulatory requirements. 
The investigator agrees to allow the monitor direct access to all relevant documents 
and to allocate his/her time and the time of his/her personnel to the monitor to discuss 
findings and any relevant issues. 
At study closure, monitors will also conduct all activities described in Section 12.1. 

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8.2 Protocol Amendment and Protocol Deviation 
Amendments to the protocol that entail corrections of typographical errors, 
clarifications, changes in study personnel, and minor modifications that have no 
impact on the safety of patients or the conduct of the study will be classed as 
administrative amendments and will be submitted to the Institutional Review Board 
(IRB)/ Independent Ethics Committee (IEC) for information only. Amendments that 
are classed as substantial amendments must be submitted to the appropriate 
Regulatory Authorities and the IRBs/IECs for approval. 
The sponsor must be informed of any protocol deviations and/or violations. The 
deviation/violation and the reasons will be included in the clinical study report. The 
investigator is responsible for reporting of protocol deviations to the IRB/IEC and in 
accordance with applicable Regulatory Authority. 
8.3 Data Management/Coding 
Data generated within this clinical study will be handled according to the relevant 
SOPs of the data management and biostatistics departments of CRO. 
An electronic data capture (EDC) system will be used for this study, meaning that all 
eCRF data will be entered in electronic forms at the study center. Data collection will 
be completed by authorized study center personnel designated by the investigator. 
Appropriate training and security measures will be completed with the investigator 
and all authorized study center personnel prior to the study being initiated. 
The eCRFs should always reflect the latest observations of the patients participating 
in the study. Therefore, the eCRFs are to be completed as soon as possible during or 
after the patient’s visit. To avoid inter-observer variability, every effort should be 
made to ensure that the same individual who made the initial baseline determinations 
completes all safety evaluations. The investigator must verify that all data entries in 
the eCRFs are accurate and correct. If some assessments are not done, or if certain 
information is not available or not applicable or unknown, the investigator should 
indicate this in the eCRF. The investigator will be required to electronically sign off 
on the clinical data once complete. 
The monitor will review the eCRFs and evaluate them for completeness and 
consistency. The eCRF will be compared with the source documents to ensure that 
there are no discrepancies. All entries, corrections, and alterations are to be made by 
the responsible investigator or his/her designee. The monitor cannot enter data in the 
eCRFs. Once clinical data has been entered in the eCRF, any corrections or alterations 
to the data fields will be traceable via an audit trail, meaning that the reason for 
change, the name of the person who performed the change, together with time and 
date will be logged. Roles and rights of the study center personnel responsible for 

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entering the clinical data into the eCRF will be determined in advance. If additional 
corrections are needed, the responsible monitor or data manager will raise a query in 
the EDC application. The appropriate study center personnel will respond to any 
queries raised. 
The eCRF is essentially considered a data entry form and should not constitute the 
original (or source) medical records unless otherwise specified. Source documents are 
all documents used by the investigator or hospital that relate to the patient’s medical 
history, that verify the existence of the patient, the inclusion and exclusion criteria and 
all records covering the patient’s participation in the study. They include laboratory 
notes, ECG results, memoranda, pharmacy dispensing records, patient files, etc. 
The investigator is responsible for maintaining source documents. These will be made 
available for inspection by the study monitor at each monitoring visit. The 
investigator must submit a completed eCRF for each patient who receives the study 
drug, regardless of the duration. Patients will be given a subject identification number 
to maintain anonymity. All supportive documentation submitted with the eCRF, such 
as laboratory or hospital records, should be clearly identified with the study and 
subject identification number. Any personal information, including patient name, 
should be removed or rendered illegible to preserve individual confidentiality. 
Electronic CRF records will be automatically appended with the identification of the 
creator, by means of their unique User ID. Records will be electronically signed by 
the investigator to document his/her review of the data and acknowledgement that the 
data are accurate. This will be facilitated by means of the Investigator’s unique User 
ID and password; date and time stamps will be added automatically at the time of the 
electronic signature. If an entry on an eCRF requires change, the correction should be 
made in accordance with the relevant software procedures. All changes will be fully 
recorded in a protected audit trail, and a reason for the change will be required. 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 
Version 17.0 or higher. Concomitant medications will be coded using the WHO Drug 
Dictionary. Concomitant diseases/medical history will be coded using the MedDRA 
Version 17.0 or higher. 
8.4 Quality Assurance Audit 
To ensure compliance with GCP and all applicable regulatory requirements, the 
sponsor may conduct a quality assurance audit. Regulatory agencies may also conduct 
a regulatory inspection of this study. Such audits/inspections can occur at any time 
during or after completion of the study. If an audit or inspection occurs, the 
investigator and institution agree to allow the auditor/inspector direct access to all 

