Clinical trial NCT03573544
Conditions: Metastatic Solid Tumors Locally Advanced Solid Tumors
Keywords: mAbs monoclonal antibodies
Sponsor: OBI Pharma, Inc
Start date: 2018-05-07; Completion date: 2022-04-07
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

Detailed description:

Arms: arm 1: Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD). arm 2: Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
Interventions: intervention 1: OBI-888 intervention 2: OBI-888 intervention 3: Globo H IHC Assay
Intervention descriptions: intervention 1: For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg. intervention 2: For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level. intervention 3: This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.

Protocol documents:
Prot_000.pdf: 
OBI Pharma, Inc. 
Room W1907, 19F, #3, YuanQu Street,  
Nankang Software Park, Nangang District,  
Taipei  11503, Taiwan 
 
OBI Pharma USA, Inc. 
6020 Cornerstone Court W, Suite 200 
San Diego, CA 92121, USA  
 
 
 
 
CLINICAL RESEARCH PROTOCOL 
 
STUDY DRUG: 
OBI-888 
PROTOCOL NUMBER: 
OBI-888-001 
PROTOCOL TITLE: 
A Phase I/II, Open-Label, Dose Escalation 
and Cohort Expansion Study Evaluating the 
Safety, Pharmacokinetics (PK), 
Pharmacodynamics (PD), and Therapeutic 
Activity of OBI-888 in Patients with Locally 
Advanced or Metastatic Solid Tumors 
TRIAL REGISTRATION NUMBERS: 
 
National Clinical Trial Number:  
NCT03573544 
US FDA IND Number: 
136961 
SPONSOR: 
OBI Pharma Inc. 
Ste W1907, 19F, #3, Park St, 
Nankang Software Park, Nangang District, 
Taipei 11503, Taiwan 
VERSION NUMBER: 
Protocol Amendment 4, Version 5.0 
VERSION DATE: 
08-May-2020 
 
 
 
 
 
 
CONFIDENTIAL 
This document contains confidential information of OBI Pharma, Inc. Nothing herein is to be 
disclosed in any way without the prior express written permission of OBI Pharma, Inc. 


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OBI-888 (a humanized anti Globo H mAb) 
 
 
SPONSOR APPROVAL PAGE 
 
 
 
 
 
 
Date: 
 
Tillman Pearce, MD 
Clinical Lead  
Medical Department  
 
 
 
 
 
 
 
PROTOCOL REVISION HISTORY 
 
Version 
Date 
Comment 
1.0 
11 Dec 2017 
Initial version 
2.0 
05 Jan 2018 
a. Updated the eligibility criteria, specifically Inclusion 
Criterion #4 and Exclusion Criterion #15 
b. Updated the DLT definitions 
c. Revised the clinical laboratory assessment frequency 
3.0 
14 Aug 2018 
a. Revised the objectives and endpoints to include RP2D as a 
primary objective and glycan analysis as an exploratory 
endpoint 
b. Updated the eligibility criteria, specifically Inclusion 
Criteria #4, #7, #8; #9, and Exclusion Criteria #1, #4, #9, 
#11, #13, and #14 
c. Updated the DLT definitions 
d. Updated the tumor response evaluation criteria 
e. Revised the PK, ADA, ECG, and radiology assessment 
frequency 
f. Replaced the DMC with an SRC 
4.0 
12 Jun 2019 
a. Updated the study population to enroll patients with cancer 
types with high Globo H expression 
b. Added details regarding the tumor biopsy sample 
requirements and Globo H testing 
c. Revised the enrollment methodology for Part B to use a 
Simon two-stage design 
d. Revised the dosing guidelines and drug product storage 
conditions 


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Version 
Date 
Comment 
5.0 
08 May 2020 a. Removed study assessments, objectives, and endpoints 
pertaining to circulating tumor cells 
b. Clarified the duration of study treatment 
c. Revised pregnancy testing to allow for urine or serum 
testing  
d. Revised the eligibility criteria, specifically Inclusion 
Criteria #9 and #11; and Exclusion Criteria #1 and #5 
e. Updated the OBI-888 drug preparation details  
f. Revised the physical examination, height, weight, vital 
sign, ECOG, ECG, hematology, serum chemistry, 
coagulation, urinalysis, and radiology assessment frequency 
g. Clarified SAE reporting requirements and that disease 
progression should not be reported as an AE or SAE 
 
 


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PROTOCOL OBI-888-001 
 
A PHASE I/II, OPEN-LABEL, DOSE ESCALATION AND COHORT EXPANSION 
STUDY EVALUATING THE SAFETY, PHARMACOKINETICS (PK), 
PHARMACODYNAMICS (PD), AND THERAPEUTIC ACTIVITY OF OBI-888 IN 
PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS. 
 
CONFIDENTIALITY AND INVESTIGATOR STATEMENT 
The information contained in this protocol and all other information relevant to OBI-888-001 
are the confidential and proprietary information of OBI Pharma, Inc., and except as may be 
required by federal, state or local laws or regulation, may not be disclosed to others without 
prior written permission of OBI Pharma, Inc. 
I have read the protocol, including all appendices, and I agree that it contains all of the 
necessary information for me and my staff to conduct this study as described. I will conduct 
this study as outlined herein, in accordance with the in the Declaration of Helsinki, Federal 
Code of Regulations for Good Clinical Practices and International Conference on 
Harmonization guidelines and all applicable regulatory requirements. I will make a 
reasonable effort to complete the study within the time designated. 
I will provide all study personnel under my supervision copies of the protocol and any 
amendments, and access to all information provided by OBI Pharma, Inc. or specified 
designees. I will discuss the material with them to ensure that they are fully informed about 
OBI-888 and the study. 
Investigator’s Signature 
 Date 
 
 
 
 
Name (Printed) 
 Site 


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1 SYNOPSIS 
Title of Study: 
A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study 
Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and 
Therapeutic Activity of OBI-888 in Patients with Locally Advanced or 
Metastatic Solid Tumors. 
Protocol Number: 
OBI-888-001 
Phase of 
Development: 
I/II 
Rationale: 
Globo H is a hexasaccharide glycosphingolipid located endogenously on the 
outer membrane of epithelial cells and was first identified in breast cancer 
cells.  Globo H was found to be overexpressed on the cell surface of several 
epithelial cancers such as breast, pancreatic, ovarian, endometrial, gastric, 
lung, and prostate cancers.  Globo H has been associated with tumor stem 
cells, as a potent inducer of angiogenesis and immune suppressor through 
Notch signaling, rendering it a target for cancer therapy.  
OBI-888 is a human recombinant IgG monoclonal antibody that selectively 
and specifically binds to Globo H.  In summary, the mechanism of action of 
OBI-888 includes: the induction of cancer cell death via complement 
dependent cytotoxicity (CDC), antibody-dependent cell mediated 
cytotoxicity (ADCC), and antibody dependent cellular phagocytosis 
(ADCP); and also it acts by the depletion of Globo-H ceramide (GHCer) 
resulting in anti-angiogenesis and anti-immunosuppression. 
Preclinical studies demonstrated that OBI-888 antibody binds specifically to 
Globo H antigen and antitumor efficacy was noted in preclinical breast, 
pancreatic, colon cancer, and lung cancer tumor xenograft models. 
Study Purpose: 
This is a 2-part study: Part A (Dose Escalation) is designed to establish the 
maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D) 
of OBI-888 as monotherapy. Part B (Cohort Expansion) is intended to 
further characterize the safety and preliminary clinical activity profile of the 
RP2D dose of OBI-888 administered as monotherapy in patients with locally 
advanced or metastatic solid tumors.  
Objectives: 
The primary objectives are:  
• 
To evaluate the safety and tolerability of OBI-888 when 
administered intravenously (IV) to patients with locally advanced or 
metastatic solid tumors.  
• 
To determine the MTD and RP2D of OBI-888 as monotherapy. 
 
The secondary objectives are:  
• 
To evaluate the preliminary clinical activity profile (objective 
response rate [ORR], clinical benefit rate [CBR], duration of 
response [DOR], and progression-free survival [PFS]) with 
OBI-888. 
• 
To evaluate the immunogenicity of OBI-888 (anti-drug antibodies 
[ADAs]). 


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• 
To determine the serum pharmacokinetics (PK) and 
pharmacodynamics (PD) of OBI-888.  
 
Exploratory objectives are:  
• 
To assess ADCC and CDC. 
• 
To identify potential predictive biomarkers.  
• 
To assess the expression of immune markers including immune 
checkpoints, in the tumor tissue samples. 
• 
To assess the expression of Globo H and related tumor-associated 
glycans in the tumor tissue .To perform glycan analysis of OBI-888.  
Study Design: 
This is a Phase I/II, open-label, dose escalation and cohort expansion study 
of OBI-888, a humanized monoclonal antibody (mAb) targeting Globo H in 
patients with locally advanced or metastatic solid tumors. 
Part A – Dose Escalation:   
Three cohorts of escalating dose levels of 5, 10, and 20 mg/kg will be 
assessed using a 3+3 design to identify MTD and RP2D.  Three patients will 
be enrolled at the lowest dose level. If none of the 3 patients experiences a 
dose-limiting toxicity (DLT), the next cohort of 3 patients will be enrolled at 
the next higher dose level. If 1 of 3 patients in the initial dose cohort 
experiences a DLT, that cohort will be expanded to 6 patients.  If only 1 of 
these 6 patients has a DLT, the next cohort of 3 patients will be enrolled at 
the next higher dose level.  If 2 or more patients of the 3-6 patients in a 
cohort experience a DLT, dose escalation will cease, and the lower dose 
level will be designated as the MTD where no more than 1 of 6 patients has 
experienced at DLT.  New patients will be enrolled at the previous lower 
(tolerated) dose level until that cohort has 6 patients.  This lower dose level 
will be considered the MTD if ≤1 in 6 patients has a DLT.  A patient who 
withdraws from the study within the DLT evaluation period for reasons other 
than drug related adverse events (AEs) will be replaced.  
Part A will include a screening period (up to 28 days) prior to the first dose 
of OBI-888, a treatment period, and a follow-up period.  Treatment will 
continue until DLT, progressive disease, unacceptable toxicity, or decision 
by the Investigator or patient to discontinue treatment. 
Patients with locally advanced or metastatic solid tumors will be enrolled in 
Part A.  
Part B – Expansion Cohort:   
Once Part A (Dose Escalation) is completed, Part B will enroll a maximum 
of 150 additional patients with advanced solid tumors with high Globo H 
expression (defined as an H-score cutoff ≥ 100 using a validated 
immunohistochemistry [IHC] assay) across 4 disease specific cohorts and 
1 basket cohort based on a Simon two-stage design. The first stage of Part B, 
will recruit up to 9 patients in each cohort (up to 45 patients in the first stage 
across all cohorts).  If sufficient evidence of activity is observed in the first 
stage, up to 21 additional patients will be enrolled into that cohort (up to 
105 patients in the second stage across all cohorts).   
Part B will be conducted to obtain additional safety data, characterize the 
PK/PD profile of OBI-888, obtain a preliminary assessment of the clinical 


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activity of OBI-888 in Globo H expressing solid tumors, and inform 
subsequent efficacy-finding clinical development. 
No DLTs have been observed at any dose level tested in Part A, and the 
MTD has not been reached.  Therefore, dosing in Part B will be initiated at 
the highest dose tested in Part A (20 mg/kg OBI-888).  
The following 5 cohorts of patients who have high expression of Globo H by 
a qualified laboratory assessment (ie, Globo H H-score ≥ 100 using a 
validated IHC assay) will be enrolled in Part B. 
• 
Cohort 1:  Pancreatic cancer 
• 
Cohort 2:  Esophageal cancer 
• 
Cohort 3:  Gastric cancer 
• 
Cohort 4:  Colorectal cancer 
• 
Cohort 5:  Basket (any solid tumor type other than those included in 
Cohorts 1-4). 
All patients are required to provide a tumor biopsy sample, either unstained 
slides (preferred) or a formalin fixed paraffin embedded (FFPE) tissue block 
at the initiation of screening visit for screening of Globo H overexpression 
and confirmation for eligibility of patients for Part B.  Patients with a 
confirmed and documented Globo H H-score of ≥ 100 will be eligible for the 
study, and will subsequently enter the 28-day screening period to complete 
the remaining screening procedures.  Note that submission of the tumor 
sample for Globo H determination may be performed more than 28 days 
prior to the first dose (after obtaining informed consent), but the other 
screening evaluations must be performed within the 28-day window. 
Part B will include a screening period (up to 28 days) prior to the first dose 
of OBI-888, a treatment period, a follow-up period.  Treatment will 
continue until progressive disease, unacceptable toxicity, or decision by the 
Investigator or patient to discontinue treatment. 
The safety follow-up will be conducted 28-days after the last dose of study 
treatment for both parts. 
Selection of 
Patients – 
Inclusion Criteria: 
Inclusion Criteria:  
Patients must meet all of the following criteria in order to be included in the 
study: 
1. Male or female patients, 18 years of age or older at the time of 
consent. 
2. Provide written informed consent prior to performing any 
study-related procedure. 
3. Histologically or cytologically confirmed patients with advanced or 
metastatic solid tumors for both Dose Escalation and Expansion. 
4. Patients must have been treated with established standard-of-care 
therapy, or physicians have determined that such established therapy 
is not sufficiently efficacious, or patients have declined to receive 
standard-of-care therapy.  
5. Measurable disease (i.e., at least one measurable lesion per Response 
Evaluation Criteria in Solid Tumors (RECIST), version 1.1.  


