Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase
Phase: PHASE1
Conditions: Gastrointestinal Cancer, Biliary Tract Cancer
Sponsor: InnoPharmax Inc.

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 4 of 86 
 
 
Protocol Synopsis 
Sponsor: 
InnoPharmax Inc. 
Investigational Product: 
D07001-softgel capsules 
Active Ingredient: 
Gemcitabine hydrochloride 
Protocol No.: 
Inno-GO-03 
Study Title: 
Open-Label, Multicenter Study of D07001-Softgel Capsules 
(Oral Gemcitabine Hydrochloride) in Subjects with Unresectable, 
Metastatic or Locally Advanced Gastrointestinal Cancer in 
Dose-Escalation Phase and in Subjects with Advanced Biliary 
Tract Cancer Following Primary Chemotherapy or Combined 
Chemoradiotherapy in Dose-Expansion Phase 
Phase of Development: 
1b/2 
Study Site(s): 
The study will be conducted in Taiwan, Korea, and the United 
States of America (USA). 
Indication(s): 
Chemotherapy following primary chemotherapy or combined 
chemoradiotherapy (CCRT) for advanced biliary tract cancer 
(BTC) (cholangiocarcinoma or gallbladder cancer) 
Objectives: 
Part 1: Dose-Escalation Phase (Phase 1b) 
Primary Objective 
 
To assess the safety and tolerability of increasing doses of 
D07001-softgel in patients with unresectable locally 
advanced or metastatic gastrointestinal (GI) cancer 
Secondary Objectives 
 
To evaluate the pharmacokinetic (PK) profile of 
D07001-softgel 
Exploratory Objectives 
 
To evaluate the preliminary data on the efficacy of increasing 
doses of D07001-softgel 
 
To investigate the effect of increasing doses of 
D07001-softgel on additional parameters such as tumor 
markers 
 
To investigate the relationship between the efficacy, safety, 
and PK of D07001-softgel and pharmacogenomic, 
pharmacoproteomic, and cellular markers, including the 
levels of immune cells, circulating endothelial progenitor 
cells and circulating tumor cells 
Part 2: Dose-Expansion Phase (Phase 2) 
Primary Objectives 
 
To assess the safety and tolerability of D07001-softgel in 
patients who have achieved stable disease or better following 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 5 of 86 
 
 
first-line chemotherapy or CCRT for unresectable metastatic 
or locally advanced BTC 
Secondary Objectives 
 
To assess the PK profile of D07001-softgel, including the 
effect of food 
Exploratory Objectives 
 
To evaluate the efficacy of D07001-softgel, as assessed by 
progression-free survival (PFS), overall survival (OS), time-
to-progression (TTP), and objective response rate (ORR; in 
patients with measurable disease at baseline only), in patients 
who have achieved stable disease or better following 
first-line chemotherapy or CCRT for unresectable metastatic 
or locally advanced BTC 
 
To investigate the effect of D07001-softgel on tumor markers 
 
To investigate the relationship between the efficacy, safety, 
and PK of D07001-softgel and pharmacogenomic, 
pharmacoproteomic, and cellular markers, including the 
levels of immune cells, circulating endothelial progenitor 
cells and circulating tumor cells 
Study Design: 
This open-label, multicenter study will be conducted in 2 parts: a 
dose-escalation phase (Part 1) and a dose-expansion phase 
(Part 2). 
In both Part 1 and Part 2, eligible patients will be assigned to 
receive oral D07001-softgel on Days 1, 3, 5, 8, 10, 12, 15, 17, 
and 19 of a 21-day cycle (9 doses per cycle).  There will be no 
gap between the cycles, e.g., the second cycle will commence 
immediately on the next day after Day 21 of the first cycle (Day 
22 overall).  Dosing on 2 consecutive days will not be allowed; 
there will be at least 1 day between 2 doses. 
Part 1: Dose-Escalation Phase (Phase 1b) 
Part 1 of the study will follow a 3+3 dose-escalation scheme 
at predefined dose levels.  There will be sequential cohorts of 
3 to 6 patients each with increasing doses of 40 mg, 60 mg, 
80 mg, 120 mg, and 160 mg per cohort.  There will be no 
intra-patient dose escalation.  Cycle 1 (21 days) is defined as the 
dose-limiting toxicity (DLT) assessment period. 
Each cohort will enroll 3 patients.  If none of the 3 patients in the 
cohort experiences a DLT, the study may proceed with dose 
escalation to the next cohort.  If 1 out of 3 patients experiences a 
DLT, 3 additional patients will be entered into that cohort for a 
total of 6 patients.  If none of the 3 additional patients in that 
cohort experiences a DLT, then the next ascending dose cohort 
may proceed.  Dose escalation to a subsequent cohort will only 
proceed after assessment of safety and tolerability data (and raw 
PK data, if available) of the preceding cohort at a review meeting 
of the Safety Board.  If ≥2 patients in a 3-6 patient cohort 
experience a DLT during Cycle 1, the maximum tolerated dose 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 6 of 86 
 