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relevant documents and to allocate his/her time and the time of his/her personnel to 
the auditor/inspector to discuss findings and any relevant issues. 
9 Adverse Event and Serious Adverse Event 
The investigator is responsible for the detection and documentation of events meeting 
the criteria and definition of an AE or SAE as provided in this protocol. During the 
study, when there is a safety evaluation, the investigator or study center personnel will 
be responsible for detecting AEs and SAEs, as detailed in this section of the protocol. 
AE and SAE collection are to begin at the time of patient consent and continue until 
30 days after last dose of FN-1501, or until resolution of all study drug-related AEs. 
9.1 Definition of an Adverse Event 
Any untoward medical occurrence in a patient or clinical investigation patient, 
temporally associated with the use of a medicinal product, whether or not considered 
related to the medicinal product, is considered AE. An AE can therefore be any 
unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease (new or exacerbated) temporally associated with the use of a 
study drug. Examples of an AE include: 
 Significant or unexpected worsening or exacerbation of the 
condition/indication under study. 
 Exacerbation of a chronic or intermittent pre-existing condition including 
either an increase in frequency and/or intensity of the condition. 
 New conditions detected or diagnosed after study drug administration even 
though it may have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected interaction. 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
study drug or a concurrent medication. 
 Significant failure of expected pharmacological or biological action. See 
Section 9.3 for additional information. 
Examples of an AE do not include: 
 Medical or surgical procedure (e.g., endoscopy, appendectomy); the 
condition that leads to the procedure is an AE. 
 Situations where an untoward medical occurrence did not occur (social 
and/or convenience admission to a hospital). 
 Anticipated day-to-day fluctuations of pre-existing disease(s) or 
condition(s) present or detected at the start of the study that do not worsen.  

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 The disease/disorder being studied, or expected progression, signs, or 
symptoms of the disease/disorder being studied, unless more severe than 
expected for the patient’s condition. 
9.2 Definition of a Serious Adverse Event 
An SAE is any untoward medical occurrence that, at any dose: 
 Results in death. 
 Is life-threatening. 
NOTE: The term “life-threatening” in the definition of “serious” refers to an event in 
which the patient was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe. 
 Requires hospitalization or prolongation of existing hospitalization. 
NOTE: In general, hospitalization signifies that the patient has been detained at the 
hospital or emergency ward for observation and/or treatment that would not have been 
appropriate in the physician’s office or out-patient setting. Complications that occur 
during hospitalization are AEs. If a complication prolongs hospitalization or fulfills 
any other serious criteria, the event is serious. When in doubt as to whether 
“hospitalization” occurs or is necessary, the AE should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an SAE. 
 Results in disability/incapacity. 
NOTE: The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. This definition is not intended to include experiences 
of relatively minor medical significance such as uncomplicated headache, nausea, 
vomiting, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may 
interfere or prevent everyday life functions, but do not constitute a substantial 
disruption. 
 Is a congenital anomaly/birth defect. 
 Medical or scientific judgment should be exercised in deciding whether 
reporting is appropriate in other situations, such as important medical 
events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the patient or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the 
above definition. These should also be considered serious. Examples of 
such events are invasive or malignant cancers, intensive treatment in an 
emergency room or at home for allergic bronchospasm, blood dyscrasia or 