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6. Eastern Cooperative Oncology Group (ECOG) performance status of 
0 or 1.  
7. Adequate organ function defined as: 
o Hepatic: 
 
Serum alanine aminotransferase (ALT) ≤3 × upper 
limit of normal (ULN), ≤5 × ULN in the presence of 
liver metastases 
 
Serum aspartate aminotransferase (AST) ≤3 × ULN, 
≤5 × ULN in presence of liver metastases 
 
Serum bilirubin ≤1.5 × ULN 
o Renal: 
 
Creatinine clearance >30 mL/minute using 
Cockcroft Gault equation 
o Hematologic: 
 
Absolute neutrophil count ≥1000/µL 
 
Platelets ≥75,000/µL 
 
Hemoglobin ≥8 g/dL 
8. Patient is willing and able to comply with all protocol-required 
assessments, visits, and procedures, including pretreatment tumor 
biopsy.  Archival tumor biopsies (slides or FFPE tissue block) are 
acceptable at baseline.  
9. Females of childbearing potential must have a negative urine or 
serum pregnancy test prior to starting study therapy, and agree to use 
a reliable form of contraceptive during the study treatment period 
and for at least 120 days following the last dose of study drug.  
Subject not of childbearing potential (i.e., permanently sterilized, 
postmenopausal) can be included in study.  Postmenopausal is 
defined as 12 months with no menses without an alternative medical 
cause. 
Male patients must agree to use an adequate method of contraception 
during the study treatment period and for at least 120 days following 
the last dose of study drug. 
10. Cannot be breast feeding. 
11. Patients in Part B (Cohort Expansion) must have a documented 
Globo H H-score of at least 100 from a qualified laboratory IHC 
assay in one of the following tumor types to be enrolled in the 
respective cohort: 
o Cohort 1:  Pancreatic cancer 
o Cohort 2:  Esophageal cancer 
o Cohort 3:  Gastric cancer 
o Cohort 4:  Colorectal cancer 
o Cohort 5:  Basket (any solid tumor type other than those 
included in Cohorts 1 through 4) 


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Selection of 
Patients – 
Exclusion Criteria: 
Exclusion Criteria:  
Patients meeting any of the following criteria are ineligible to participate in 
this study: 
1. Less than 3 weeks, from prior cytotoxic chemotherapy or radiation 
therapy; and less than 5 half-lives or 3weeks from biological 
therapies, whichever is shorter, prior to the first dose of OBI-888. 
2. Has undergone a major surgical procedure (as defined by the 
Investigator) or significant traumatic injury within 28 days prior to 
the first dose of OBI-888. 
3. Presence of an active autoimmune or inflammatory disease requiring 
systemic treatment within the past 2 months or a documented history 
of clinically severe autoimmune disease that requires systemic 
steroids or other immunosuppressive medications.  Local steroid 
injections, intermittent use of topical, inhaled, ophthalmologic, 
intra-articular, topical, or intranasal corticosteroids, or systemic 
corticosteroids at physiologic doses not to exceed 10 mg/day of 
prednisone or equivalent would not be excluded from the study.  
4. Presence of primary immunodeficiency or receiving systemic 
steroids of >10 mg/day of prednisone or equivalent or other 
immunosuppressive agents within 14 days prior to the first dose of 
OBI-888.  
5. Has active bacterial, viral, fungal, or mycobacterial infection 
requiring systemic therapy, including known infection with human 
immunodeficiency virus (HIV) or active infection with hepatitis B 
virus or hepatitis C virus.  Patients with HIV infection are eligible if 
CD4+ T-cell counts are ≥350 cells/µL; patients on antiretroviral 
therapy should be on an established dose for at least 4 weeks and 
have an HIV viral load less than 400 copies/mL prior to enrollment. 
6. Patients with a history of solid organ transplant. 
7. Unresolved toxicities from prior anticancer therapy, defined as 
having not resolved to Grade 0 or 1 (using National Cancer Institute 
Common Terminology Criteria for Adverse Events [NCI CTCAE] 
version 4.03), except for alopecia and laboratory values listed in the 
inclusion criteria. 
8. Receipt of any prior therapy targeting Globo H. 
9. Known hypersensitivity to OBI-888 or its excipients. 
10. Has known untreated central nervous system metastases. Patients 
with treated brain metastases are eligible if there is no evidence of 
progression for at least 4 weeks after central nervous system-directed 
treatment, as ascertained by clinical examination and brain imaging 
(magnetic resonance imaging [MRI] or computed tomography [CT]) 
during the screening period.  
11. Any medical co-morbidity or psychiatric illness that is 
life-threatening or, in the opinion of the Investigator, renders the 
patient unsuitable for participation in a clinical trial due to possible 


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noncompliance, would place the patient at an unacceptable risk, 
and/or potential to affect interpretation of results of the study. 
12. Is receiving any concurrent prohibited medication as listed in 
Section 8.6.3. 
Planned Sample 
Size: 
Up to 18 patients will be enrolled in the 3+3 dose escalation phase (Part A). 
The cohort expansion phase (Part B) will enroll up to 150 total patients 
based on a Simon two-stage design.  The first stage will recruit up to 
9 patients in each cohort.  If at least 1 objective response is observed within 
the first 6 cycles of therapy, a second stage recruitment will occur with up to 
21 additional patients enrolled into that cohort, for a total of up to 30 patients 
per cohort.   
If at least 4 objective responses are observed within the first 6 cycles of 
therapy in 30 patients, then OBI-888 will be considered worthy of further 
evaluation in that indication.  This design is based on a level of low interest 
for a treatment with an ORR of 5% versus a level of high interest for a 
treatment with an ORR of 25%.  The sample size is based on a one-sided 
alpha of 0.05 and 90% power.  The two-stage design limits the number of 
patients treated using a treatment with low levels of activity. 
Investigational 
Therapy: 
 
Dose/ Route/ 
Regimen 
OBI-888 (a humanized anti-Globo H mAb). 
OBI-888 drug product (in final concentration 30 mg/mL) will be supplied by 
OBI Pharma Inc. 
OBI-888 will be administered as a 90-minute IV infusion on Days 1, 8, 15, 
and 22 of each 28-day cycle. The infusion duration may be reduced, at the 
Investigator’s discretion, to 30-60 minutes starting with Cycle 3 if the 
infusions in the first two cycles are well tolerated. 
• 
For Part A (Dose Escalation), OBI-888 will be given at dose levels 
of 5, 10, and 20 mg/kg until the MTD is determined.  
• 
For Part B (Cohort Expansion), patients will be treated with 
20 mg/kg OBI-888 since no DLTs were observed at any of the dose 
levels tested in Part A, and the MTD was not reached.   
Reference 
Therapy: 
None 
Treatment 
Duration: 
Patients will be treated during the treatment period until progressive disease, 
unacceptable toxicity, or decision by the Investigator or patient to 
discontinue treatment. 
Criteria for 
Evaluation: 
Safety: 
Safety assessments include incidence and severity of AEs and serious AEs 
(SAEs), clinical laboratory tests (hematology, serum chemistry, coagulation, 
and urinalysis), vital sign measurements, electrocardiograms (ECGs), and 
physical examination.  Safety assessments are performed at screening and 
throughout the study.  
DLTs: 
A DLT is defined as the occurrence of any of the following events, within 
the first cycle of treatment, that are considered to be at least possibly related 


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to OBI-888. All AEs unless they have been determined to be not related to 
study drug will be taken into consideration in determining DLTs. NCI-
CTCAE version 4.03 will be the basis for the descriptive terminology and 
grading of AEs. 
DLTs are defined as: 
• 
Grade 4 neutropenia 
• 
≥Grade 3 febrile neutropenia with or without infection. 
• 
Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with 
bleeding 
• 
≥Grade 3 nausea and vomiting or diarrhea for more than 72 hours 
despite optimal supportive care 
• 
Any other ≥Grade 3 non-hematological AE that does not resolve 
before the next infusion 
The DLT evaluation period is the first cycle; 28 days from the start of study 
treatment.  
Immunogenicity: 
Immunogenicity assessments will be performed at Cycle 1 Day 1 and 
throughout the trial.  
PK:  
Blood samples will be collected for evaluation of serum OBI-888 
concentration, to assess the accumulation of OBI-888, and to assess the 
attainment of steady state. 
The timing of the PK samples may be adjusted upon review of accumulating 
data. 
PK parameters will be calculated using a non-compartmental method from 
the PK samples collected on Dose 1 and will include but will not be limited 
to maximum serum concentration (Cmax), total exposure (AUC), elimination 
half-life (t1/2), clearance (Cl), time to reach maximum concentration (Tmax) 
and volume of distribution (Vd).  To assess the attainment of steady state, 
trough (Cmin) concentrations and peak concentrations (end of infusion) of 
each dose would be obtained directly from analytical data.   
Pharmacometric methods may also be applied to further investigate OBI-888 
exposure (e.g., accumulation of OBI-888, presence of dose- or 
time-dependent OBI-888 PK behavior, verification of influential factors on 
OBI-888 PK).  
Preliminary Clinical Activity Profile:  
Tumor response will be evaluated by the Investigator using RECIST 
version 1.1.  Tumor status assessment will be performed pretreatment (up to 
28 days prior to dosing). During the study tumor response will be assessed 
after every second cycle (every 8 weeks) for the first 6 months, then every 
12 weeks thereafter.    


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Study Endpoints: 
Primary endpoints:   
• 
DLTs with OBI-888 
• 
AEs/SAEs and laboratory abnormalities as graded by NCI CTCAE 
version 4.03 
• 
MTD and RP2D of OBI-888 
Secondary endpoints:   
• 
Percentage of patients with ORR, CBR, DOR and PFS according to 
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 
1.1)  
• 
Percentage of patients with anti-OBI-888 antibodies (ADAs) in 
blood 
• 
PK and PD parameters of OBI-888  
Exploratory endpoints: 
• 
Globo H and related glycan expression in tumor tissue by IHC 
• 
ADCC and CDC 
• 
Identify potential predictive markers by IHC or molecular analysis 
• 
Tumor infiltrating Lymphocytes (TILs), including natural killer 
(NK) cells, and programmed death – ligand 1 (PD-L1) expression in 
tumor tissue samples by IHC 
• 
Killer cell immunoglobulin-like receptor (KIR), human leukocyte 
antigen (HLA), and Fc receptor gamma genotype 
• 
Glycan analysis of OBI-888 
Statistical Methods 
and Planned 
Analyses: 
Analyses will be conducted by dose level in the dose escalation phase and by 
cohort in the expansion phase.  Descriptive summaries for categorical 
variables will include counts and percentages.  Descriptive summaries for 
continuous variables will include means, medians, standard deviations, 
minimum and maximum values.  Descriptive summaries of time to event 
data will include medians and confidence intervals.  Graphical summaries of 
the data may be presented.  All data will be listed for all patients.   
Further details of the analysis, including the handling of missing data, 
transformations, other data handling procedures, and analytical methodology 
will be provided in the Statistical Analysis Plan (SAP).  Additional 
exploratory analyses of the data will be conducted as deemed appropriate. 
All analyses of safety and preliminary clinical activity profile will be 
performed on all patients who were enrolled and received at least 1 dose of 
study drug. 
Safety Analyses 
AEs will be coded according to Medical Dictionary for Regulatory Activities 
(MedDRA) version 19.0 or higher and assessed for severity using CTCAE 
version 4.03.  AEs will be summarized by system organ class and preferred 
term and presented in decreasing order of incidence.  DLTs will also be 
summarized by dose and cohort. 
Vital signs, ECG data, hematology, serum chemistry, coagulation, and 
urinalysis parameters from baseline and during study will be examined.  
Treatment-emergent changes in key laboratory parameters will be identified.  


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Laboratory data will be summarized for each time point that specimens are 
collected.  Changes from baseline for laboratory values may also be explored 
as specified in the SAP. 
PK Analyses 
PK parameters will be calculated using a non-compartmental method from 
the PK samples collected on Dose 1 and will include but is not limited to 
Cmax, AUC, t1/2, Cl, Tmax and Vd.  To assess the attainment of steady state, 
trough (Cmin) concentrations and peak concentrations (end of infusion) of 
each dose would be obtained directly from analytical data.  Summary 
statistics will be tabulated for the PK parameters of OBI-888 on Dose 1.  
Geometric means and coefficients of variation will be presented for Cmax, 
AUC, t1/2, Cl, and Vd.  Median, minimum, and maximum will be presented 
for Tmax.  
To describe the dependency on dose, scatter plots of Cmax and AUC versus 
dose will be provided.  Summary statistics will be tabulated for the trough 
(Cmin) concentration and peak concentrations (end of infusion) by dose and 
study day.  To assess the attainment of steady state, geometric mean Cmin 
values will be plotted versus study day by dose.  
Pharmacometric methods may also be applied to further investigate OBI-888 
exposure (e.g., accumulation of OBI-888, presence of dose- or 
time-dependent OBI-888 PK behavior, and verification of influential factors 
on OBI-888 PK). 
Preliminary Clinical Activity Profile Analyses 
ORR will be summarized as the percentage of patients with confirmed 
partial response (PR) or complete response (CR) according to RECIST 
version 1.1.  CBR will be summarized as the percentage of patients with 
confirmed CR, PR, or stable disease (SD).  DOR, defined as time from the 
date of reported confirmed PR or CR to the date of progression will be 
summarized descriptively using summary statistics. Additionally, a listing of 
DOR for those patients experiencing response will be provided. PFS is 
defined as the time from first dose of study drug until radiographically 
determined disease progression or death due to any cause, whichever event 
occurs first.  Patients who are still alive or who have no progressive disease 
reported at analysis will be censored at their last evaluable tumor assessment.  
Time to progression, death, and/or censoring will be reported for all patients.  
Kaplan-Meier estimates and 95% confidence intervals will be presented for 
time-to-event endpoints such as PFS if sufficient numbers of events to 
calculate meaningful statistics are observed. 


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2 
Table of Contents 
1 
Synopsis ............................................................................................................................... 5 
2 
Table of Contents .............................................................................................................. 14 
2.1 
In-Text Tables ........................................................................................................ 17 
2.2 
In-Text Figures ...................................................................................................... 17 
3 
List of Abbreviations ......................................................................................................... 18 
4 
Introduction ....................................................................................................................... 20 
4.1 
Background on OBI-888 ....................................................................................... 20 
4.2 
Nonclinical Studies ................................................................................................ 21 
4.2.1 
Anti-tumor Effect of OBI-888 in a MCF-7 Xenograft Model .............. 21 
4.2.2 
A 7-day Single Dose Toxicity Study in Sprague-Dawley Rats ............ 21 
4.2.3 
A 28-day Repeat Dose Toxicity Study in Sprague Dawley Rats 
Followed by a 14-day Recovery Phase ................................................. 22 
4.2.4 
A 28-day Repeat Dose Toxicity Study in Cynomolgus Monkeys 
Followed by a 14-day Recovery Phase ................................................. 23 
4.3 
Clinical Studies ...................................................................................................... 24 
4.3.1 
Results from OBI-888-001 .................................................................... 24 
4.3.2 
Globo H H-Score in Various Tumor Tissues ........................................ 24 
4.4 
Clinical Risks/Benefits of OBI-888 ....................................................................... 25 
4.5 
Rationale ................................................................................................................ 25 
5 
Study Objectives and Endpoints........................................................................................ 27 
5.1 
Study Objectives .................................................................................................... 27 
5.1.1 
Primary Objectives ................................................................................ 27 
5.1.2 
Secondary Objectives ............................................................................ 27 
5.1.3 
Exploratory Objectives ......................................................................... 27 
5.2 
Study Endpoints ..................................................................................................... 27 
5.2.1 
Primary Endpoints ................................................................................. 27 
5.2.2 
Secondary Endpoints ............................................................................. 27 
5.2.3 
Exploratory Endpoints .......................................................................... 27 
6 
Investigational Plan ........................................................................................................... 28 
6.1 
Description of Overall Study Design and Plan ...................................................... 28 
6.1.1 
Part A - Dose Escalation ....................................................................... 28 
6.1.2 
Part B - Cohort Expansion .................................................................... 28 
6.1.3 
Duration of Study .................................................................................. 29 
6.2 
Definition of Dose-Limiting Toxicities ................................................................. 29 
6.3 
Discussion of Study Design ................................................................................... 30 
7 
Selection and Withdrawal of Patients ............................................................................... 30 
7.1 
Inclusion and Exclusion Criteria ........................................................................... 30 