 
(MTD) is considered to have been exceeded and no additional 
patients will be treated at the current or higher doses.  In this 
case, the Safety Board may decide to evaluate an intermediate 
dose level 20 mg lower than the dose level at which ≥2 patients 
in a cohort experienced a DLT.  If an MTD is not identified 
following dose escalation to 160 mg, the intermediate dose level 
of 140 mg may also be evaluated.  If an intermediate dose level is 
evaluated, up to 6 additional patients will be enrolled at that dose 
level. 
Patients in Part 1 will continue treatment until withdrawal due to 
a DLT (Cycle 1 only), disease progression according to Response 
Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), 
withdrawn consent, or when another treatment discontinuation 
criterion is met. 
PK samples will be obtained during Cycle 1. For Cycle 1 Day 1 
and Day 15 visits, overnight fasting, except for water and 
medications is required. 
Preliminary efficacy data will be obtained in Part 1.  Tumor 
assessments by RECIST v1.1 will be conducted every 6 weeks 
relative to the first dose of study medication for all patients until 
disease progression, death, or withdrawal of consent.  Disease 
progression will be based on the Investigator’s evaluation of 
tumor assessments.  Patients who are discontinued from study 
drug for a reason other than disease progression, death, or 
withdrawal of consent are to continue tumor assessments on the 
same schedule. 
Part 2: Dose-Expansion Phase (Phase 2) 
The highest dose level of D07001-softgel tested at which <2 of 
6 patients experience a DLT will be expanded in Part 2 of the 
study.  In addition, because the highest dose level selected in 
Part 1 could lead to cumulative toxicity during treatment, the 
next lowest dose level below the highest evaluated in Part 1 at 
which <2 of 6 patients experienced a DLT will also be expanded 
for assessment in Part 2.  If an MTD is not identified in Part 1 of 
the study, the 2 dose levels used in Part 2 will be 160 mg 
and 120 mg, or 160 mg and 140 mg if the intermediate dose of 
140 mg has been evaluated in Part 1. 
In Part 2 of the study, eligible patients will be randomized in a 
1:1 ratio to receive D07001-softgel in an open-label manner at 
1 of the 2 dose levels selected for expansion.  Twenty 
(20) patients will be enrolled to each dose-expansion cohort.  
Patients will be treated until withdrawal from treatment due to 
disease progression according to RECIST v1.1, withdrawn 
consent, or when another treatment discontinuation criterion is 
met.  Patients who are discontinued from study drug for reasons 
other than disease progression or toxicity in the first 2 cycles of 
Part 2 will be replaced. 
As for Part 1, tumor assessments by RECIST v1.1 in Part 2 will 
be conducted every 6 weeks relative to the first dose of study 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 7 of 86 
 