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convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse. 
9.3 Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events 
Abnormal laboratory findings (e.g., clinical chemistry, hematology, and urinalysis) or 
other abnormal assessments (e.g., ECGs, vital signs, etc.) that are judged by the 
investigator as clinically significant will be recorded as AEs or SAEs if they meet the 
definition of an AE or an SAE. Clinically significant abnormal laboratory findings or 
other abnormal assessments that are detected during the study or are present at 
baseline and significantly worsen following the start of the study will be reported as 
AEs or SAEs. However, clinically significant abnormal laboratory findings or other 
abnormal assessments that are associated with the disease being studied, unless 
judged by the investigator as more severe than expected for the patient’s condition or 
that are present or detected at the start of the study and do not worsen, will not be 
reported as AEs or SAEs. The investigator will exercise his/her medical and scientific 
judgment in deciding whether an abnormal laboratory finding or other abnormal 
assessment is clinically significant. 
9.4 Time Period, Frequency, and Method of Detecting Adverse Events and 
Serious Adverse Events 
Patients will be assessed for AEs and SAEs beginning from the time of patient 
consent, and continue until 30 days after last dose of FN-1501, or until resolution of 
all study drug related AEs. 
All AEs and SAEs will be recorded in the source documents. All AEs and SAEs will 
be reported in the eCRF. 
9.5 Recording of Adverse Events and Serious Adverse Events 
When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (e.g., hospital progress notes, laboratory, and diagnostics reports) 
relative to the event. The investigator will then record all relevant information 
regarding an AE or SAE in the eCRF. It is not acceptable for the investigator to send 
photocopies of the patient’s medical records to the sponsor in lieu of completion of 
the appropriate AE or SAE eCRF pages. However, there may be instances when 
copies of medical records for certain cases are requested by the Safety Specialist In 
this instance, all patient identifiers will be blinded on the copies of the medical 
records prior to submission to the sponsor. 
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In such cases, the diagnosis should be 

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documented as the AE or SAE and not the individual signs/symptoms. AEs are 
independent components of the study. 
9.6 Evaluating Adverse Events and Serious Adverse Events 
9.6.1 Assessment of Intensity 
The investigator will assess the intensity for each AE and SAE reported during the 
study. When applicable, AEs and SAEs should be assessed and graded based upon the 
NCI CTCAE Version 4.03. 
9.6.2 Assessment of Causality 
The investigator is obligated to assess the relationship between the study drug and the 
occurrence of each AE or SAE. The investigator will use clinical judgment to 
determine the relationship. Alternative causes, such as natural history of the 
underlying diseases, concomitant therapy, other risk factors, and the temporal 
relationship of the event to the study drug will be considered and investigated. The 
investigator will also consult the IB and/or Product Information for marketed products 
in determining his/her assessment. 
There may be situations when an SAE has occurred and the investigator has minimal 
information to include in the initial report to the sponsor. However, it is very 
important that the investigator always assesses the causality for every event prior to 
transmission of the SAE eCRF to the sponsor. The investigator may change his/her 
opinion of causality in light of follow-up information, and may amend the SAE eCRF 
accordingly. The causality assessment is one of the criteria used when determining 
regulatory reporting requirements. 
The investigator will provide the assessment of causality as per instructions on the 
SAE eCRF. The categories of causality assessment are: Not Related, Possibly 
Related, and Probably Related. 
9.7 Follow-Up of Adverse Events and Serious Adverse Events 
After the initial AE or SAE report, the investigator is required to proactively follow 
each patient and provide further information to the sponsor on the patient’s condition. 
All AEs and SAEs documented at a previous visit/contact and which are designated as 
ongoing, will be reviewed at subsequent visits/contacts. 
All AEs and SAEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the patient is lost to follow-up. Once 
resolved, the appropriate AE or SAE eCRF page(s) will be updated. The investigator 
will ensure that follow-up includes any supplemental investigations as may be 
indicated to elucidate the nature and/or causality of the AE or SAE. This may include 