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7.1.1 
Inclusion Criteria ................................................................................... 30 
7.1.2 
Exclusion Criteria ................................................................................. 31 
7.2 
Treatment Discontinuation and Withdrawal of Subjects ....................................... 32 
7.3 
Follow-Up for Drug Discontinuation/Subject Withdrawal from Study ................ 33 
8 
Treatments ......................................................................................................................... 33 
8.1 
Details of Study Treatment .................................................................................... 33 
8.1.1 
Packaging and Labeling ........................................................................ 33 
8.1.2 
Storage .................................................................................................. 34 
8.2 
Dosage Schedule .................................................................................................... 34 
8.2.1 
OBI-888 Doses ...................................................................................... 34 
8.2.2 
Regimen ................................................................................................ 34 
8.2.3 
Duration of Infusion .............................................................................. 34 
8.3 
Dose Modifications and Toxicity Management .................................................... 34 
8.3.1 
Infusion Reactions ................................................................................. 35 
8.4 
Study Treatment Assignment ................................................................................ 36 
8.5 
Treatment Accountability and Compliance ........................................................... 36 
8.6 
Prior and Concomitant Illnesses and Medications ................................................ 36 
8.6.1 
Prior and Concomitant Illnesses ........................................................... 36 
8.6.2 
Prior and Concomitant Medications ..................................................... 36 
8.6.3 
Prohibited Medications ......................................................................... 37 
9 
Study Procedures ............................................................................................................... 37 
9.1 
Subject Informed Consent ..................................................................................... 37 
9.2 
Procedures by Study Period ................................................................................... 37 
10 Clinical Activity Profile Assessments ............................................................................... 44 
11 Pharmacokinetics ............................................................................................................... 44 
11.1 
Pharmacokinetic Sampling .................................................................................... 44 
11.2 
Pharmacokinetic Analytical Methodology ............................................................ 44 
12 Safety Assessments ........................................................................................................... 44 
12.1 
Vital Signs ............................................................................................................. 44 
12.2 
Physical Examination ............................................................................................ 45 
12.3 
Electrocardiogram ................................................................................................. 45 
12.4 
Laboratory Assessments ........................................................................................ 45 
12.5 
Adverse Events ...................................................................................................... 47 
12.5.1 
Adverse Events ..................................................................................... 47 
12.5.2 
Serious Adverse Events ........................................................................ 48 
12.5.3 
Serious Adverse Event Reporting ......................................................... 49 
12.5.4 
Pregnancy .............................................................................................. 49 
12.5.5 
Overdose ............................................................................................... 50 


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12.6 
ECOG Performance Status .................................................................................... 50 
12.7 
Immunogenicity ..................................................................................................... 50 
13 Exploratory Analyses ........................................................................................................ 51 
13.1 
Blood Samples ....................................................................................................... 51 
13.2 
Tumor Tissue Samples .......................................................................................... 51 
13.3 
Glycan Analysis of OBI-888 ................................................................................. 51 
14 Statistical Analysis ............................................................................................................ 52 
14.1 
Determination of Sample Size ............................................................................... 52 
14.2 
Analysis of Populations ......................................................................................... 52 
14.3 
Preliminary Clinical Activity Profile Analysis ...................................................... 52 
14.4 
Pharmacokinetic Analysis ..................................................................................... 53 
14.5 
Safety Analysis ...................................................................................................... 53 
14.6 
Safety Review Committee (SRC) .......................................................................... 54 
14.7 
Interim Analysis .................................................................................................... 54 
15 Study Management ............................................................................................................ 54 
15.1 
Approval and Consent ........................................................................................... 54 
15.1.1 
Regulatory Guidelines ........................................................................... 54 
15.1.2 
Institutional Review Board/Independent Ethics Committee ................. 54 
15.1.3 
Informed Consent .................................................................................. 54 
15.2 
Data Handling ........................................................................................................ 55 
15.3 
Source Documents ................................................................................................. 55 
15.4 
Record Retention ................................................................................................... 55 
15.5 
Monitoring ............................................................................................................. 55 
15.6 
Quality Control and Quality Assurance ................................................................. 56 
15.7 
Protocol Amendment and Protocol Deviation ....................................................... 56 
15.7.1 
Protocol Amendment ............................................................................ 56 
15.7.2 
Protocol Deviations ............................................................................... 56 
15.8 
Ethical Considerations ........................................................................................... 56 
15.9 
Financing and Insurance ........................................................................................ 56 
15.10 Publication Policy and Disclosure of Data ............................................................ 57 
16 References ......................................................................................................................... 58 
17 Appendices ........................................................................................................................ 59 
17.1 
Appendix 1 Drug Preparation Instruction for OBI-888 ......................................... 59 
 


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2.1 In-Text Tables 
Table 4-1 
Prevalence of Globo H Cut-Off in Different Cancer Types ................. 25 
Table 8-1 
OBI-888 Dose Modifications for Toxicity ............................................ 34 
Table 8-2 
Therapeutic Antiemetic and Anti-Diarrheal Recommendations ........... 35 
Table 9-1 
Schedule of Assessments ...................................................................... 38 
Table 9-2 
Part A – Pharmacokinetic, ADA, Biomarker, and Glycan Sampling 
Schedule ................................................................................................ 40 
Table 9-3 
Part B – Pharmacokinetic, ADA, and Biomarker Sampling 
Schedule ................................................................................................ 42 
Table 12-1 
Laboratory Assessments ....................................................................... 46 
Table 12-2 
Classification of Adverse Events by Intensity (NCI CTCAE Grade) ... 47 
Table 12-3 
Classification of Adverse Events by Relationship to Study Drug ........ 48 
Table 12-4 
ECOG Performance Status .................................................................... 50 
2.2 In-Text Figures 
Figure 4-1 
Globo H Immunohistochemistry H-Score of Various Tumor 
Tissues ................................................................................................... 25 
 


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3 
List of Abbreviations 
Abbreviation 
Definition 
ADAs 
anti-drug antibodies 
ADCC 
antibody-dependent cell mediated cytotoxicity 
ADCP 
antibody dependent cellular phagocytosis 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT (SGPT) 
alanine aminotransferase (serum glutamic pyruvic transaminase) 
aPTT 
activated partial thromboplastin time 
AST (SGOT) 
aspartate aminotransferase (serum glutamic oxaloacetic transaminase) 
AUC 
total exposure 
BUN 
blood urea nitrogen 
C 
cycle 
CBR 
clinical benefit rate 
CDC 
complement dependent cytotoxicity 
Cl 
clearance 
Cmax 
maximum serum concentration 
CR 
complete response 
CFR 
Code of Federal Regulations 
Cmin 
trough 
CRO 
Contract Research Organization 
CT 
computed tomography 
DCF 
Data Clarification Form 
DLT 
dose-limiting toxicity 
DOR 
duration of response 
DP 
drug product 
eCRF 
electronic case report form 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
EDC 
electronic data capture 
FFPE 
formalin fixed paraffin embedded 
GCP 
Good Clinical Practice 
GHCer 
Globo-H ceramide 
GMP 
Good Manufacturing Practice 
HIPAA 
Health Insurance Portability Accountability Act 
HIV 
human immunodeficiency virus 
HLA 
human leukocyte antigen 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IgG 
immunoglobulin G 
IgM 
immunoglobulin M 
IHC 
immunohistochemistry 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
IV 
intravenous(ly) 
KIR 
killer cell immunoglobulin-like receptor 
LDH 
lactate dehydrogenase 
mAb 
monoclonal antibody 
MedDRA 
Medical Dictionary for Regulatory Activities 


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Abbreviation 
Definition 
MRI 
magnetic resonance imaging 
MTD 
maximum tolerated dose 
NCI CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
NK 
natural killer 
NOAEL 
no-observed-adverse-effect level 
ORR 
objective response rate 
OS 
overall survival 
PD 
pharmacodynamic 
PD-LI 
programmed death – ligand 1 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PR 
partial response 
PT 
prothrombin time 
Q8wk 
every 8 weeks 
Q12wk 
every 12 weeks 
RBC 
red blood cell 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RP2D 
recommended phase II dose 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SC 
subcutaneously 
SD 
stable disease  
SRC 
safety review committee 
T1/2 
half-life 
TACA 
tumor-associated carbohydrate antigens 
TEAE 
treatment-emergent adverse event 
TGI 
tumor growth inhibition 
TIL 
tumor infiltrating lymphocytes 
Tmax 
time to reach maximum concentration 
ULN 
upper limit of normal 
Vd 
volume of distribution 
WHO 
World Health Organization 


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4 
Introduction 
4.1 Background on OBI-888 
Globo H is a neutral hexasaccharide (Fucα1→2Ga1β1→3GalNAcβ1→3Ga1α1→4Ga1β1→ 
4G1cβ1) glycosphingolipid, was originally isolated from the human breast cancer cell line 
MCF-7 (Menard, et al., 1983; Bremer, et al. 1984).  Its overexpression has been seen on a variety 
of epithelial cell tumors such as colon, ovarian, gastric, pancreatic, endometrial, lung, prostate, 
and breast cancers with the use of monoclonal antibodies (mAbs), MBrl (immunoglobulin M 
[lgM]) (Menard, et al., 1983; Bremer, et al. 1984; Canevari, et al., 1983) and VK-9 
(immunoglobulin G 3 [IgG3]) (Ragupathi, et al., 1999).   
In normal tissue, Globo H is weakly expressed at the apical epithelial cells at lumen border, a 
site which appears to be inaccessible to the immune system.  Globo H ceramide shed from 
tumor cells - acting as an immune checkpoint molecule to facilitate the escape of cancer cells 
from immune surveillance - inhibits the activation of immune cells (Tsai, et al., 2013). 
Incorporation of Globo H ceramide by endothelial cells results in enhanced angiogenic activity 
to promote tumor growth (Cheng, et al., 2014).  
Due to its property, Globo H may serve as a promising target for immunotherapy for epithelial 
cancers.  Given the finding of increased expression across a variety of cancers, Globo H can be 
considered an ideal target and Globo H-based anticancer therapeutics can be broadly useful 
treating number of oncology indications.  OBI-888, a recombinant human immunoglobulin G 
(IgG) mAb, selectively binds to Globo H, a tumor associated carbohydrate antigen (TACA).  
OBI-888 is highly specific to Globo H antigen.  Antibody-dependent cell mediated cytotoxicity 
(ADCC) is one of the mechanisms for therapeutic antibodies to kill target cancer cells.  The 
action is initiated by ligation of FcyRIIIa on effector cells, predominantly natural killer cells, to 
antibodies bound to cell-associated antigens.  Multiple cross-linking of the two cell types leads 
to pathway activation of ADCC (Richards, et al., 2008).  
OBI-888 has also been shown to suppress the Globo-H ceramide (GHCer) induced T cell 
inactivation by Jurkat/NFAT Re Luc reporter bioassay activated by anti-CD3/CD28 antibodies.  
Depletion of GHCer by OBI-888 serves as a plausible route in overcoming the 
immunosuppression induced by the cancer cells. 
Previously, Globo H-based cancer vaccines have been evaluated in clinical trials for the past 
several years.  For example, the cancer vaccine KLH-Globo H conjugate (OBI-822/OBI-821, 
also known as OPT-822/OPT-821) is currently in Phase II/III clinical trials for the treatment of 
metastatic breast cancer (NCT01516307).  It was reported that progression-free survival (PFS) 
and interim overall survival (OS) were significantly improved in those patients who developed 
a Globo H specific IgG response to the vaccine.  However, several challenges have been 
recognized, including inconsistency in eliciting T cell-mediated immunity in cancer patients, 
mandatory usage of an adjuvant since TACAs in general are usually poorly immunogenic, 
emergence of immunotolerance to KLH and difficulties in the control of conjugate quality 
(Zhou, et al., 2015). In order to achieve the desired immunological response, alternate carriers 
of the carbohydrate antigens are being studied. In addition to the vaccine strategy, 
Globo H-targeted therapy targeting the epitope using mAb can be a reasonable alternative.  


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4.2 Nonclinical Studies 
4.2.1 Anti-tumor Effect of OBI-888 in a MCF-7 Xenograft Model 
In a tumor xenograft model of human breast adenocarcinoma, viable MCF-7 (ATCC HTB-22) 
cells were subcutaneously (SC) implanted (2.0 x 107 cells in 1:1 matrigel/media mixture at 
0.2 mL/mouse) into female athymic nude mice.  Supplemental injections of estradiol 
cyclopentyl propionate (100 µg/mouse) were administered SC between the scapulae twice 
weekly beginning one week prior to cell implantation, and continuing through to study 
completion.  Intravenous administration of OBI-888 was initiated one day after tumor cell 
implantation (denoted as Day 1).  Tumor implanted mice were divided into four treatment 
groups, each group containing eight animals.  Intravenous injections of the vehicle (25 mM 
sodium citrate, pH 6.5) at 10 mL/kg and OBI-888 at 1, 3, and 10 mg/kg were administered twice 
weekly for 6 weeks.  The tumor size was monitored and recorded for 42 days.  Mortality, body 
weight, and signs of overt animal toxicity were recorded twice weekly for 42 days.  Tumor 
growth inhibition (TGI) was calculated as T/C (treatment/control) x 100% and TGI 
(1-T/C) x 100%.  T/C value <42% was considered significant antitumor activity.  Two-way 
ANOVA followed by Bonferroni test was applied to ascertain the statistically significant 
difference compared to respective vehicle. 
Biweekly intravenous administration of OBI-888 at 10 mg/kg was associated with significant 
antitumor activity (T/C value <42%, and p <0.05) on Day 42, and moderate, but statistically 
significant (p <0.05), antitumor activity from Day 19 to Day 40 compared to vehicle control 
group.  OBI-888 at 3 mg/kg intravenous biweekly administration was associated with moderate, 
but statistically significant (p <0.05), antitumor activity from Day 22 to Day 42 compared to 
vehicle control group.  OBI-888 at 1 mg/kg intravenous biweekly showed slight TGI compared 
to vehicle control group during the study period.  On Day 42, TGI was 27%, 50% and 85% for 
OBI-888 at 1, 3, and 10 mg/kg by intravenous administration twice weekly, respectively. 
All test doses of OBI-888 were well-tolerated in animals, and were not associated with 
significant changes in body weight compared to the vehicle groups.  No overt toxicities were 
observed during the study period. 
4.2.2 A 7-day Single Dose Toxicity Study in Sprague-Dawley Rats 
A single bolus of OBI-888 administered intravenous at 10, 60, and 300 mg/kg was assessed for 
its possible adverse and toxic effects in both male and female Sprague-Dawley rats over a 7-day 
experimental period.  
OBI-888 was associated with moderate flushed skin within 60 minutes after treatment (60 and 
300 mg/kg: 66%/ 44% and 100%/ 100% in male/ female rats, respectively), but normal skin 
color returned in a short period of time.  No other significant clinical observations were 
observed during cage-side inspections and all treated animals survived over the 7-day study 
period.  Moreover, body weight gains, as well as food and water consumption, were not affected 
by administration of OBI-888. 
Compared to vehicle control, serum calcium was slightly elevated by 10 and 60 mg/kg 
OBI-888, and serum potassium and chloride were mildly increased by 60 mg/kg OBI-888 in 
male rats.  These parameters were unchanged relative to vehicle control in female rats.  Urinary 
pH, protein, urobilinogen, nitrate, leukocyte, glucose, bilirubin, ketone, specific gravity and red 
blood cell count (RBC) were not altered following OBI-888 administrations at terminal.  The 
clotting times and the blood cell populations were not affected by OBI-888 injections on Day 7. 