 
medication for all patients until disease progression, death, or 
withdrawal of consent.  Disease progression will be based on the 
Investigator’s evaluation of tumor assessments.  Patients who are 
discontinued from study drug for a reason other than disease 
progression, death, or withdrawal of consent are to continue 
tumor assessments on the same schedule. 
PK samples will be obtained during Cycle 1.  For Cycle 1 Day 1 
visit, overnight fasting, except for water and medications is 
required. In addition, for all patients in the higher dose-expansion 
cohort only, the PK of D07001-softgel will be evaluated after a 
high-fat breakfast or after overnight fasting.  Patients will receive 
D07001-softgel on Cycle 1 Day 15 and Cycle 2 Day 1 in a high-
fat fed or a fasting state.  Patients will be randomized to the 
fed/fasted states in 1 of 2 sequences (Sequence 1: Cycle 1 Day 15 
high fat, Cycle 2 Day 1 fasting; Sequence 2: Cycle 1 Day 15 
fasting, Cycle 2 Day 1 high fat) with 10 patients per sequence in 
a cross-over design (20 patients overall).  PK samples will be 
taken over a period of 48 hours post-dose for the food-effect 
evaluation in this dose-expansion cohort. 
Safety, tolerability, efficacy, and PK data will be compared 
between the 2 dose-expansion cohorts to support selection of a 
recommended D07001-softgel dose for further clinical 
development as chemotherapy following primary chemotherapy 
or CCRT for unresectable metastatic or locally advanced BTC. 
Patients in Part 1 and Part 2 who are continuing to derive clinical 
benefit from study drug at the time of study closure, as assessed 
by the Investigator, will be provided access to the study drug via 
a mechanism to be determined by the Sponsor. 
Sample Size: 
No formal sample size calculations have been performed.  In 
Part 1 of the study, 3-6 patients will be enrolled to each of the 
predefined dose cohorts.  If an intermediate dose level is to be 
investigated, another 3-6 patients will be enrolled to that cohort.  
In Part 2, 40 patients will be enrolled to receive D07001-softgel 
at the 2 dose levels selected in Part 1 (20 patients at each dose 
level). 
Inclusion Criteria: 
Patients will be entered into this study only if they meet all of the 
following criteria: 
1. Provision of a signed and dated written Informed Consent 
Form (ICF) prior to any study-specific procedures 
2. Male or female patients aged 18 years or older at screening 
(aged 20 years or older in Taiwan) 
3. Histopathological or cytologic diagnosis of unresectable, 
metastatic or locally advanced GI cancer (Part 1) or 
unresectable metastatic or locally advanced BTC 
(cholangiocarcinoma or gallbladder cancer; Part 2) 
4. Part 1 only: Refractory to or have relapsed from all standard 
therapies of advanced GI malignancy  

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
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5. Part 2 only: 
a. Achieved stable disease or better, based on the 
Investigator’s assessment, in response to first-line 
systemic therapy or CCRT, with continued stable disease 
or better based on imaging studies obtained as part of 
screening  
b. Completed first-line systemic therapy (with 2-8 cycles of 
chemotherapy with a gemcitabine-based regimen) or 
CCRT, based on the local standard of care and 
preferences in the participating countries 
Note: No more than 30% of patients enrolled in Part 2 
will have received CCRT 
6. No more than 60 days have elapsed between completion of 
the prior line of chemotherapy or CCRT and enrollment 
7. Part 2 only: Patient has not received intervening systemic 
therapy since first-line treatment 
8. Eastern Cooperative Oncology Group (ECOG) Performance 
Status (PS) of 0-2 in Part 1 and 0-1 in Part 2 
9. Life expectancy is >12 weeks 
10. Adequate bone marrow function, demonstrated by: 
a. Absolute neutrophil count (ANC) ≥1,500 cell/mm3 
b. Platelet count ≥100,000 cells/mm3 
c. Hemoglobin ≥9 g/dL 
11. Adequate liver function, demonstrated by: 
a. Aspartate transaminase (AST) and alanine 
transaminase (ALT) ≤2.5 x upper limit of normal 
(ULN), or ≤5.0 x ULN in the case of liver metastases 
b. Total bilirubin ≤1.5 x ULN 
c. Albumin ≥3.0 g/dL 
d. International normalized ratio (INR) <1.5 
12. Adequate renal function, demonstrated by: 
a. Serum creatinine ≤1.5 x ULN 
b. Creatinine clearance ≥ 60mL/min calculated by 
Cockcroft-Gault formula or directly measured with 
24hr urine collection 
13. If a woman of childbearing potential, the patient has a 
negative serum pregnancy test at screening and is not 
breastfeeding 
14. If a woman of childbearing potential, patient must use a 
medically acceptable form of contraception as 2 barrier 
methods (e.g., combination of condom, diaphragm, or 
intrauterine device), hormonal contraception (estrogen or 
progesterone agents) or 1 barrier method in combination with 
spermicide.  Birth control is required 1 month prior to 
screening, for the duration of their study participation, and 
for 1 month after the end of the study; female partners of 
male patients must adhere to the same birth control methods. 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
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15. Patient is willing to comply with protocol-required visit 
schedule and visit requirements 
Exclusion Criteria: 
Patients will not be entered into this study if they meet any of the 
following criteria: 
1. Part 2 only: More than one prior chemotherapy regimen for 
unresectable metastatic or locally advanced BTC 
Note: prior radiation (with or without radiosensitizing doses 
of chemotherapy) or fluoropyrimidine chemotherapy are 
allowed as postsurgical adjuvant therapy. 
2. Part 2 only: Received any systemic therapy (chemotherapy, 
biologics, immunotherapy, or investigational agents) for 
metastatic disease other than gemcitabine-based 
chemotherapy or CCRT for locally advanced BTC 
3. Diagnosis of active malignancy (other than GI cancer 
[Part 1] or BTC [Part 2]) within the past 2 years, except 
nonmelanoma skin carcinoma and carcinoma-in-situ of 
uterine cervix treated with curative intent 
4. Prior discontinuation of gemcitabine because of pulmonary 
or hepatic toxicity or hemolytic uremic syndrome (HUS) or 
hypersensitivity, allergic reaction, or intolerance 
5. Any GI disorder which would significantly impede 
absorption of an oral agent 
6. Known brain or leptomeningeal metastases 
7. Surgery or radiation therapy within the past 28 days 
8. Part 2 only: Evidence of disease progression, based on the 
Investigator’s assessment, on the screening computed 
tomography (CT) scan or magnetic resonance imaging (MRI) 
scan 
9. Any active disease or condition that would not permit 
compliance with the protocol 
10. Residual toxicity from prior chemotherapy or CCRT that is 
Grade ≥2 (residual Grade 2 neuropathy and alopecia are 
permitted) 
11. Clinically significant cardiovascular disease (e.g., 
uncontrolled hypertension, unstable angina, congestive heart 
failure, or New York Heart Association [NYHA] Grade 2 or 
greater), or uncontrolled serious cardiac arrhythmia 
12. Patient has a history of drug or alcohol abuse within last year 
13. Patient has documented cerebrovascular disease 
14. Patient has a seizure disorder not controlled on medication 
(based on decision of Investigator) 
15. Patient received an investigational agent within 28 days of 
enrollment 
16. Patients with uncontrolled active viral, bacterial, or systemic 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 10 of 86 
 