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additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
The sponsor may request that the investigator perform or arrange for the conduct of 
supplemental measurements and/or evaluations to elucidate as fully as possible the 
nature and/or causality of the AE or SAE. The investigator is obligated to assist. If the 
patient dies during the study or during a recognized follow-up period, the sponsor will 
be provided with a copy of any post-mortem findings, including histopathology. 
New or updated information will be recorded on the originally completed SAE eCRF, 
with all changes signed and dated by the investigator. The updated SAE eCRF should 
be resent to the sponsor within the time frames outlined in Section 9.8. 
9.8 Prompt Reporting of Serious Adverse Events 
9.8.1 Timeframes for Submitting Serious Adverse Events 
SAEs will be reported promptly in the eCRF as described in Table 7 once the 
investigator determines that the event meets the protocol definition of a SAE.  
Table 7: Timeframe for Reporting Serious Adverse Events to the Sponsor 
Type of SAE* 
Initial SAE 
report 
Document 
Follow-up SAE 
report 
Document  
Timeframe  
24 hours of 
investigator’s 
knowledge 
SAE form 
(eCRF) 
ASAP 
SAE form 
(eCRF) 
Update 
Abbreviations: ASAP = As soon as possible eCRF = electronic case report form; SAE = 
serious adverse event 
*Pregnancy will be reported as SAE and follow the same timeframe. 
9.8.2 Completion and Transmission of the Serious Adverse Event Report 
Once an investigator becomes aware that an SAE has occurred in a patient, he/she 
will report the information into the eCRF within 24 hours as outlined in Section 9.8.1. 
The SAE form in the eCRF should be completed as thoroughly as possible with all 
available details of the event, and the sponsor should be informed within the 
designated timeframes. If the investigator does not have all information regarding an 
SAE, he/she will not wait to receive additional information before notifying the 
sponsor of the event and completing the form. The form will be updated when 
additional information is received. 

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The investigator will always provide an assessment of causality at the time of the 
initial report as described in Section 9.6.2. 
All SAEs should be reported through eCRF. In rare circumstances that eCRF cannot 
be accessed temporarily, paper SAE form should be submitted to meet the timeline 
and the site must enter the information from the paper SAE form into eCRF as soon as 
the eCRF becomes available. In the absence of facsimile equipment, notification by 
telephone is acceptable, which must be followed by an overnight email addressed to 
Clinipace Safety Group attaching a copy of the SAE form Initial notification via the 
telephone does not replace the need for the investigator to complete and sign the SAE 
form within the time frames outlined in Section 9.8.1. 
Safety Group contact information is available in the Protocol Contact List available in 
the investigator’s study file. 
The following pages of the eCRF must accompany the SAE forms: “demography”, 
“medical history”, “concomitant medications”, “study medication records”, and 
“death form” (if applicable). 
9.9 Regulatory Reporting Requirements for Serious Adverse Events 
The investigator will promptly report all SAEs to the sponsor in accordance with the 
procedures detailed in Section 9.8.1. The sponsor has a legal responsibility to notify, 
as appropriate, both the local regulatory authority and other regulatory agencies about 
the safety of a product under clinical investigation. Prompt notification of SAEs by 
the investigator to the appropriate project contact for SAE receipt is essential so that 
legal obligations and ethical responsibilities towards the safety of other patients are 
met. 
The investigator, or responsible person according to local requirements, will comply 
with the applicable local regulatory requirements related to the reporting of SAEs to 
regulatory authorities and the IRB/ IEC. 
This protocol is being filed under an Investigational New Drug (IND) application with 
the US FDA. Once active, a given SAE may qualify as an IND safety report if the 
SAE is both attributable to the study drug and unexpected. In this case, all 
investigators filed to the IND (or to associated INDs for the same compound) will 
receive an expedited investigator safety report, identical in content to the IND safety 
report submitted to the FDA. 
Expedited investigator safety reports are prepared according to the sponsor’s policy 
and are forwarded to investigators as necessary. Such a report is prepared for an SAE 
that is both attributable to study drug and unexpected. The purpose of the report is to 