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The animals of OBI-888 300 mg/kg treated groups were sacrificed and the organs were checked 
externally and internally and harvested for histopathological examination. Some mottled 
surfaces were observed in kidneys in both 300 mg/kg treated male and female rats with 
incidences of 100% and 33%, respectively.  Non-specific lesions such as focal, tubular cysts, 
infarct and granulation in the kidney and an endometrial stromal polyp in the uterus were 
observed in OBI-888 300 mg/kg in histological data that might be related to spontaneous 
incidence in rats.  In addition, focal inflammatory cell infiltration in the lung and diffuse acinar 
cell atrophy in the salivary gland were found in some OBI-888 300 mg/kg treated rats. 
4.2.3 A 28-day Repeat Dose Toxicity Study in Sprague Dawley Rats Followed by 
a 14-day Recovery Phase 
OBI-888 administered via intravenous bolus injection at dose levels of 0, 20, 60, and 200 mg/kg 
once weekly for a total of 4 doses (Day 1, 8, 15, and 22) was assessed for its possible adverse 
and toxic effects in both male and female Sprague Dawley rats over a 28-day period.  The 
potential reversibility of any findings following a 14-day recovery period was also evaluated.  
The first day of dosing was designated as Day 1. 
There were no OBI-888-related changes in clinical signs, body weights, food consumption, 
ophthalmic examinations, and functional observational battery parameters.  All animals dosed 
with control or OBI-888 survived over the 28-day period. 
There were no definitive OBI-888-related changes in hematology parameters at any dose.  On 
Day 28, there were statistically significant increases in mean reticulocytes in males at 
200 mg/kg (1.40 × control mean).  Such increases were likely driven by the unusually high 
reticulocytes in one male rat at 200 mg/kg.  This animal also had moderately decreased platelets 
on Day 28 (0.14 × control mean).  Such high reticulocyte counts were correlated to increased 
hematopoiesis in histopathology assessments.  These increases were considered of uncertain 
relationship to OBI-888 due to the single incidence of these changes and presence of 
microscopic correlates.  At 200 mg/kg/dose, one treated male rat had increased eosinophils 
(2.11 × of pretreatment).  Similar increases were observed in control animals; therefore, these 
changes were considered likely unrelated to OBI-888.  On Day 28, there were statistically 
significant increases in mean neutrophils in females at 200 mg/kg (1.56 × control mean).  The 
increases were likely due to generally lower mean neutrophils in the control females compared 
to the 200 mg/kg females (including at the pre-study time point, Day -5), and was unrelated to 
OBI-888.  There were no definite OBI-888-related changes in clinical chemistry, coagulation, 
and urinalysis parameters at any dose. 
The animals of all 4 OBI-888 treated groups (0, 20, 60, and 200 mg/kg) were sacrificed and the 
organs were checked externally and internally and harvested for histopathological examination.  
At terminal euthanasia, OBI-888-related higher mean absolute and/or relative organ weights 
were observed in the spleen of animals given 200 mg/kg/dose and in the liver of males given 
200 mg/kg/dose; no definitive microscopic correlates were observed.  No definitive OBI-888-
related macroscopic or microscopic findings were observed.  At recovery euthanasia, no 
OBI-888-related organ weight differences, macroscopic findings, or microscopic findings were 
observed. 
In conclusion, administration of OBI-888 by intravenous bolus injection once weekly for 
28 days was well tolerated in Sprague Dawley rats at levels of 200 mg/kg/dose.  Based on these 
results, the no-observed-adverse-effect level (NOAEL) was considered to be 200 mg/kg/day. 


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4.2.4 A 28-day Repeat Dose Toxicity Study in Cynomolgus Monkeys Followed 
by a 14-day Recovery Phase 
OBI-888 administered via intravenous (slow bolus) injection at dose levels of 0, 20, 60, and 
200 mg/kg once weekly for a total of 4 doses (Day 1, 8, 15, and 22) was assessed for its possible 
adverse and toxic effects in both male and female cynomolgus monkeys over a 28-day period.  
The potential reversibility of any findings following a 14-day recovery period and its 
toxicokinetic characteristics were also evaluated.  The first day of dosing was designated as 
Day-1.  
No OBI-888-related clinical observations occurred during this study.  All clinical observations 
that occurred were considered unrelated to OBI-888 because they were transient and did not 
persist, were considered to be related to study procedures, or were incidental findings 
commonly seen in laboratory-housed cynomolgus monkeys under similar study conditions.  In 
addition, body weights, as well as qualitative food consumption, were not affected by 
administration of OBI-888.  All animals dosed with control or OBI-888 survived until scheduled 
necropsy. 
No OBI-888-related ocular effects occurred during this study. No OBI-888-related 
abnormalities in rhythm or waveform morphology were found at any dose level based on 
comparison of pre-dose and post-dose electrocardiographic recordings.  No OBI-888-related 
changes in electrocardiography parameters and all the electrocardiograms (ECGs) evaluated in 
this study were qualitatively considered normal. 
There were no definitive OBI-888-related changes in hematology parameters at any dose.  On 
Day 28, four animals at 200 mg/kg had decreased neutrophil counts that were below the lowest 
control or pre-study values.  These changes were considered to be of uncertain relationship to 
OBI-888 given the minimal magnitude of decrease below the lowest control value and the lack 
of microscopic correlates.  OBI-888-related changes in coagulation parameters were limited to 
minimally increased fibrinogen in two 200 mg/kg treated female animals on Day 28.  These 
changes were associated with mildly increased globulins and decreased albumin, suggestive of 
an acute phase response in these animals and were considered non-adverse.  OBI-888-related 
changes in clinical chemistry parameters were limited to decreased albumin and increased 
globulins in individual animals at 200 mg/kg/dose.  These changes were suggestive of a mild 
acute phase response, and were considered non-adverse.  There were no OBI-888-related 
changes in urinalysis parameters occurred during the study. 
The animals of all 4 OBI-888 treated groups (0, 20, 60, and 200 mg/kg) were sacrificed and the 
organs were checked externally and internally and harvested for histopathological examination.  
At terminal (Day 28) or recovery (Day 43) necropsy, there were no gross findings, organ weight 
changes, or microscopic findings.  
Maximum serum concentrations (Cmax) of OBI-888 occurred generally at 1 hour post-dose 
except for 60 mg/kg dosed animal on Day 22 where Cmax was observed at 8 hour post-dose.  
Mean elimination half-life (t1/2), when estimable, ranged from 37.2 to 42.0 hours on Day 1 and 
from 16.3 to 49.9 hours on Day 22.  The mean clearance (Cl) was similar across the dose levels 
and ranged from 1.14 to 1.76 mL/hour/kg on Day 1 and from 1.43 to 2.41 mL/hour/kg on 
Day 22.  The estimated mean volume of distribution (Vd) ranged from 33.3 to 135 mL/kg.  
Systemic exposure (Cmax and total exposure [AUC(0-t)]) to OBI-888 increased with increasing 
dose across the dose ranges.  There was no accumulation of OBI-888 due to repeat 


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administration on Day 22 compared to Day 1 and mean accumulation ratios for AUC(0-144) 
ranged from 0.586 to 1.21.  No gender difference was observed across dose ranges on both days. 
In conclusion, administration of OBI-888 via intravenous (slow bolus) injection once weekly 
for a total of 4 doses (Days 1, 8, 15, and 22) was well tolerated in cynomolgus monkeys at levels 
of 200 mg/kg/dose.  Based on these results, the NOAEL was considered to be 200 mg/kg/ dose. 
4.3 Clinical Studies 
4.3.1 Results from OBI-888-001 
As of March 2020, a total of 17 patients with locally advanced or metastatic solid tumors have 
been enrolled, including 14 patients in the dose escalation phase (at doses of 5, 10, and 
20 mg/kg) and 3 patients in the cohort expansion phase (at the selected recommended phase II 
dose [RP2D] of 20 mg/kg). The dose escalation phase is complete; no dose-limiting toxicities 
were reported and the maximum tolerated dose was not reached. The cohort expansion phase is 
ongoing, with OBI-888 administered at 20 mg/kg.  
There have been 8 serious adverse events (SAEs) reported from 5 patients (from all 3 dose 
cohorts). All SAEs were assessed by the Investigator as unrelated to OBI-888. Two SAEs were 
Grade 5 (both in 1 patient), and the remaining SAEs were Grade 3 in severity. No patient has 
discontinued the study due to treatment related adverse events (AEs). Two (2/17, 11.7%) 
patients died on-study, both due to disease progression. OBI-888 in doses up to 20 mg/kg have 
been generally well-tolerated and no safety concerns have been noted.  
In general, pharmacokinetic (PK) profiles following single-dose administration were similar 
across patients.  Pharmacokinetic analysis showed no significant accumulation in peak 
concentrations (Cmax) after multiple OBI-888 doses. However, accumulation of trough 
concentrations was observed in most patients (12/14, 86%). The mean trough concentrations at 
steady state increased with increasing OBI-888 dose (3.6 μg/mL for Cohort 1 [5 mg/kg], 5.1 
μg/mL for Cohort 2 [10 mg/kg], and 11.3 μg/mL for Cohort 3 [20 mg/kg]). As expected for 
intravenous (IV) administration, Cmax was achieved in most patients by the end of infusion. 
Cmax/D values for each dose ranged from 0.246 to 0.275, suggesting that Cmax was dose 
proportional across the doses tested. AUClast exhibited higher variation across the doses tested, 
however, mean values of AUClast/D and CL were similar across the dose groups. The mean Vz 
ranged from 4.4 to 5.7 L across the dose groups, which is consistent with the expected 
distribution volume of large protein therapeutics. The t1/2 was similar across the dose groups 
(30 hours). 
The incidence of anti-drug antibody (ADA) induction was 1/5 and 1/3 in Cohorts 1 and 2 
respectively. ADCC and complement dependent cytotoxicity (CDC) induction activity were 
observed in all post-injection serum samples, showing a positive correlation with the OBI-888 
serum concentrations detected in the PK study.   
4.3.2 Globo H H-Score in Various Tumor Tissues 
The distribution of immunohistochemistry (IHC) H-scores for Globo H observed in pancreatic, 
esophageal, gastric, colon, breast, lung, and liver cancers are as shown in Figure 4-1.  A total of 
562 specimens including tumor tissue resections and tumor tissue microarray section cores were 
analyzed, including 72 pancreatic cancer, 64 esophageal cancer, 73 gastric cancer, 131 breast 
cancer, 77 lung cancer, 75 colon cancer, and 70 liver cancer.  The prevalence of Globo H cut-off 
varies in different cancer types and are summarized in Table 4-1. 


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Figure 4-1 
Globo H Immunohistochemistry H-Score of Various Tumor Tissues 
 
Table 4-1 
Prevalence of Globo H Cut-Off in Different Cancer Types 
 
 
4.4 Clinical Risks/Benefits of OBI-888  
As this is the first study in humans, there are no known clinical benefits that have been 
determined to be associated with the use of OBI-888.  However, it is hoped that data from this 
clinical study and other trials sponsored by OBI Pharma will demonstrate the clinical benefits 
of OBI-888 in subjects with advanced or metastatic solid tumors. 
4.5 Rationale 
Globo H is a hexasaccharide glycosphingolipid located endogenously on the outer membrane 
of epithelial cells and was first identified in breast cancer cells.  Globo H was found to be 
overexpressed on the cell surface of several epithelial cancers such as breast, pancreatic, 
ovarian, endometrial, gastric, lung, and prostate cancers.  Globo H has been associated with 
tumor stem cells, as a potent inducer of angiogenesis and immune suppressor through Notch 
signaling, rendering it a target for cancer therapy (Cheng, et al., 2014).  
The target population to be enrolled in this study will be patients with advanced or metastatic 
solid tumors refractory to at least one line of systemic therapy or intolerable with standard 


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therapy or for which no standard treatment is available.  In Part B, all subjects will have Globo H 
expression analysis of their tumor in order to obtain a preliminary assessment of OBI-888 
activity in patients whose tumors express the drug target.  In this setting, while additional 
therapy may be available, the duration of PFS and OS could be optimized by new therapies with 
better efficacy and safety profile.  Therefore, based on the above noted preclinical studies 
showing potential anti-tumor activity of OBI-888 in several tumor types, this study is conducted 
with the aim to offer patients the possibility of tumor shrinkage and prolongation of survival 
with this novel monoclonal antibody.  Following the establishment of the safe dose, and 
PK/pharmacodynamic (PD) profile in the escalation phase, the expansion phase will be initiated 
to obtain additional safety data, and assess the preliminary clinical activity profile of OBI-888 
administered as monotherapy in patients with locally advanced or metastatic solid tumors 
patients, and where we had seen signal of tumor inhibition in the preclinical trials.  
The dose levels for this study resulted from calculation based on data from preclinical studies.  
The initial dose chosen for this study is 5 mg/kg administered every week.   
This is a 2-part study: Part A (Dose Escalation) is designed to establish the maximum tolerated 
dose (MTD) of OBI-888 as monotherapy.  Part B (Cohort Expansion) is intended to further 
characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 
administered as monotherapy in patients with locally advanced or metastatic solid tumors. 


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5 
Study Objectives and Endpoints 
5.1 Study Objectives 
5.1.1 Primary Objectives 
The primary objectives are:  
• To evaluate the safety and tolerability of OBI-888 when administered IV to patients with 
locally advanced or metastatic solid tumors. 
• To determine the MTD and RP2D of OBI-888 as monotherapy. 
5.1.2 Secondary Objectives 
The secondary objectives are:  
• To evaluate the preliminary clinical activity profile (objective response rate [ORR], 
clinical benefit rate [CBR], duration of response [DOR], and progression-free survival 
[PFS]) of OBI-888. 
• To evaluate the immunogenicity of OBI-888 (ADAs). 
• To determine the serum PK and PD of OBI-888. 
5.1.3 Exploratory Objectives 
Exploratory objectives are:  
• To assess ADCC and CDC. 
• To identify potential predictive biomarkers.  
• To assess the expression of immune markers including immune checkpoints, in the 
tumor tissue samples.  
• To assess the expression of Globo H and related tumor-associated glycans in the tumor 
tissue  
• To perform glycan analysis of OBI-888. 
5.2 Study Endpoints 
5.2.1 Primary Endpoints   
• Dose-limiting toxicities (DLTs) with OBI-888 
• AEs/SAEs and laboratory abnormalities as graded by National Cancer Institute 
Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 
• MTD and RP2D of OBI-888 
5.2.2 Secondary Endpoints   
• Percentage of patients with ORR, CBR, DOR and PFS according to Response 
Evaluation Criteria in Solid Tumors (RECIST 1.1) 
• Percentage of patients with anti-OBI-888 antibodies (ADAs) in blood 
• PK and PD parameters of OBI-888 
5.2.3 Exploratory Endpoints  
• Globo H and related glycan expression in tumor tissue by IHC 
• ADCC and CDC 
• Identify potential predictive markers by IHC or molecular analysis 
• Tumor infiltrating lymphocytes (TILs), including natural killer (NK) cells, and 
programmed death – ligand 1 (PD-L1) expression in tumor tissue samples by IHC  