 
fungal infection 
17. Patient has known human immunodeficiency virus (HIV) 
infection 
18. Patient has hepatitis B virus (HBV) and/or hepatitis C virus 
(HCV) infection in medical history.  If positive results are 
not indicative of true active or chronic infection, the patient 
can enter the study after discussion and agreement between 
the Investigator and the Clinical Research Organization 
(CRO) Medical Monitor 
19. Patient has received yellow fever vaccine or other live 
attenuated vaccine(s) within the 4 weeks prior to screening 
20. Patient has any other serious medical condition that, in the 
Investigator’s medical opinion, would preclude safe 
participation in, and compliance with, a clinical trial 
Primary Endpoints and 
Secondary Endpoints: 
Part 1: Dose-Escalation Phase (Phase 1b) 
Primary Endpoint: 
 
The safety endpoints are: 
o DLTs 
o MTD 
o Hematology, serum chemistry, coagulation 
parameters, and urinalysis laboratory data changes 
o Adverse event (AE)/serious adverse event (SAE) 
incidence 
o Incidence of patients experiencing toxicity Grade ≥3 
according to Common Terminology Criteria for 
Adverse Events (CTCAE) v4.03 
o Physical examination result changes 
o Vital signs changes 
o Electrocardiogram (ECG) results (including PR, 
QRS, QT, QTc, and RR intervals) 
Secondary Endpoints: 
 
PK parameters: maximum plasma concentration (Cmax), time 
to maximum plasma concentration (Tmax), area under the 
curve (AUC), elimination half-life (t1/2 el), apparent clearance 
(Cl/F), and apparent volume of distribution (Vz/F) 
Exploratory Endpoints: 
 
The efficacy endpoints are: 
o PFS 
o OS 
o TTP 
o ORR (in patients with measurable disease at baseline 
only) 
 
Tumor marker (cancer antigen [CA]-19-9, carcinoembryonic 
antigen [CEA]) levels at the times specified in the event 
schedule 

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Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
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 
Pharmacogenomic, pharmacoproteomic, and cellular analysis 
Part 2: Dose-Expansion Phase (Phase 2) 
Primary Endpoints: 
 