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fulfill specific regulatory and GCP requirements regarding the product under 
investigation. 
When a study center receives an initial or follow-up report or other safety information 
(e.g., revised IB) from the sponsor, the responsible person according to local 
requirements is required to promptly notify his/her IRB or IEC. 
9.10 Post-study Adverse Events and Serious Adverse Events 
A post-study AE or SAE is defined as any event that occurs outside of the AE/SAE 
detection period. 
Investigators are not obligated to actively seek AEs or SAEs in former patients.  
However, if the investigator learns of any SAE, including a death, at any time after a 
patient has been discharged from the study, and he/she considers the event reasonably 
related to the study drug, the investigator will promptly notify the sponsor. 
9.11 Serious Adverse Events Related to Study Participation 
An SAE considered related to study participation (e.g., procedures, invasive tests), 
even if it occurs during the post-treatment period, will be reported promptly to the 
sponsor. 
10 Data Analysis and Statistical Considerations 
10.1 Sample Size Consideration 
The number of dose levels examined and the emerging FN-1501 toxicities will 
determine the sample size. Based on toxicity data, 7 cohorts may be required to 
establish the dose of FN-1501 for phase 2 study. Assuming DLT starts to occur at the 
dose of 12.5 mg/day (4th cohort) and therefore, 6 patients will be enrolled into this and 
subsequent cohorts, it is estimated that approximately 33 patients will be required to 
establish the RP2D(s) of FN-1501. 
The number of patients in each cohort has been based on a standard 3+3 with the 
desire to obtain adequate tolerability, safety, and PK data while exposing as few 
patients as possible to the study drug and procedures. 
10.2 General Consideration for Data Analysis 
Data will be listed and summarized according to reporting standards chosen by the 
sponsor. Refer to the statistical analysis plan for details. 
10.2.1 Analysis Populations 
All patients who are exposed to FN-1501 will be included in the safety population. 
All patients who have at least one measurable concentration and for whom valid PK 
parameters can be estimated will be included in the PK population. 

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10.2.2 Interim Analysis 
No interim analysis is planned for this study. Since this is a dose escalation study, 
safety, PK, and PD data will be evaluated on an ongoing basis. 
10.2.3 Withdrawal 
Patients who are withdrawn prior to the completion of the DLT assessment period for 
reasons other than DLT will be replaced whenever possible. 
10.3 Safety Analysis 
All patients who are exposed to FN-1501 will be evaluated for safety. 
AE rates and changes in laboratory results by dose levels will be summarized in 
tabular form. AEs representing clear evidence of disease progression will not be 
considered relevant to the assessment of toxicity. 
AEs and toxicities will be graded according to NCI CTCAE, Version 4.03 or higher.  
AEs of special interest will be defined in the statistical analysis plan. SAEs, treatment 
related AEs and AEs leading to treatment discontinuation will be summarized overall. 
Hematology, clinical chemistry, coagulation and urinalysis values will be listed for 
each patient and flagged as high or low relative to the normal range, where applicable. 
Pre-dose values will be used to assess laboratory shifts occurring post-dose. A 
comparison of pre-study and post-study values will be performed to identify any 
parameters that have not returned to pre-study levels. 
AEs will be coded and grouped using the MedDRA Version 17.0 or higher. All AEs 
will be listed. 
All ECG parameters including the QT interval corrected for heart rate (QTc) will be 
listed for each patient and summarized by dose level and assessment time. Change 
from baseline will also be summarized. Relationship between dose level and QTc 
changes will be explored by graphs. Additional exposure-response analysis may be 
conducted to evaluate QT/QTc prolongation. QTc will be calculated using both 
Fridericia’s and Bazett’s formulae. 
10.4 Pharmacokinetic Analyses 
PK analyses will be conducted on patients who have received at least 1 dose of the 
study drug and have had sufficient post dose samples collected to allow estimation of 
PK parameters. PK data before the first dose at Day 1 of Cycle 1, and after the first 
dose at Day 1 of Cycle 1 (multiple time-points), Day 3 of Cycle 1, and Day 1 of Cycle 
2 will be analyzed. PK parameters will be derived using appropriate software. 