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• Killer cell immunoglobulin-like receptor (KIR), human leukocyte antigen (HLA), and 
Fc receptor gamma genotype 
• Glycan analysis of OBI-888 
6 
Investigational Plan 
6.1 Description of Overall Study Design and Plan 
This is a Phase I/II, open-label, dose escalation and cohort expansion study of OBI-888, a 
humanized mAb targeting Globo H, in patients with locally advanced or metastatic solid 
tumors.  
This is a 2-part study.  Part A (Dose Escalation) is designed to establish the MTD and RP2D of 
OBI-888. Part B (Cohort Expansion) is intended to further characterize the safety and clinical 
activity profile of the RP2D dose of OBI-888 administered as monotherapy in patients with 
locally advanced or metastatic solid tumors. 
A Safety Review Committee (SRC) will review the safety data (AEs and laboratory toxicities) 
of each lower level dose cohort, before proceeding to the next dose level during dose escalation 
part. At the end of dose escalation phase, the SRC will review safety and PK data to confirm 
the MTD and establish RP2D, before start of the expansion cohort during the study, as specified 
in a separate charter. 
6.1.1 Part A - Dose Escalation 
The dose escalation part of the study will include 3 cohorts of escalating dose levels of 5, 10, 
and 20 mg/kg, using 3+3 design to identify MTD and RP2D.   
Three patients will be enrolled at the lowest dose level. If none of the 3 patients experiences a 
DLT, the next cohort of 3 patients will be enrolled at the next higher dose level. If 1 of 3 patients 
in the initial dose cohort experiences a DLT, that cohort will be expanded to 6 patients.  If only 
1 of these 6 patients has a DLT, then the next cohort of 3 patients will be enrolled at the next 
higher dose level.  If 2 or more patients of the 3-6 patients in a cohort experience a DLT, dose 
escalation will cease and that dose level will be above the MTD the highest dose where no more 
than 1 of 6 patients has experienced at DLT.  New patients will be enrolled at the previous lower 
(tolerated) dose level until that cohort has 6 patients.  This lower dose level will be considered 
the MTD if ≤1 in 6 patients has a DLT.   
Subject should receive all four planned doses with OBI-888 administered during Cycle 1 to be 
eligible for DLT evaluation, unless they experience a DLT with any dose. A patient who 
withdraws from the study within the DLT evaluation period for reasons other than drug-related 
AE will not be included for DLT evaluation and will be replaced; but can continue to receive 
study treatment after slipped dose, if still eligible for treatment.  
Escalation to higher OBI-888 dose cohort is not permissible during the study. After a DLT is 
experienced by a subjects, dose interruption, modifications or dose delays may apply, as per 
Investigators judgement (refer protocol Section 8.3). 
6.1.2 Part B - Cohort Expansion 
Once Part A (Dose Escalation) is completed, Part B will enroll a maximum of 150 additional 
patients with advanced solid tumors with high Globo H expression (defined as an H-score cutoff 
≥ 100 using a validated IHC assay) across 4 disease specific cohorts and 1 basket cohort based 


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on a Simon two-stage design.  The first-stage of Part B will recruit up to 9 patients in each 
cohort (up to 45 patients in the first stage across all cohorts).  If sufficient evidence of activity 
is observed in the first stage, up to 21 additional patients will be enrolled into that cohort (up to 
105 patient in the second stage across all cohorts).   
Part B will be conducted to obtain additional safety data, characterize the PK and PD profile of 
OBI-888, obtain a preliminary assessment of the clinical activity of OBI-888 in Globo H 
expressing solid tumors, and inform subsequent efficacy-finding clinical development. 
No DLTs have been observed at any dose level tested in Part A, and the MTD has not been 
reached.  Therefore, dosing in Part B will be initiated at the highest dose tested in Part A 
(20 mg/kg OBI-888).  
The following 5 cohorts of patients who have high expression of Globo H by a qualified 
laboratory assessment (ie, Globo H H-score ≥ 100 using a validated IHC assay) will be enrolled 
in Part B. 
• Cohort 1:  Pancreatic cancer 
• Cohort 2:  Esophageal cancer 
• Cohort 3:  Gastric cancer 
• Cohort 4:  Colorectal cancer 
• Cohort 5:  Basket (any solid tumor type other than those included in Cohorts 1 through 
4) 
All patients are required to provide a tumor biopsy sample, either unstained slides (preferred) 
or a formalin fixed paraffin embedded (FFPE) tissue block at the initiation of screening visit for 
screening of Globo H overexpression and confirmation for eligibility of patients for Part B. 
Patients with a confirmed and documented Globo H H-score of ≥ 100 will be eligible for the 
study, and will subsequently enter the 28-day screening period to complete the remaining 
screening procedures. 
Patients will continue to receive treatment with OBI-888 until progressive disease, unacceptable 
toxicity, or decision by the Investigator or patient to discontinue treatment.  
6.1.3 Duration of Study 
The study (Part A and B) includes a screening period (up to 28 days) prior to the first dose of 
OBI-888, a treatment period, and a follow-up period.  Treatment will continue until 
progressive disease, unacceptable toxicity, or decision by the Investigator or patient to 
discontinue treatment. 
For Part B, pre-screening for Globo H tumor sample analysis may occur prior to the screening 
period for participation in the OBI-888-001 study. 
The safety follow-up will be conducted 28 days after the last dose of study treatment. 
6.2 Definition of Dose-Limiting Toxicities 
A DLT is defined as the occurrence of any of the following events, within the first cycle of 
treatment, that are considered to be at least possibly related to OBI-888. All AEs unless they 
have been determined to be not related to study drug will be taken into consideration in 
determining DLTs. NCI-CTCAE version 4.03 will be the basis for the descriptive terminology 
and grading of AEs. 


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DLTs are defined as: 
• Grade 4 neutropenia 
• ≥Grade 3 febrile neutropenia with or without infection 
• Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding 
• ≥Grade 3 nausea and vomiting or diarrhea for more than 72 hours despite optimal 
supportive care 
• Any other ≥Grade 3 non-hematological AE that does not resolve before the next 
infusion.   
The DLT evaluation period is the first cycle; 28 days from start of study treatment.   
6.3 Discussion of Study Design 
This study will be undertaken in patients with advanced cancer that has progressed on prior 
therapy.  In this setting, patients will be seeking to alleviate symptoms of their fatal disease and 
prolong life through exposure to a novel agent.  
Patient safety, and a favorable risk/benefit balance, will be carefully monitored throughout and 
after treatment.  Additionally, attention will be taken to enrolling only patients who are felt to 
be in sufficient condition to undertake this clinical trial, as defined by adequate performance 
status, suitable baseline organ function, and the Investigator’s determination that there are no 
significant comorbid conditions which present undue risk.  Nevertheless, unexpected toxicity 
of the investigational drug may occur, and all patients will have informed consent prior to 
treatment. 
In terms of the study design, escalating cohorts for 5, 10, and 20 mg/kg will be assessed using 
a 3+3 design to identify the MTD and RP2D.  Once the MTD and RP2D are established and 
PK/PD data are carefully evaluated, a cohort expansion will be initiated. The cohort expansion 
will allow for additional safety data, characterize the PK/PD profile of OBI-888, and evaluate 
the preliminary clinical activity profile of OBI-888 administered as monotherapy in patients 
with advanced or metastatic solid tumors.  
7 
Selection and Withdrawal of Patients 
7.1 Inclusion and Exclusion Criteria 
7.1.1 Inclusion Criteria 
Patients must meet all of the following criteria in order to be included in the study: 
1. Male or female patients, 18 years of age or older at the time of consent. 
2. Provide written informed consent prior to performing any study-related procedure. 
3. Histologically or cytologically confirmed patients with advanced or metastatic solid 
tumors will be enrolled, for both Dose Escalation and Expansion. 
4. Patients must have been treated with established standard-of-care therapy, or physicians 
have determined that such established therapy is not sufficiently efficacious, or patients 
have declined to receive standard-of-care therapy.   
5. Measurable disease (i.e., at least one measurable lesion per RECIST, version 1.1) 
(Eisenhauer, et al., 2009). 
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Oken, et 
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7. Adequate organ function defined as: 
a. Hepatic: 
• Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal 
(ULN), ≤5 × ULN in the presence of liver metastases 
• Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in 
presence of liver metastases 
• Serum bilirubin ≤1.5 × ULN (unless due to Gilbert’s syndrome or 
hemolysis) 
b. Renal: 
• Creatinine clearance >30 mL/minute using Cockcroft Gault equation 
c. Hematologic: 
• Absolute neutrophil count ≥1000/µL 
• Platelets ≥75,000/µL 
• Hemoglobin ≥8 g/dL  
8. Patient is willing and able to comply with all protocol-required assessments, visits, and 
procedures, including a pretreatment tumor biopsy.  Archival tumor biopsies (slides or 
FFPE tissue block) are acceptable at baseline.  
9. Females of childbearing potential must have negative serum or urine pregnancy test 
prior to starting study therapy, and agree to use a reliable form of contraceptive during 
the study treatment period and for at least 120 days following the last dose of study 
drug. Subject not of childbearing potential (i.e., permanently sterilized, 
postmenopausal) can be included in study.  Postmenopausal is defined as 12 months 
with no menses without an alternative medical cause. Male patients must agree to use 
an adequate method of contraception during the study treatment period and for at least 
120 days following the last dose of study drug. 
10. Cannot be breast feeding. 
11. Patients in Part B (Cohort Expansion) must have a documented Globo H H-score of at 
least 100 from a qualified laboratory IHC assay in one of the following tumor types to 
be enrolled in the respective cohort: 
o Cohort 1:  Pancreatic cancer 
o Cohort 2:  Esophageal cancer 
o Cohort 3:  Gastric cancer 
o Cohort 4:  Colorectal cancer 
o Cohort 5:  Basket (any solid tumor type other than those included in Cohorts 1 
through 4) 
7.1.2 Exclusion Criteria 
Patients meeting any of the following criteria are ineligible to participate in this study: 
1. Less than 3 weeks, from prior cytotoxic chemotherapy or radiation therapy; and less 
than 5 half-lives or 3 weeks from biological therapies, whichever is shorter, prior to the 
first dose of OBI-888. 
2. Has undergone a major surgical procedure (as defined by the Investigator) or significant 
traumatic injury within 28 days prior to the first dose of OBI-888. 
3. Presence of an active autoimmune or inflammatory disease requiring systemic treatment 


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within the past 2 months or a documented history of clinically severe autoimmune 
disease that requires systemic steroids or other immunosuppressive medications.  Local 
steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, 
topical, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses 
not to exceed 10 mg/day of prednisone or equivalent would not be excluded from the 
study.  
4. Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day 
prednisone or equivalent or other immunosuppressive agents within 14 days prior to the 
first dose of OBI-888.  
5. Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic therapy, 
including known infection with human immunodeficiency virus (HIV) or active 
infection with hepatitis B virus or hepatitis C virus.  Patients with HIV infection are 
eligible if CD4+ T-cell counts are ≥350 cells/µL; patients on antiretroviral therapy 
should be on an established dose for at least 4 weeks and have an HIV viral load less 
than 400 copies/mL prior to enrollment. 
6. Patients with a history of solid organ transplant. 
7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to 
Grade 0 or 1 (using NCI CTCAE version 4.03), except for alopecia and laboratory 
values listed in the inclusion criteria. 
8. Receipt of any prior therapy targeting Globo H. 
9. Known hypersensitivity to OBI-888 or its excipients. 
10. Has known untreated central nervous system metastases. Patients with treated brain 
metastases are eligible if there is no evidence of progression for at least 4 weeks after 
central nervous system-directed treatment, as ascertained by clinical examination and 
brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) 
during the screening period.   
11. Any medical co-morbidity or psychiatric illness that is life-threatening or, in the opinion 
of the Investigator, renders the patient unsuitable for participation in a clinical trial due 
to possible noncompliance, would place the patient at an unacceptable risk, and/or 
potential to affect interpretation of results of the study. 
12. Is receiving any concurrent prohibited medication as listed in Section 8.6.3. 
7.2 Treatment Discontinuation and Withdrawal of Subjects 
A patient who withdraws from the study within the DLT evaluation period for reasons other 
than drug related AE will be replaced.  
A patient may voluntarily withdraw or be withdrawn from the study treatment at any time for 
reasons including, but not limited to, the following: 
• 
Progressive disease 
• 
Grade 4 infusion reactions and OBI-888 related toxicity  
• 
Dose reductions required on more than 2 occasions for toxicity related to OBI-888  
• 
Treatment interruption for more than 2 consecutive doses for related or unrelated 
reasons. 
• 
Patient withdrawal of consent:  At any time, a patient's participation in the study may 
be terminated at his/her request or on the basis of the Investigator’s clinical judgment.   


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• 
Inter-current illness:  A condition, injury, or disease unrelated to the primary diagnosis 
that becomes apparent during treatment and necessitated the patient's termination from 
the study. 
• 
General or specific changes in the patient's condition that renders him/her ineligible for 
further treatment according to the inclusion/exclusion criteria. 
• 
Protocol deviation:  The patient’s findings or conduct fail to meet the protocol entry 
criteria or fail to adhere to the protocol requirements (e.g., drug noncompliance, failure 
to return for defined number of visits). The deviation necessitated premature 
termination from the study. 
Lost to follow-up:  The patient stops coming for visits, and study personnel are unable 
to contact the patient. 
7.3 Follow-Up for Drug Discontinuation/Subject Withdrawal from Study 
If a patient discontinues study treatment and is withdrawn from the study for any reason, the 
study site must immediately notify the Sponsor. The date and the reason for study treatment 
discontinuation / study withdrawal must be recorded on the electronic case report form (eCRF). 
Patients who withdraw prematurely are to attend an early termination visit, if possible, and 
complete all assessments. 
In the event that a patient discontinues prematurely from the study due to a treatment-emergent 
adverse event (TEAE) or serious TEAE, the TEAE or serious TEAE will be followed until it 
resolves (returns to normal or baseline values) or stabilizes, or until it is judged by the 
Investigator to be no longer clinically significant.   
Once a patient is withdrawn from the study, the patient may not re-enter the study. 
8 
Treatments 
8.1 Details of Study Treatment 
OBI-888 (a humanized anti Globo H monoclonal antibody). 
OBI-888 drug product is a colorless to light yellow liquid which is filled in a transparent Type I 
glass vial in solution form, with final concentration 30 mg/mL in 25 mM L-Histidine, 150 mM 
L-Arginine, pH 6.0, 0.02% Polysorbate 80. 
All study drug will be supplied by OBI Pharma Inc., and must remain under adequate security, 
and proper storage condition.  Do not use study drug after the expiration date, which is imprinted 
on the drug container. 
Investigational drug solution should be prepared by mixing the OBI-888 drug product (DP) 
with infusion solution (0.9% saline or 5% glucose) before intravenous infusion.  Refer to 
Appendix 1 and the Pharmacy Manual for study drug preparation instructions. 
8.1.1 Packaging and Labeling 
OBI-888 drug product will be packaged in carton boxes.  Each box will contain ten OBI-888 
vials.  The labels on each kit will meet the applicable regulatory requirements for each country. 
OBI-888 will be packaged and labeled according to current Good Manufacturing Practices 
(GMP) guidelines.  Details of the packaging and labeling are provided in the Pharmacy Manual.  