The safety endpoints are: 
o Dose interruptions/modifications 
o Hematology, serum chemistry, coagulation 
parameters, and urinalysis laboratory data changes 
o AE/SAE incidence 
o Incidence of patients experiencing toxicity Grade ≥3 
according to CTCAE v4.03 
o Physical examination result changes 
o Vital signs changes 
o ECG results (including PR, QRS, QT, QTc, and RR 
intervals) 
Secondary Endpoints: 
 
PK parameters: Cmax, Tmax, AUC, t1/2 el, Cl/F, and Vz/F 
Exploratory Endpoints: 
 
The efficacy endpoints are: 
o PFS 
o OS 
o TTP 
o ORR (in patients with measurable disease at baseline 
only) 
 
Tumor marker (CA-19-9, CEA) levels at the times specified 
in the event schedule 
 
Pharmacogenomic, pharmacoproteomic, and cellular analysis 
Drug Dosage/Cohorts: 
 
Part 1: Dose-Escalation Phase (Phase 1b)  
Patients will receive D07001-softgel in the fasted state 3 times 
per week in 21-day cycles.  Treatment will be administered in 
cohorts of 3-6 patients at dose levels of 40 mg, 60 mg, 80 mg, 
120 mg, and 160 mg.  Intermediate dose levels may be assessed 
in additional cohorts of 3-6 patients if considered necessary by 
the Safety Board. 
Part 2: Dose-Expansion Phase (Phase 2) 
Forty (40) patients will receive D07001-softgel in the fasted state 
3 times per week in 21-day cycles at the 2 dose levels selected in 
Part 1 of the study (20 patients per dose-expansion cohort). 
Route of Administration: 
Oral 
Study Duration: 
The study duration for an individual patient is estimated to be a 
total of approximately 17 months, including approximately 
8 months of treatment and an additional 9 months of follow up 
for survival. 
Efficacy Assessment: 
Tumor assessment will be made at screening using CT or MRI 
scans as measured by RECIST v1.1 guidelines.  Patients will be 
assessed every 2 cycles (6 weeks) starting from 0-7 calendar days 
before the start of Cycle 3 until disease progression, death, or 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
Page 12 of 86 
 
 
withdrawal of consent.  The imaging technique (CT or MRI) 
used at screening should be used throughout the study.  Patients 
will be considered evaluable for efficacy if they have at least 
1 disease assessment on study.  OS will be assessed by follow-up 
telephone contact every 6 weeks. 
Pharmacokinetic 
Assessment: 
In both Part 1 and 2 of the study, blood samples for PK will be 
collected at the following timepoints: 
 
Cycle 1 Days 1 and 15: pre-dose (within 0.5 hour before 
study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, 24, and 
48 hours post-dose 
 
Cycle 1 Day 8: pre-dose (within 0.5 hour before study drug 
administration) 
In Part 2 only, blood samples for the food-effect evaluation will 
be collected at the following timepoints: 
 
Cycle 1 Day 15 and Cycle 2 Day 1: pre-dose (within 0.5 hour 
before study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, 
24, and 48 hours post-dose. 
PK Evaluations: for both Part 1 and 2, plasma samples will be 
analyzed for gemcitabine (dFdC) and difluorodeoxyuridine 
(dFdU) concentrations using validated liquid chromatography 
(LC)/mass spectrometry (MS)/MS assays; resulting data for each 
analyte will be used to calculate the following PK parameters: 
 
dFdC and dFdU (Cycle 1 Days 1, 8, and 15): 
o AUC(0-t), AUC(0-24), AUC(0-48), AUC(0-inf), Cmax, Tmax, 
t1/2 el, %AUCextrapolated 
 