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Plasma samples will be collected according to the time points listed in Table 3. Where 
possible, the following plasma PK parameters will be determined for FN-1501 and 
major metabolites: AUC0-last, AUC0-24, AUC0-∞, Cmax, tmax, t1/2, Vd, CL, and LI. 
Plasma concentration-time data will be summarized and displayed in both tabular and 
graphical form. Concentration-time data will be analyzed with standard non-
compartmental and/or compartmental PK methods. The PK parameters for a single 
dose profile (AUC, Cmax, tmax, t1/2, CL, and Vd) will be calculated, if there are 
sufficient data. Individual patient parameter values, as well as a descriptive summary 
(mean, standard deviation, median, minimum, maximum, and the standard deviation 
and geometric mean of log-transformed parameters) by treatment group will be 
reported. Individual patient parameter values will be plotted against dose. 
Population PK data may be pooled with data from other studies to investigate any 
association between drug exposure and biomarkers or significant safety endpoints. 
Alternative dosing approach, e.g., body size-based or fixed dosing, may be evaluated 
using a population approach. The results of these analyses, if performed, may be 
reported separately. 
Dose proportionality of AUC and Cmax for FN-1501 will be assessed using the power 
model as described below and evaluated visually in graphical form: 
A linear regression model with the logarithm of the PK parameter (AUC, Cmax) as the 
dependent variable and the logarithm of the dose as the independent variable 
(log[PK]=α+β*log[Dose]) will be fitted. The model parameters (slope [β] and 
intercept [α]) will be estimated using least square regression. A minimum of 3 values 
per dose must be available for a given PK parameter to estimate dose proportionality 
with the power model. Point estimates and corresponding 2-sided 95% confidence 
intervals for the slope parameter and the intercept parameter will be provided. 
10.5 Efficacy Analyses 
Tumour response data will be listed and summarised by dose level using the 
following response categories: CR, PR, SD, progressive disease and not evaluable 
(NE) in solid tumors. Morphologic leukemia-free state in patients with AML. 
11 Ethics 
11.1 Regulatory Authority Approval 
The sponsor will submit the protocol and where necessary obtain approval to conduct 
the study from the appropriate regulatory agency in accordance with any applicable 
country-specific regulatory requirements before the study is initiated at a study center 
in that country. 

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11.2 Ethical Conduct of the Study and Ethics Approval 
This study will be conducted in accordance with GCP and all applicable regulatory 
requirements, including, where applicable, the current version of the Declaration of 
Helsinki. 
The investigator is responsible for ensuring that this protocol, the study center’s 
informed consent form, and any other information that will be presented to potential 
patients (e.g., advertisements or information that supports or supplements the 
informed consent) are reviewed and approved by the appropriate IEC/IRB. The 
investigator agrees to allow the IEC/IRB direct access to all relevant documents. The 
IEC/IRB must be constituted in accordance with all applicable regulatory 
requirements. The sponsor will provide the investigator with relevant 
document(s)/data that are needed for IEC/IRB review and approval of the study. 
Before the study drug(s) can be shipped to the study center, the sponsor must receive 
copies of the IEC/IRB approval, the approved informed consent form, and any other 
information that the IEC/IRB has approved for presentation to potential patients. 
If the protocol, the informed consent form, or any other information that the IEC/IRB 
has approved for presentation to potential patients is amended during the study, the 
investigator is responsible for ensuring the IEC/IRB reviews and approves, where 
applicable, these amended documents. The investigator must follow all applicable 
regulatory requirements pertaining to the use of an amended informed consent form 
including obtaining IEC/IRB approval of the amended form before new patients 
consent to take part in the study using this version of the form. Copies of the IEC/IRB 
approval of the amended informed consent form/other information and the approved 
amended informed consent form/other information must be forwarded to the sponsor 
promptly. 
11.3 Informed Consent 
Informed consent will be obtained before the patient can participate in the study.  
The contents and process of obtaining informed consent will be in accordance with all 
applicable regulatory requirements. 
11.4 Investigator Safety Reporting Requirements 
The investigator or CRO is responsible for reporting SAEs to the IEC/IRB, in 
accordance with all applicable regulations. Furthermore, the investigator may be 
required to provide periodic safety updates on the conduct of the study at his/her study 
center and notification of study closure to the IEC/IRB. Such periodic safety updates 
and notifications are the responsibility of the investigator and not of the sponsor. 