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8.1.2 Storage 
OBI-888 drug product must be stored at a temperature of 2 to 8⁰ C.  Based on the stability data 
available, the shelf-life of OBI-888 drug product is stable for at least 36 months at 5 ± 3°C.   
8.2 Dosage Schedule 
8.2.1 OBI-888 Doses  
For Part A (Dose Escalation), OBI-888 will be given at doses of 5 mg/kg, 10 mg/kg and 
20 mg/kg to the 3 dose cohorts. 
For Part B (Cohort Expansion) subjects will be treated with 20 mg/kg OBI-888 since no DLTs 
have been observed at any dose level tested in Part A, and the MTD was not reached. 
If during treatment a patient’s body weight changes by >10% from the baseline value, the 
OBI-888 dose should be adjusted. 
8.2.2 Regimen 
OBI-888 will be administered as an IV infusion on Days 1, 8, 15, and 22 of each 28-day cycle 
in Part A and Part B of the study.   
Treatment will continue until progressive disease, unacceptable toxicity, or decision by the 
Investigator or patient to discontinue treatment.  
8.2.3 Duration of Infusion 
OBI-888 investigational drug solution (OBI-888 drug product mixed with saline/glucose 
infusion solution) should be administered as IV infusion by the site staff. 
The infusion should be given for a duration of approximately 90-minute (±10 minutes), for the 
initial two cycles (C1 and C2). 
The infusion duration from Cycle 3 could be reduced, if no infusion related AEs to prior 
infusions occur, to 30 minutes or 60 minutes at the discretion of the Investigator. 
8.3 Dose Modifications and Toxicity Management 
Escalation to higher OBI-888 dose cohort is not permissible during the study.  
Dose modifications for hematologic and non-hematologic toxicity and infusion reactions should 
be independently assessed at each visit. Recommendations for dose modifications for toxicity 
are provided in Table 8-1 below. 
Table 8-1 
OBI-888 Dose Modifications for Toxicity 
Once the dose has been reduced for toxicity and found to be well tolerated, re-escalation may 
be permitted at the Investigator’s discretion. If a subject requires dose reductions on more than 
2 occasions for toxicity related to OBI-888, the subject should discontinue from the study. 
Toxicity 
Hold Dose 
% of Full Dose after 
Recovery to Grade 0-1 
Grade 1 
Do not hold dose 
100 
Grade 2 
Hold dose until resolution to Grade 0 or 1 
75 
Grade 3 
Hold dose until resolution to Grade 0 or 1 
75 
Grade 4 
Treatment should be discontinued 
NA 


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All reasons for treatment modifications should be fully explained.  
The study drug dose which is not administered within the permitted window period of ±3 days, 
must be skipped, and the next dose will be administered as per protocol schedule. Any skipped 
dose due to safety reason and if medically justified, for OBI-888 treatment related or unrelated 
reasons, will not be captured as a protocol deviation for this study.  
Treatment interruption for more than 2 consecutive doses for related or unrelated reasons may 
necessitate discontinuation of study treatment. 
Treatment interruption for intercurrent non-treatment related adverse events will be at the 
Investigator’s discretion and based on the well-being of the patient. All reasons for treatment 
interruption and delays should be fully explained. Treatment for hematologic and 
non-hematologic toxicity may be implemented as clinically indicated according to institutional 
guidelines. Refer Table 8-2 for therapeutic antiemetic and anti-diarrheal recommendations. 
Table 8-2 
Therapeutic Antiemetic and Anti-Diarrheal Recommendations 
Diarrhea and Abdominal Cramping 
Nausea, Vomiting, or Anorexia 
Dicyclomine: Recommended when the predominant 
issue is cramping or abdominal pain 
1st line: 5HT3-inhibitors 
Diphenoxylate/Atropine 
or/and 
Loperamide 
2nd-line: Dexamethasone, ideally in 
combination with a 5HT3-inhibitor. Short term 
use can be very effective 
Other agents: anti-histamines; 
benzodiazepines; proton pump inhibitors; 
dopamine antagonists; cannabinoids 
Hyoscine: Anti spasmodic agents helpful for 
abdominal cramping 
 
Budesonide (Entocort EC): Corticosteroid with 
limited systemic absorption; 9 mg once daily for up 
to 8-12 weeks 
 
8.3.1 Infusion Reactions 
Signs/symptoms of infusion reactions may include: allergic reaction/hypersensitivity (including 
drug fever); arthralgia (joint pain); bronchospasm; cough; dizziness; dyspnea (shortness of 
breath); fatigue (asthenia, lethargy, malaise); headache; hypertension; hypotension; myalgia 
(muscle pain); nausea; pruritic/itching; rash/ desquamation; rigors/chills; sweating 
(diaphoresis); tachycardia; tumor pain (onset or exacerbation of tumor pain due to treatment); 
urticaria (hives, welts, wheals); and vomiting. 
In the event of an infusion reaction, additional serum/plasma samples may be drawn at the time 
of the event to evaluate drug concentration and anti-drug antibody, as well as to assess levels of 
cytokines and/or other markers of inflammation. 
Prophylactic Measures 
Prior to dosing with OBI-888, patients should receive prophylactic treatment for infusion 
reactions consisting of acetaminophen orally and diphenhydramine (or equivalent) orally or IV 
30 to 60 minutes prior to infusion of OBI-888 (recommended doses are: acetaminophen 650 mg, 
diphenhydramine 50 mg). If an alternative premedication regimen is thought to be required, 
Sponsor approval should be sought.  


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For patients who experience an infusion reaction despite initial premedication, additional 
prophylactic treatment may be added prior to subsequent doses, including an H2 blocker such 
as ranitidine, and/or corticosteroids.  
Prophylactic treatment for infusion reactions may be withheld at the Investigator’s discretion if 
no infusion reactions were observed with the first cycle of treatment. 
Management of Infusion Reactions 
In the event of an infusion reaction, the OBI-888 infusion should be interrupted and medical 
therapy administered according to institutional standard of care which, depending upon the 
severity of the event, may include but should not be limited to use of H1 and H2 inhibitors, and 
corticosteroids.  
Patients who experience a Grade 1 or Grade 2 infusion reaction may resume the infusion of 
drug at a reduced infusion rate (30% to 50% slower than initial rate) on the same day following 
appropriate medical management. If the 4-hour window from product reconstitution to 
completion of infusion will be exceeded (Appendix 1), new drug may be prepared to administer 
the remainder of the planned dose. 
Patients who experience a Grade 3 infusion reaction may be retreated at the discretion of the 
Investigator at the next scheduled treatment. Such patients should receive additional 
prophylactic medication that may include a corticosteroid, and the duration of infusion may be 
increased. 
OBI-888 should be permanently discontinued in patients who experience a life-threatening 
(Grade 4) infusion reaction. 
8.4 Study Treatment Assignment 
Patients will be assigned to a dose level in the order of study entry. 
8.5 Treatment Accountability and Compliance 
All drug supplies will be provided by the Sponsor. Administration of study drugs will be 
supervised by study personnel to ensure compliance.  
8.6 Prior and Concomitant Illnesses and Medications 
8.6.1 Prior and Concomitant Illnesses 
Investigators should document all prior significant illnesses that the patient has experienced 
prior to screening.  Additional illnesses present at the time when informed consent is given and 
up to the time of first dosing are to be regarded as concomitant illnesses.  Illnesses first occurring 
or detected during the study and/or worsening of a concomitant illness during the study are to 
be documented as AEs on the eCRF. 
8.6.2 Prior and Concomitant Medications 
All medications and other treatments taken by the patient prior to the start of the study at 
screening and treatments initiated during the study, must be recorded on the eCRF. The entry 
must include the dose, regimen, route, indication, and dates of use. 
After the baseline visit, medication to treat minor illness(es) are generally permitted, including: 


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• Use of localized palliative radiation for pre-existing lesions to control pain, at the 
discretion of the physician. 
• Corticosteroids use: topical, inhaled, ophthalmologic, intra-articular, or intranasal 
corticosteroids; systemic steroids at physiologic doses not to exceed 10 mg/day of 
prednisone or equivalent. For management of side effects including nausea or infusion 
reactions, intermittent prophylactic or therapeutic use of glucocorticoids is allowed at 
doses required for medical therapy administered according to institutional standard of 
care and at the Investigator’s discretion. 
8.6.3 Prohibited Medications 
If there is a clinical indication for the use of one of these prohibited medications, then 
discontinuation from the study drug may be required. 
• Anti-neoplastic therapy, whether approved or experimental, including but are not 
limited to: chemotherapy, immunotherapy, surgery, radiotherapy are not allowed with 
OBI-888. NOTE: Use of localized palliative radiation for pre-existing lesions to 
control pain may be allowed at the discretion of the physician. 
• Immunosuppressive 
therapy 
(e.g., 
cyclosporine, 
rapamycin, 
tacrolimus, 
cyclophosphamide, methotrexate, etc.). 
• Systemic steroids of >10 mg/day prednisone or equivalent  
• Any other concurrent investigational therapy, regardless of indication. 
 
9 
Study Procedures 
Table 9-1 outlines the timing of procedures, and assessments to be performed throughout the 
study.   
The PK sampling schedule is outlined in Table 9-2 (Part A – Dose Escalation) and Table 9-3 
(Part B - Expansion). 
9.1 Subject Informed Consent 
Prior to performing any study-related procedures, the Investigator (or his/her designated staff 
member) will obtain written informed consent from the patient.  
9.2 Procedures by Study Period 
Assessments and study procedures are to be performed as outlined in The Schedule of 
Assessments, Table 9-1.  The PK, ADA, Biomarker, and Glycan Sampling Schedule is provided 
in Table 9-2 (Part A – Dose Escalation) and Table 9-3 (Part B - Expansion).  
The Investigator may at his/her discretion arrange for a patient to have an unscheduled 
assessment, especially in the case of AEs that require follow-up or an AE considered by the 
Investigator to be possibly related to the use of study drug.  The unscheduled visit page on the 
eCRF must be completed. Additional visits to follow-up positive ADA may happen after end 
of study (Table 9-1).  


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Table 9-1 
Schedule of Assessments 
Study Procedure 
Screening Visit** 
Treatment Period 
EoS / ET 
Cycle (C) # 
- 
Cycle 1 
Cycle 2-13 
 
Cycle # and Day  
 
C1D1 
C1D8 C1D15 C1D22 
 
 
Window period (days)  
-28 to -1 days 
-1* 
±1 
±3 
±3 
±3 days 
±7 days 
Informed consenta 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Eligibility screening 
X 
X 
 
 
 
 
 
Medical historyb 
X 
X 
 
 
 
 
 
Physical examinationc 
X 
X 
X 
X 
X 
D1 of each Cycle 
X 
Height, weightd 
X 
X 
X 
X 
X 
D1 of each Cycle 
X 
Vital signse 
X 
X 
X 
X 
X 
D1, D8, D15, D22 of each Cycle 
X 
ECOGf 
X 
 
 
 
 
D1 of each Cycle 
X 
12-lead ECGg 
X 
X 
 
 
 
 
 
Pregnancy testingh 
X 
 
 
 
 
 
X 
Tumor biopsyi 
X** 
 
 
 
 
 
 
Hematology and Biochemistryj  
X 
X 
 
 
 
D1 of each Cycle 
X 
Coagulation and Urinalysisk 
X 
X 
 
 
 
 
 
Drug administrationl 
 
X 
X 
X 
X 
D1, D8, D15, D22 of each 28 day cycle 
 
Pharmacokinetic samplem 
 
See footnote m and Table 9-2 (Part A) and Table 9-3 (Part B) 
Immunogenicity (ADA)n 
 
See footnote n and Table 9-2 (Part A) and Table 9-3 (Part B) 
Biomarkerso 
X 
See footnote o and Table 9-2 (Part A) and Table 9-3 (Part B) 
Radiology evaluations (CT or MRI)p 
X 
 
 
 
 
Q8wk (±1 wk) for the first 6 months,  
then Q12wk (±1 wk) thereafter 
X 
Concomitant medications 
 
Adverse events 
 
 
EOS/ET - End of Study/Early Termination. EoS Visit is the safety follow-up visit, conducted 28±7 days after the last OBI-888 dose. ET visit lab assessments will 
be conducted for subjects discontinuing study treatment, if last available tests are before 2 weeks.  
*The -1 day window (1 day prior) for C1D1 is for safety laboratory assessments. Blood can be drawn 1 day prior to initiation of study drug infusion on C1D1. 
Safety laboratory results should be available and reviewed by the Investigator prior to the OBI-888 administration. 
** All patients are required to provide a tumor biopsy sample, unstained slides (preferred) or a formalin fixed paraffin embedded (FFPE) tissue block at the initiation 
of screening visit for screening of Globo H overexpression and confirmation for eligibility of subjects for Part B. Patients with a confirmed and documented 
Globo H H-score of ≥ 100 are eligible for the study, and will subsequently enter the 28-day screening period to complete the remaining screening procedures. 


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Footnotes:  
a. 
Informed consent to be obtained before any other study procedures are performed. 
b. Medical history to include previous cancer therapies, cancer history, and past and ongoing concomitant illnesses. 
c. 
A complete physical examination is required at screening and at discontinuation.  Directed physical examinations may be limited to problem focused review 
of symptoms and major organ systems at D1 of each cycle and prior to infusion.  
d. Height to be obtained at screening only. Weight obtained at D1 of each cycle, prior to infusion. If during treatment a patient’s body weight changes by >10% 
from the baseline value, the OBI-888 dose should be adjusted. 
e. 
Vital signs include temperature, blood pressure and pulse (at supine position) prior to every infusion. Temperature measurement will be obtained as clinically 
indicated.  
f. 
ECOG performance status: at baseline, C2D1 and end of study/early termination.  
g. 12-lead ECG: at screening and pre and post infusion at C1D1 (within one hour after end of infusion). 
h. Pregnancy testing should be performed in females of childbearing potential only. A urine or serum pregnancy test  is acceptable. 
i. 
Tumor biopsy samples are mandatory at screening visit. Fresh (preferred) tissue or archival tissue is acceptable. A minimum of 3 slides are required for the 
central laboratory Globo H assay for determination of eligibility. Up to 12 unstained additional slides should be provided, depending upon availability, for 
the protocol-defined exploratory studies. 
j. 
Hematology and Serum chemistry (Laboratory Assessments: Table 12-1). Blood draw is prior to OBI-888 infusion.  
Hematology: hematocrit, hemoglobin, red blood cell (RBC) count, white blood count (WBC), absolute counts of leukocytes, neutrophils, lymphocytes, 
monocytes, eosinophils, basophils, and platelet count.  
Serum chemistry: sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, phosphorus, magnesium, total protein, albumin, ALT, AST, 
ALP, creatine kinase, LDH, total bilirubin, and uric acid. Creatinine clearance will be calculated by Cockcroft Gault equation at the screening visit, Week 1 
and EOS/early termination.  
k. Coagulation, and Urinalysis (Laboratory Assessments: Table 12-1). Blood draw and urine collection is prior to OBI-888 infusion. 
Coagulation: PT, aPPT, and INR.  
Urinalysis: specific gravity, pH, protein, glucose, ketones, bilirubin, urobilinogen, blood, nitrite, leukocyte esterase as assessed by dipstick. A microscopic 
urinalysis (only if needed) evaluating white blood cells, red blood cells, epithelial cells, bacteria, cast and crystals 
l. 
OBI-888 is given in cycles with each individual cycle consisting of 28 days (4-week cycle). IP is administered on a weekly basis (within cycle as C1D1, 
C1D8, C1D15, and C1D22; C2D1, C2D8, and so on; until progressive disease, unacceptable toxicity, or decision by the Investigator or patient to discontinue 
treatment. 
m. Pharmacokinetic: (for analysis of serum concentration of OBI-888). Detailed schedules are provided in Table 9-2 (Part A) and Table 9-3 (Part B). 
n. Immunogenicity studies (ADA): ADA samples will be collected at the same time points, along with pre-infusion only PK samples. No post-infusion ADA 
samples will be collected. Detailed schedules are provided in Table 9-2 (Part A) and Table 9-3 (Part B). For subjects with persistent antibodies at end of 
study, an additional ADA sample will be collected at 4 months after the end of study visit. 
o. Biomarker: Detailed schedules are provided in Table 9-2 (Part A) and Table 9-3 (Part B). 
p. Radiology (CT or MRI scan) evaluations of tumor response: Performed during screening and during the study every Q8wk (±1 wk) for the first 6 months,  
then every Q12wk (±1 wk) thereafter. Unscheduled scans can be performed anytime, if needed to confirm disease progression. Radiology assessment for end 
of study follow-up and early termination should be performed unless the patient already has radiographic confirmation of progressive disease or the last 
exam was ≤8 weeks prior to permanent discontinuation of study drug. The same assessment method and the same technique should be used on each patient 
while on study. 
 