dFdC (Cycle 1 Days 1, 8, and 15): 
o Cl/F, Vz/F 
For Part 1 and 2, accumulation ratios for dFdC will be calculated 
for Day 15 relative to Day 1 for all AUC parameters and Cmax. 
For Part 1 and the lower dose-expansion cohort in Part 2, the 
accumulation ratios for dFdU will be calculated for Day 15 
relative to Day 1 for all AUC parameters and Cmax, and the 
metabolic ratio will be calculated for dFdU for Days 1 and 15 for 
all AUC parameters. 
For the food-effect evaluation in the higher dose-expansion 
cohort in Part 2, bioequivalence of the fed and fasted states will 
be evaluated for AUC(0-t) and Cmax (primary) and AUC(0-inf) 
(secondary), based on the 90% confidence interval (CI) within 
the predefined bioequivalence boundaries 0.8-1.25. 
DLT and Safety Assessment: Safety and tolerability will be assessed throughout treatment and 
the 30-day follow-up period.  National Cancer Institute (NCI) 
CTCAE v4.03 will be used for grading toxicities. 
DLT definition: In Part 1 of the study, any of the following AEs 
occurring during Cycle 1 will be classified as DLTs, if there is a 
reasonable possibility that it is related to the study drug 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
Confidential 
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 
Hematologic: 
o Grade 4 neutropenia lasting >7 days 
o Febrile neutropenia (defined as neutropenia 
Grade ≥3 and a body temp ≥38.3°C) 
o Grade ≥3 neutropenic infection 
o Grade 4 anemia 
o Grade ≥3 thrombocytopenia with bleeding 
o Grade 4 thrombocytopenia  
 
any platelet count <10,000/µL 
 
platelet count 10,000-25,000/µL for >5 days 
 
Non-hematologic: 
o Grade ≥3 toxicities that are considered clinically 
significant, except those that have not been 
maximally treated (e.g., nausea, vomiting, diarrhea*) 
or can be easily treated (e.g., electrolyte 
abnormalities). 
[*Nausea, vomiting, and diarrhea: if Grade ≥3 
toxicities persist for more than 48 h despite 
maximum treatment (loperamide, ondansetron, etc.), 
they will be considered dose limiting] 
 
Delay by more than 7 days in receiving the next scheduled 
cycle due to persisting toxicities attributable to study drug. 
 
Failure to deliver at least 6 of the planned 9 doses during 
Cycle 1 due to treatment-related toxicities. 
 
Upon the second occurrence of a toxicity leading to a dose 
hold. 
Safety will be further assessed throughout the study by: 
 
The incidence of AEs, SAEs, deaths on study, and dose 
modifications (dose reduction, interruption, or 
discontinuation of study drug) 
 
The change from baseline in clinical laboratory test results, 
(hematology, serum chemistry, coagulation parameters, 
urinalysis), and tumor markers 
 
Vital signs measurements 
 
Physical examination findings 
 
ECOG PS results 
 
ECG findings (including PR, QRS, QT, QTc, and RR 
intervals) 
Statistical Considerations: 
Analysis Sets 
Part 1 
The following analysis sets will be defined for Part 1 of the 
study: 
 
Enrolled Set (ENS): all patients who provided informed 
consent 

InnoPharmax Inc. 
Clinical Study Protocol 
Product: D07001-softgel 
Version: 4.0 
Protocol No.: Inno-GO-03 
Date: January 03, 2018 
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 
Safety Analysis Set (SAF): all patients who received at 
least 1 dose of D07001-softgel 
 
PK Analysis Set (PKS): all patients in the SAF with 
evaluable PK data, and who have no major protocol 
deviations considered to impact the analysis of the PK 
data 
Part 2 
The following analysis sets will be defined for Part 2 of the 
study: 
 
ENS: all patients who provided informed consent 
 
SAF: all patients who received at least 1 dose of study 
drug, classified by actual dose received 
 
Modified Intent-to-Treat Set (mITT): all randomized 
patients who received at least 1 dose of study drug and 
with at least 1 post-baseline disease assessment 
Note: Patients who do not meet eligibility criteria prior to 
randomization but are still randomized into the study will 
be excluded from the mITT Set. 
 
Per-Protocol Set: a subset of the mITT Set that excludes 
patients who have major protocol deviations 
 
PKS: all patients in the SAF with evaluable PK data, and 
who have no major protocol deviations considered to 
impact the analysis of the PK data 
Data for patients in Part 1 and Part 2 will be analyzed separately.   
Data for Part 1 and Part 2 will be summarized using descriptive 
statistics (number of patients, mean, median, standard deviation 
(StD), minimum, and maximum) for continuous variables and 
using frequency and percentages for discrete variables.  Unless 
otherwise specified, the baseline assessment will be the latest, 
valid pre-dose assessment available. 
Safety and PK analyses will be performed using descriptive 
statistics. 
Exploratory analyses for efficacy of each dose-expansion cohort 
in Part 2, time-to-event estimates and survival curves will be 
generated using Kaplan-Meier methodology for PFS and other 
survival outcomes.