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12 Study Administration 
12.1 Study and Study Center Closure 
Upon completion of the study, the monitor will conduct the following activities in 
conjunction with the investigator or study center personnel, as appropriate: 
 Return of all study data to the sponsor 
 Data queries 
 Accountability, reconciliation, and arrangements for unused study drug(s) 
 Review of study records for completeness 
 Return of treatment codes to the sponsor 
 Shipment of PK samples to assay laboratories 
In addition, the sponsor reserves the right to suspend or prematurely discontinue this 
study either at a single study center or at all study centers at any time for reasons 
including, but not limited to, safety or ethical issues or severe non-compliance. If the 
sponsor determines such action is needed, the sponsor will discuss this with the 
investigator (including the reasons for taking such action) at that time. When feasible, 
the sponsor will provide advance notification to the investigator of the impending 
action prior to it taking effect. 
The sponsor will promptly inform all other investigators and/or institutions 
conducting the study if the study is suspended or terminated for safety reasons, and 
will also inform the regulatory authorities of the suspension or termination of the 
study and the reason(s) for the action. If required by applicable regulations, the 
investigator must inform the IEC/IRB promptly and provide the reason for the 
suspension or termination. 
If the study is prematurely discontinued, all study data must be returned to the 
sponsor. In addition, arrangements will be made for all unused study drug(s) in 
accordance with the applicable sponsor procedures for the study. 
Financial compensation to investigators and/or institutions will be in accordance with 
the agreement established between the investigator and the sponsor. 
12.2 Records Retention 
Following closure of the study, the investigator must maintain all study records in a 
safe and secure location. The records must be maintained to allow easy and timely 
retrieval, when needed (e.g., audit or inspection), and, whenever feasible, to allow any 
subsequent review of data in conjunction with assessment of the facility, supporting 
systems, and personnel. Where permitted by local laws/regulations or institutional 

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policy, some of these records can be maintained in a format other than hard copy 
(e.g., microfiche, scanned, electronic); however, caution needs to be exercised before 
such action is taken. The investigator must assure that all reproductions are legible, 
are a true and accurate copy of the original, and meet accessibility and retrieval 
standards, including re-generating a hard copy, if required. Furthermore, the 
investigator must ensure there is an acceptable back up of these reproductions and that 
an acceptable quality control process exists for making these reproductions. 
The sponsor will inform the investigator of the time period for retaining these records 
to comply with all applicable regulatory requirements. The minimum retention time 
will meet the strictest standard applicable to that study center for the study, as dictated 
by any institutional requirements or local laws or regulations, or the sponsor’s 
standards/procedures; otherwise, the retention period will default to 15 years. 
The investigator must notify the sponsor of any changes in the archival arrangements, 
including, but not limited to, the following: archival at an off-site facility, transfer of 
ownership of the records in the event the investigator leaves the study center, transfer 
of ownership of the study site. 
12.3 Provision of Study Results and Information to Investigators 
When the clinical study report is completed, the sponsor will provide the major 
findings of the study to the investigator. In addition, details of the study treatment 
assignment will be provided to the investigator to enable him/her to review the data to 
determine the outcome of the study for his/her patients. 
The sponsor will not routinely inform the investigator or patient of the test results, 
because the information generated from this study will be preliminary in nature, and 
the significance and scientific validity of the results will be undetermined at such an 
early stage of research. 
12.4 Information Disclosure and Inventions 
All information provided by the sponsor and all data and information generated by the 
study center as part of the study (other than a patient’s medical records) are the sole 
property of the sponsor. 
All rights, title, and interests in any inventions, know-how or other intellectual or 
industrial property rights which are conceived or reduced to practice by the study 
center personnel during or as a result of the study are the sole property of the sponsor, 
and are hereby assigned to the sponsor. 
If a written contract for the conduct of the study which includes ownership provisions 
inconsistent with this statement is executed between the sponsor and the study center, 
that contract’s ownership provisions shall apply rather than this statement. 