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Table 9-2 
Part A – Pharmacokinetic, ADA, Biomarker, and Glycan Sampling Schedule 
Cycle (C) 
Cycle 1 
Cycle 2 
Every 
2 Cyclese, h 
EoS / ET 
Cycle Day 
D1 
D2 
D4 
D8 
D15 
D22 
D1, 8, 15 
D22 
D1 
±7 days 
Pharmacokinetic Samples 
 
 
 
 
 
 
 
 
 
 
  Before infusion 
Xa 
 
 
Xb 
Xb 
Xb 
Xb 
Xb 
Xb 
X 
  End of infusion (90 minutes)c 
X 
Xd 
Xd 
X 
X 
X 
X 
X 
 
 
  1 hour after end of infusion (150 minutes)e 
X 
 
 
 
 
 
 
 
  4 hours after end of infusion (330 minutes)e  
X 
 
 
 
 
 
 
 
 
 
  8 hours after end of infusion (570 minutes)e 
X 
 
 
 
 
 
 
 
 
 
Immunogenicity studies (ADA)f 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Glycan analysisg 
X 
 
 
X 
X 
X 
X 
X 
 
 
Biomarkers 
 
 
 
 
 
 
 
 
 
 
  ADCCi 
X 
 
 
 
X 
 
 
X 
C4D1 
X 
  CDC/ADCCi 
X 
 
 
X 
X 
 
 
 
 
 
  KIR, HLA, Fc receptor gamma genotypingi 
X 
 
 
 
 
 
 
 
 
X 
ADA = antidrug antibody; ADCC = antibody-dependent cell-mediated cytotoxicity; C = cycle; CDC = complement dependent cytotoxicity; D = day; EoS/ET = End 
of Study/Early Termination; HLA = human leukocyte antigen; KIR = killer cell immunoglobulin-like receptor 
Note: OBI-888 infusion should be administered on Days 1, 8, 15, and 22 of every 28 day cycle throughout the study treatment period.  
The infusion duration of Cycle 1 and Cycle 2 are 90 minutes, and can be reduced to 30-60 minutes from Cycle 3, if there were no infusion related adverse events on 
prior infusions and at the discretion of the Investigator. 
a. 
C1D1 Pre-infusion serum samples can be drawn within 1 day prior-to the infusion. 
b. 
Pre-infusion serum samples can be collected at any time prior to the infusion on the day of the infusion. 
c. 
Post infusion samples at the end of infusion and later (at 1, 4, and 8 hours after the end of the infusion) can be collected in a window of ±15 minutes. 
d. 
For Cycle1 Days 2 and 4, a single sample will be collected (window ±2 hours):  
 
24 hours after end of infusion (for infusion at C1D1) 
 
72 hours after end of infusion (for infusion at C1D1) 
e. 
If there is change of the infusion rate or interruption of infusion, the PK sampling at Day 1 are to be collected from the exact time of completion of infusion to 
obtain the post-infusion samples at 1, 4, 8 hour at the end of infusion. Exact time of sample collection and the reason for interruption should be documented in 
the eCRF. 


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f. 
ADA sample will be collected along with the pre-infusion PK samples according to the above table. No post-infusion ADA samples including C1D2 and 
C1D4 will be collected. For subjects with persistent antibodies at end of study, an additional ADA sample will be collected at 4 months after the end of study 
visit. 
g. 
Glycan analysis: pre-infusion and end of infusion in cycle 1 and 2 only. Residual PK and ADA samples will be pooled for glycan analysis after PK and ADA 
data are finalized. 
h. 
Samples to be collected on Day 1 of C4, C6, C8, C10, C12. 
i. 
Biomarkers:  
• 
ADCC (effector cell): pre-infusion blood sample will be collected at C1D1, C1D15, C2D22, C4D1 and end of study/early termination.  
• 
CDC/ADCC (humoral): pre infusion and end-of-infusion blood sample will be collected at C1D1, C1D8, and C1D15. 
• 
KIR, HLA, Fc receptor gamma genotyping: blood sample will be collected at C1D1 (pre-infusion) and end of study/early termination. 
  


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Table 9-3 
Part B – Pharmacokinetic, ADA, and Biomarker Sampling Schedule  
Cycle (C) 
Screening 
Cycle 1 
Cycle 2 
Every 2 
cycles 
starting 
with 
Cycle 3 a 
Every 
2 cycles 
starting 
with 
Cycle 4c 
EoS / ET 
Cycle Day 
-28 
to -1 days 
D1 
D2 
D4 
D8 
D15 
D22 
D1 
D1 
D1 
±7 days 
Pharmacokinetic Samples 
 
 
 
 
 
 
 
 
 
 
 
  Before infusion 
 
Xd 
 
 
Xb 
Xb 
 
Xb 
 
Xb 
 
  End of infusion (90 minutes)f 
 
X 
Xj,k 
Xk 
 
X 
 
 
 
 
 
  1 hour after end of infusion  
  (150 minutes)e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
  3 hours after end of infusion  
  (270 minutes)e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
  6 hours after end of infusion  
  (450 minutes)e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
Immunogenicity studies (ADA)g 
 
X 
 
 
 
 
 
X 
 
X 
X 
Glycan analysish 
 
X 
 
 
X 
X 
 
X 
 
X 
X 
Biomarkers 
 
 
 
 
 
 
 
 
 
 
 
  Globo H 
Xm 
 
 
 
 
 
 
 
 
 
 
  ADCC/CDC (humoral)d,l 
 
X 
 
 
X 
X 
 
 
 
 
 
  KIR, HLA, Fc receptor gamma 
genotypingd 
 
X 
 
 
 
 
 
 
 
 
 
  Multiplex IHCn 
X 
 
 
 
 
 
 
 
 
 
 
  Diagnostic markern 
X 
 
 
 
 
 
 
 
 
 
 
  SSEA-3/SSEA-4n 
X 
 
 
 
 
 
 
 
 
 
 
  Surrogate biomarkerd,i 
 
X 
 
 
 
 
 
 
X 
 
 
ADA = antidrug antibody; ADCC = antibody-dependent cell-mediated cytotoxicity; C = cycle; CDC = complement dependent cytotoxicity; D = day; EoS/ET = End 
of Study/Early Termination; HLA = human leukocyte antigen; IHC = immunohistochemistry; KIR = killer cell immunoglobulin-like receptor; SSEA = stage-
specific embryonic antigens 
Note:  OBI-888 infusion should be administered on Days 1, 8, 15, and 22 of every 28 day cycle throughout the study treatment period.  
The infusion duration of Cycle 1 and Cycle 2 are 90 minutes, and can be reduced to 30-60 minutes from Cycle 3, if there were no infusion related adverse events on 
prior infusions and at the discretion of the Investigator. 
a. 
Samples to be collected on Day 1 of C3, C5, C7, C9, C11, and C13. 
b. 
Pre-infusion serum samples can be collected at any time prior to the infusion on the day of the infusion. 
c. 
Samples to be collected on Day 1 of C4, C6, C8, C10, and C12. 


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d. 
C1D1 Pre-infusion serum samples can be drawn within 1 day prior-to the infusion. 
e. 
If there is change of the infusion rate or interruption of infusion, the PK sampling at Day 1 are to be collected from the exact time of completion of infusion to 
obtain the post-infusion samples at 1, 3, 6 hour at the end of infusion. Exact time of sample collection and the reason for interruption should be documented in 
the eCRF. 
f. 
Post infusion samples at the end of infusion and later (at 1, 3, and 6 hours after the end of the infusion) can be collected in a window of ±15 minutes 
g. 
ADA sample will be collected along with the pre-infusion PK samples according to the above table. For subjects with persistent antibodies at end of study, an 
additional ADA sample will be collected at 4 months after the end of study visit. 
h. 
Glycan analysis: Residual PK and ADA samples will be pooled for glycan analysis after PK and ADA data are finalized. 
i. 
Samples should be collected to evaluate tumor-specific biomarkers (eg, CEA for colorectal, gastric, and esophageal cancer; and CA19-9 for pancreatic 
cancer).  
j. 
This intensive PK sampling will be collected only from first 3 patients in each cohort.  
k. 
For C1D2 and C1D4, samples can be collected in a window of ±2 hours: 
• 
24 hours after end of infusion (for infusion at C1D1). 
• 
72 hours after end of infusion (for infusion at C1D1). 
l. 
Blood sample will be collected pre-infusion and end-of-infusion. 
m. 
For Part B, pre-screening for Globo H tumor sample analysis may occur prior to the screening period for participation in the OBI-888-001 study. 
n. 
Tumor biopsy samples obtained during the initial screening visit should be used for this assessment. 
  


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10 
Clinical Activity Profile Assessments 
Radiology (CT or MRI scan) evaluations (±7 days) of tumor response are to be performed 
during screening within 28 days prior to Cycle 1 Day 1 (first dose of study medication), and 
thereafter during the study every 8 weeks (Q8wk; ± 1 week) for the first 6 months, then every 
12 weeks (Q12wk; ± 1 week). Unscheduled scans can be performed anytime, if needed to 
confirm disease progression. Radiology assessment for end of study follow-up and early 
termination should be performed unless the last exam was ≤ 8 weeks prior to permanent 
discontinuation of study drug. The same assessment method and the same technique should be 
used on each patient while on study. 
Overall tumor response and progression will be evaluated by the Investigator according to 
RECIST, version 1.1.  
11 
Pharmacokinetics 
11.1 Pharmacokinetic Sampling 
Blood samples for pharmacokinetic analysis of OBI-888 levels will be collected at the time 
points indicated in the Pharmacokinetic Sampling Schedules (Table 9-2 [Part A – Dose 
Escalation] and Table 9-3 [Part B – Expansion]).  The actual date and time of each blood sample 
collection will be recorded.  The timing of PK samples may be altered and/or PK samples may 
be obtained at additional time points to ensure thorough PK monitoring. 
Details of PK blood sample collection, processing, storage, and shipping procedures are 
provided in a separate laboratory manual.  
11.2 Pharmacokinetic Analytical Methodology 
The concentration of study drug will be determined from the serum samples using a validated 
analytical method.  Details of the method validation and sample analysis will be included with 
the final clinical study report.  
PK parameters will be calculated using a non-compartmental method from the PK samples 
collected on Dose 1 and will include Cmax, total exposure (AUC), t1/2, Cl, and Vd.  To assess the 
attainment of steady state, trough (Cmin) concentrations and peak concentrations (end of 
infusion) of each dose would be obtained directly from analytical data.   
Pharmacometric methods may also be applied to further investigate OBI-888 exposure 
(e.g., accumulation of OBI-888, presence of dose- or time-dependent OBI-888 PK behavior, 
verification of influential factors on OBI-888 PK). 
12 
Safety Assessments 
Safety assessments (vital signs, physical examinations, ECG recording, AEs, clinical laboratory 
results [routine hematology, serum chemistry, coagulation, and urinalysis]) are to be performed 
at protocol-specified visits, as specified in the Schedule of Assessments, Table 9-1. 
12.1 Vital Signs 
Vital signs (body temperature, heart rate, systolic and diastolic blood pressure measurements) 
will be evaluated at the visits indicated in the Schedule of Assessments (Table 9-1).  All vital 
signs will be measured after the patient has been resting in a supine position for at least 


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5 minutes.  Blood pressure measurements are to be taken in the same arm for the duration of 
the study.  Temperature measurement will be obtained as clinically indicated.  
Body weight (without shoes) will be recorded whenever vital signs are recorded, and height 
(without shoes) will be recorded at screening only. 
Vital sign measurements will be repeated if clinically significant or machine/equipment errors 
occur.  Out-of-range blood pressure, respiratory rate or heart rate measurements will be repeated 
at the Investigator’s discretion.  Any confirmed, clinically significant vital sign measurements 
must be recorded as AEs. 
12.2 Physical Examination 
A complete physical examination (head, eyes, ears, nose, throat [HEENT], heart, lungs, 
abdomen, skin, cervical and axillary lymph nodes, neurological, and musculoskeletal systems) 
will be performed at screening and early termination.  Medical history will be recorded at 
screening, including smoking history, if applicable. 
A limited physical examination to verify continued patient eligibility and to follow up any 
change in medical history will be performed at the visits indicated in the Schedule of 
Assessments (Table 9-1).  Symptom-driven limited physical examinations will be performed as 
clinically indicated at any study visit.  All changes not present at baseline or described in the 
past medical history and identified as clinically noteworthy must be recorded as AEs. 
Medical history will include previous cancer therapies, cancer history, and past and ongoing 
concomitant illnesses.  
12.3 Electrocardiogram 
A 12-lead resting ECG will be obtained at the visits indicated in the Schedule of Assessments 
(Table 9-1). 
At screening, the Investigator will examine the ECG traces for signs of cardiac disease that 
could exclude the patient from the study.  An assessment of normal or abnormal will be recorded 
and if the ECG is considered abnormal, the abnormality will be documented on the eCRF.  
ECGs will be repeated if clinically significant abnormalities are observed or artifacts are 
present. 
12.4 Laboratory Assessments 
Laboratory assessment samples (Table 12-1) are to be obtained at designated visits as detailed 
in the Schedule of Assessments (Table 9-1). 


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Table 12-1 
Laboratory Assessments 
The routine safety laboratory testing will be performed at the local laboratory following the 
lab’s guidelines. PK, ADA and biomarkers will be analyzed at a qualified laboratory facility 
Urine samples will be analyzed by dipstick, and a microscopic analysis will be performed if the 
results of dipstick indicate abnormalities to be further investigated.  All laboratory reports must 
be reviewed, signed, and dated by the Investigator.  Any laboratory test result considered by the 
Investigator to be clinically significant should be considered an AE (clinically significant AEs 
include those that require an intervention).  Clinically significant abnormal values occurring 
during the study will be followed until repeat test results return to normal, stabilize, or are no 
longer clinically significant.  
Hematology 
Serum chemistry 
Urine analysis 
(dipstick) 
Hemoglobin 
Hematocrit 
Platelet count 
Red blood cell (RBC) count  
White blood cell (WBC) count 
 
with differential  
Albumin 
Alanine aminotransferase (ALT) 
Alkaline phosphatase (ALP) 
Aspartate aminotransferase (AST) 
Blood urea nitrogen (BUN) or Urea 
Bicarbonate 
Creatinine 
Creatine kinase  
Electrolytes (Na, K, Cl, Ca, P, Mg) 
Glucose  
Lactate dehydrogenase (LDH) 
Total bilirubin 
Total protein 
Uric acid 
Appearance 
Blood 
pH 
Protein 
Glucose 
Ketones 
Nitrite 
Leukocyte esterase 
Specific gravity 
   
Urobilinogen 
Bilirubin 
Microscopic, as 
needed 
Coagulation 
 
 
Prothrombin time (PT), 
International Normalized Ratio 
(INR) 
Activated partial thromboplastin 
time (aPTT) 
 
 
Serum or Urine Pregnancy test: A pregnancy test will be performed on all female patients of 
child-bearing potential at the screening visit and early termination visit. 