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All information provided by the sponsor and all data and information generated by the 
study center as part of the study (other than a patient’s medical records) will be kept 
by the investigator and other study center personnel. This information and data will 
not be used by the investigator or other study center personnel for any purpose other 
than conducting the study. 
These restrictions do not apply to: 
 Information which becomes publicly available through no fault of the 
investigator or study center personnel. 
 Information which is necessary to disclose in confidence to an IEC/IRB 
solely for the evaluation of the study. 
 Information which is necessary to disclose to provide appropriate medical 
care to a patient. 
 Study results which may be published as described in Section 12.4.1. 
If a written contract for the conduct of the study which includes provisions 
inconsistent with this statement is executed, that contract’s provisions shall apply 
rather than this statement. 
12.4.1 Publication Policy 
For multi-center studies, the first publication or disclosure of study results shall be a 
complete, joint multi-center publication or disclosure coordinated by the sponsor. 
Thereafter, any secondary publications will reference the original publication(s). 
Prior to submitting for publication, presentation, use for instructional purposes, or 
otherwise disclosing the study results generated by the study center (collectively, a 
“Publication”), the investigator shall provide the sponsor with a copy of the proposed 
Publication and allow the sponsor a period of at least 30 days (or, for abstracts, at 
least 5 working days) to review the proposed Publication. Proposed Publications shall 
not include any sponsor information other than the study results or any personal data 
on any patient, such as name or initials. 
At the sponsor’s request, the submission or other disclosure of a proposed Publication 
will be delayed a sufficient time to allow the sponsor to seek patent or similar 
protection of any inventions, know-how, or other intellectual or industrial property 
rights disclosed in the proposed Publication. 
If a written contract for the conduct of the study, which includes publication 
provisions inconsistent with this statement is executed, that contract’s publication 
provisions shall apply rather than this statement. 
 

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13 References 
1. Forbes SA, Tang G, Bindal N, et al. COSMIC (the Catalogue of somatic 
mutations in cancer): a resource to investigate acquired mutations in human 
cancer. Nuclei Acids Res. 2010, 38: D657-7. 
2. Grafone T, Palmisano M, Nicci C, et al. An overview on the role of FLT3-
tyrosine kinase receptor in acute myeloid leukemia: biology and treatment. 
Oncology review 2012, 6: e8. 
3. Kayser S and Levis MJ. FLT3 tyrosine kinase inhibitors in acute myeloid 
leukemia: clinical implications and limitations. Leuk Lymphoma 2014, 55(2): 
243. 
4. FN-1501 Investigator’s Brochure, version 1. 
5. Döhner H, Estey EH, Amadori S, et al. Diagnosis and management of acute 
myeloid leukemia in adults: recommendations from an international expert 
panel, on behalf of the European LeukemiaNet. Blood. 2010, 115(3): 453-74. 
6. RYDAPT® (midostaurin) Prescribing Information. Novartis. June 2018.  
7. ICH Guidance for Industry. S9 Nonclinical Evaluation for Anticancer 
Pharmaceuticals. October 2009. 
8. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for 
Therapeutics in Adult Healthy Volunteers. 70 FR 42346. July 2005. 
9.  ICH Guidance for Industry. E14 Clinical Evaluation of QT/QTc Interval 
Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. 
October 2015.  
 
 
 
 
 

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14 Appendices 
Appendix 1: SIGNATURE OF INVESTIGATOR 
Protocol Title 
A phase 1, multi-center, open-label, single-arm, dose-
escalation, clinical study to evaluate the safety, 
tolerability, pharmacokinetics (PK) and anti-tumor 
activity of FN-1501 monotherapy in patients with 
advanced solid tumors or relapsed/refractory Acute 
Myeloid Leukemia (AML)  
Protocol No. 
FN-1501-UP1 
 
This protocol is a confidential document of Shanghai Fosun Pharmaceutical 
Development Co., Ltd. 
I confirm that I have read and understood this protocol, and will work according to 
this protocol. I will also work consistently with the ethical principles that have their 
origin in the Declaration of Helsinki and that are consistent with good clinical 
practices (CGP) and the applicable laws and regulations. Upon acceptance of this 
document I agree that no unpublished information contained herein will be published 
or disclosed without prior written approval from Shanghai Fosun Pharmaceutical 
Development Co., Ltd. 
 
I have read this protocol in its entirety and agree to conduct the study accordingly: 
Signature of Investigator: ___________________________ Date:  ____________ 
Printed Name: ______________________________________ 
 
  
_______ 
Investigator Title: ______________________________________ 
 
 
____  
Name/Address of Center: ________________________________ 
 
 
____