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12.5 Adverse Events 
12.5.1 Adverse Events 
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study 
or, if present at screening, worsens during the study, regardless of the suspected cause of the 
event.  All medical and psychiatric conditions (except those related to the indication under 
study) present at screening will be documented in the medical history eCRF.  Changes in these 
conditions and new symptoms, physical signs, syndromes, or diseases should be noted on the 
AE eCRF during the rest of the study.  Clinically significant laboratory abnormalities should 
also be recorded as AEs.  Surgical procedures that were planned before the patient enrolled in 
the study are not considered AEs if the conditions were known before study inclusion; the 
medical condition should be reported in the patient’s medical history. 
Patients will be instructed to report AEs at each study visit.  All AEs are to be followed until 
resolution or until a stable clinical endpoint is reached. 
Each AE is to be documented on the eCRF with reference to date of onset, duration, incidence, 
severity, relationship to study drug, action taken with study drug, treatment of event, and 
outcome.  Furthermore, each AE is to be classified as being serious or non-serious.  Changes in 
AEs and resolution dates are to be documented on the eCRF. 
For the purpose of this study, the period of observation for collection of AEs extends from the 
time the patient receives the first dose of study treatment (Cycle 1 Day 1) until 28 days after 
end of treatment.  Follow-up of the AE, even after the date of therapy discontinuation, is 
required if the AE persists until the event resolves or stabilizes at a level acceptable to the 
Investigator. 
Specific guidelines for classifying AEs by intensity (Grade) and relationship to study drug are 
given in Table 12-2 and Table 12-3.  The severity of AEs will be graded according to the 
NCI CTCAE version 4.03 (Grades 1 to 5). 
Table 12-2 
Classification of Adverse Events by Intensity (NCI CTCAE Grade) 
MILD (Grade 1): An event that is easily tolerated by the patient, causing minimal discomfort, and 
not interfering with everyday activities. 
MODERATE (Grade 2): An event that is sufficiently discomforting to interfere with normal everyday 
activities. 
SEVERE (Grade 3): An event that prevents normal everyday activities. 
LIFE-THREATENING (Grade 4) 
DEATH (Grade 5) 


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Table 12-3 
Classification of Adverse Events by Relationship to Study Drug 
UNRELATED: This category applies to those AEs that are clearly and incontrovertibly due to 
extraneous causes (disease, environment, etc.). 
UNLIKELY: This category applies to those AEs that are judged to be unrelated to the test drug, but 
for which no extraneous cause may be found.  An AE may be considered unlikely to be related to 
study drug if or when it meets 2 of the following criteria:  (1) it does not follow a reasonable temporal 
sequence from administration of the test drug; (2) it could readily have been produced by the 
patient’s clinical state, environmental or toxic factors, or other modes of therapy administered to the 
patient; (3) it does not follow a known pattern of response to the test drug; or (4) it does not 
reappear or worsen when the drug is re-administered. 
POSSIBLY: This category applies to those AEs for which a connection with the test drug 
administration appears unlikely but cannot be ruled out with certainty.  An AE may be considered 
possibly related if or when it meets 2 of the following criteria: (1) it follows a reasonable temporal 
sequence from administration of the drug; (2) it could not readily have been produced by the 
patient’s clinical state, environmental or toxic factors, or other modes of therapy administered to the 
patient; or (3) it follows a known pattern of response to the test drug. 
PROBABLY:  This category applies to those AEs that the Investigator feels with a high degree of 
certainty are related to the test drug.  An AE may be considered probably related if or when it meets 
3 of the following criteria: (1) it follows a reasonable temporal sequence from administration of the 
drug; (2) it could not be reasonably explained by the known characteristics of the patient’s clinical 
state, environmental or toxic factors, or other modes of therapy administered to the patient; (3) it 
disappears or decreases on cessation or reduction in dose (note that there are exceptions when an 
AE does not disappear upon discontinuation of the drug, yet drug-relatedness clearly exists; for 
example, as in bone marrow depression, fixed drug eruptions, or tardive dyskinesia); or (4) it follows 
a known pattern of response to the test drug. 
DEFINITELY:  
This category applies to those AEs that the Investigator feels are incontrovertibly 
related to test drug.  An AE may be assigned an attribution of definitely related if or when it meets all 
of the following criteria: (1) it follows a reasonable temporal sequence from administration of the 
drug; (2) it could not be reasonably explained by the known characteristics of the patient’s clinical 
state, environmental or toxic factors, or other modes of therapy administered to the patient; (3) it 
disappears or decreases on cessation or reduction in dose and recurs with re-exposure to drug (if 
re-challenge occurs); and (4) it follows a known pattern of response to the test drug. 
When changes in the intensity of an AE occur more frequently than once a day, the maximum 
intensity for the event should be noted.  If the intensity category changes over a number of days, 
then those changes should be recorded separately (with distinct onset dates). 
The severity of AEs will be graded according to the NCI CTCAE version 4.03 (Grades 1 to 5). 
12.5.2 Serious Adverse Events 
An AE is considered “serious” if in the view of either the Investigator or Sponsor, it meets one 
or more of the following criteria:  
• 
Is fatal 
• 
Is life-threatening 
• 
Results in inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
• 
Is a congenital anomaly/birth defect 
Other important medical events that may not be immediately life-threatening or result in death 
or hospitalization, based upon appropriate medical judgment, are considered SAEs if they are 
thought to jeopardize the patient and/or require medical or surgical intervention to prevent one 
of the outcomes defining a SAE. 


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Since SAEs are critically important for the identification of significant safety problems, it is 
important to take into account both the Investigator’s and the Sponsor’s assessment.  If either 
the Sponsor or the Investigator believes that an event is serious, the event must be considered 
serious and evaluated by the Sponsor for expedited reporting. 
Hospitalization is not considered an SAE and should not be reported if it is for social reasons 
in the absence of an AE, or for diagnostic or study-related procedures. 
Disease progression is considered an expected event in this patient population, and should not 
be considered an AE or SAE.  However, any medical event/condition that is untoward in the 
context of disease progression and/or for the specific patient’s disease course should be reported 
as an AE and assessed accordingly by the investigator.   
Progression of disease with a fatal outcome does not need to be reported as an AE.  However 
the applicable protocol CRF page(s) pertaining to death should be completed immediately in 
order to record the disease progression/death. 
12.5.3 Serious Adverse Event Reporting 
An SAE occurring after receiving OBI-888 or within 28 days of stopping the treatment must be 
reported to the contracted contract research organization (CRO) and will be communicated to 
the Sponsor.  Any such SAE due to any cause, whether or not related to the study drug, must be 
reported within 24 hours of occurrence or when the Investigator becomes aware of the event.  
The Investigator must send the SAE information to the Sponsor/contracted CRO using the 
electronic data system (preferred method), by filling out a paper SAE reporting form (to be sent 
via electronic mail or dedicated fax line), or by telephone line.  SAEs occurring after signing of 
the informed consent before and before receiving OBI-888 should be reported only if the SAE 
was directly related to a screening procedure. 
If the Investigator contacts the contracted CRO by telephone, then a written report must follow 
within 24 hours and is to include a full description of the event and sequelae in the AE report 
page of the eCRF. 
The event must also be recorded on the standard AE eCRF.  Preliminary reports of SAEs must 
be followed by detailed descriptions later on, including clear and anonymized photocopies of 
hospital case reports, consultant reports, autopsy reports, and other documents when requested 
and applicable.  SAE reports must be made whether or not the Investigator considers the event 
to be related to the investigational drug. 
Appropriate remedial measures should be taken to treat the SAE, and the response should be 
recorded.  Clinical, laboratory, and diagnostic measures should be employed as needed in order 
to determine the etiology of the problem.  The Investigator must report all additional follow-up 
evaluations to the contracted CRO within 10 calendar days.  All SAEs will be followed until 
the Investigator and Sponsor agree the event is satisfactorily resolved. 
Any SAE that is not resolved by the end of the study or upon discontinuation of the patient’s 
participation in the study is to be followed until it either resolves, stabilizes, returns to baseline 
values (if a baseline value is available), or is shown to not be attributable to the study drug or 
procedures. 
12.5.4 Pregnancy 
Female patients of child-bearing potential must have a negative pregnancy test at the screening 
(serum/urine) and the end of study/early termination visit (serum/urine).  Following 


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administration of study drug, any known cases of pregnancy in female patients will be reported 
until the patient completes or withdraws from the study.  The pregnancy will be reported 
immediately by phone and by faxing/emailing a completed Pregnancy Report to the Sponsor 
(or designee) within 24 hours of knowledge of the event.  The pregnancy will not be processed 
as an SAE; however the Investigator will follow the patient until completion of the pregnancy 
and must assess the outcome in the shortest possible time but not more than 30 days after 
completion of the pregnancy.  The Investigator should notify the Sponsor (or designee) of the 
pregnancy outcome by submitting a follow-up Pregnancy Report.  If the outcome of the 
pregnancy meets the criteria for immediate classification of an SAE (e.g., spontaneous or 
therapeutic abortion [any congenital anomaly detected in an aborted fetus is to be documented], 
stillbirth, neonatal death, or congenital anomaly), the Investigator will report the event by phone 
and by faxing a completed SAE form to the Sponsor (or designee) within 24 hours of knowledge 
of the event.  
12.5.5 Overdose 
The Investigator must immediately notify the Sponsor of any occurrence of overdose with study 
drug. 
12.6 ECOG Performance Status 
ECOG performance status will be evaluated at the visits indicated in the Schedule of 
Assessments (Table 9-1). A summary of ECOG performance status is provided in Table 12-4.  
Table 12-4 
ECOG Performance Status 
Grade 
Description 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, e.g., light house work, office work 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and 
about more than 50% of waking hours 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
5 
Dead 
12.7 Immunogenicity 
Safety assessment will also include evaluation of immunogenicity (ADAs).  Immunogenicity 
assessments are to be performed as outlined in Table 9-2 (Part A – Dose Escalation) and Table 
9-3 (Part B - Expansion).   
If a subject is found to be ADA-positive at the end-of-study, the persistence of the ADA will be 
evaluated by collecting one more sample, 4 months later after the last study visit. The serum 
from each time point will test for anti-OBI-888 antibody concentration by a validated ELISA 
based assay. 


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13 
Exploratory Analyses 
13.1 Blood Samples 
Blood samples will be collected as outlined in Table 9-2 (Part A – Dose Escalation) and Table 
9-3 (Part B - Expansion), and analyzed for ADCC (effector cell), ADCC/CDC (humoral) 
activities, and potential biomarkers which may include KIR, HLA, Fc receptor gamma (FcγR) 
genotyping activities. 
13.2 Tumor Tissue Samples 
Tumor tissue biopsy or tissue samples will be collected at time of screening in both escalation 
and expansion phases of the study from all patients. Fresh (preferred) tissue (ie, unstained 
slides) or archival tissue (ie, FFPE tissue block) is acceptable.  All attempts should be made to 
obtain fresh biopsy specimens. However, if historical sample is available, they should be 
retained along with histology/pathology report, if possible. All fresh biopsy specimens or 
historical samples should be sent to the central laboratory for testing.   
A minimum of 3 slides are required for the central laboratory Globo H assay for determination 
of eligibility. Up to 12 unstained additional slides should be provided, depending upon 
availability, for the protocol-defined exploratory studies. The tumor biopsy samples mandated 
at baseline are to be used for Globo H testing by IHC to clarify the mechanism of action of 
OBI-888. They will also be used to examine the expression of immune markers such as TILs, 
including NK cells, and immune checkpoints such as PD-L1, by IHC, as well as to evaluate 
expression of additional tumor associated glycans.  
Globo H expression by IHC assay will be determined at a qualified laboratory using the tumor 
biopsy sample. Patients who have a confirmed and documented Globo H H-score of ≥ 100 are 
eligible for the study, and will continue with completion of the screening procedures over a 
period of 28 days prior to the first dose of OBI-888. Note that submission of the tumor sample 
for Globo H determination may be performed more than 28 days prior to the first dose (after 
obtaining informed consent), but the other screening evaluations must be performed within the 
28-day window.  
13.3 Glycan Analysis of OBI-888 
Glycan analysis of the Fc portion of OBI-888 mAb will be performed in the pre-infusion and 
end of infusion samples in the first two cycles of treatment (see Table 9-2 [Part A – Dose 
Escalation] and Table 9-3 [Part B – Expansion]). Residual samples from the PK and ADA 
analyses samples will be pooled for glycan analysis after PK and ADA data are finalized.  
Fc-glycans and the terminal sugars of Fc-glycans have been shown to be critical for the safety, 
PK and efficacy (ADCC) of mAb. If the Fc-glycans are completely hydrolyzed, the mAb may 
lose its ADCC activity and anti-tumor efficacy. Modification of Fc-glycans and glycosylation 
patterns may influence the PD and PK behavior of OBI-888. Therefore, these exploratory 
glycan analysis data on OBI-888 may be used to correlate with its clinical efficacy. 


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14 
Statistical Analysis 
A Statistical Analysis Plan (SAP) will be prepared after the protocol is approved.  This 
document will provide further details regarding the definition of analysis variables and analysis 
methodology to address all study objectives.  The SAP will serve as a compliment to the 
protocol and supersedes it in case of differences. 
The statistical evaluation will be performed using the Statistical Analysis Software (SAS®) 
Version 9.4 or higher (SAS Institute, Cary, NC).   
Analyses will be conducted by dose level in the dose escalation phase and by cohort in the 
expansion phase.  Descriptive summaries for categorical variables will include counts and 
percentages.  Descriptive summaries for continuous variables will include means, medians, 
standard deviations, minimum and maximum values.  Descriptive summaries of time to event 
data will include medians and confidence intervals.  Graphical summaries of the data may be 
presented.  All data will be listed for all patients.   
Further details of the analysis, including the handling of missing data, transformations, other 
data handling procedures, and analytical methodology will be provided in the SAP.  Additional 
exploratory analyses of the data will be conducted as deemed appropriate. 
14.1 Determination of Sample Size 
This is a 2-part study: Part A Dose Escalation and Part B Cohort Expansion.   
Up to 18 patients will be enrolled in the 3+3 dose escalation phase (Part A).   
The cohort expansion phase (Part B) will enroll up to 150 total patients based on a Simon 
two-stage design.  The first stage will recruit up to 9 patients in each cohort.  If at least 
1 objective response is observed within the first 6 cycles of therapy, a second stage recruitment 
will occur with up to 21 additional patients enrolled into that cohort, for a total of up to 
30 patients per cohort.  If at least 4 objective responses are observed within the first 6 cycles of 
therapy in 30 patients, then OBI-888 will be considered worthy of further evaluation in that 
indication.  This design is based on a level of low interest for a treatment with an ORR of 5% 
versus a level of high interest for a treatment with an ORR of 25%.  The sample size is based 
on a one sided alpha of 0.05 and 90% power.  The two-stage design limits the number of patients 
treated for a treatment with low levels of activity. 
14.2 Analysis of Populations 
The population to be analyzed will include all enrolled patients who receive at least 1 dose of 
study drug.  This population will be used for all analysis on the safety and clinical activity 
profile.  
14.3 Preliminary Clinical Activity Profile Analysis 
ORR will be summarized as the percentage of patients with confirmed partial response (PR) or 
complete response (CR) according to RECIST version 1.1.  CBR will be summarized as the 
percentage of patients with confirmed CR, PR, or stable disease (SD).  DOR, defined as time 
from the date of reported confirmed PR or CR to the date of progression will be summarized 
descriptively using summary statistics. Additionally, a listing of DOR for those patients 
experiencing response will be provided.  PFS is defined as the time from first dose of study 
drug until radiographically determined disease progression or death due to any cause, whichever 


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event occurs first.  Patients who are still alive or who have no progressive disease reported at 
analysis will be censored at their last evaluable tumor assessment.   
Time to progression, death, and/or censoring will be reported for all patients.  Kaplan Meier 
estimates and 95% confidence intervals will be presented for time to event endpoints such as 
PFS if sufficient numbers of events to calculate meaningful statistics are observed. 
14.4 Pharmacokinetic Analysis 
PK parameters will be calculated using a non-compartmental method from the PK samples 
collected on Dose 1 and will include Cmax, total exposure (AUC), t1/2, Cl, Tmax, and Vd.  To 
assess the attainment of steady state, trough (Cmin) concentrations and peak concentrations (end 
of infusion) of each dose would be obtained directly from analytical data.   
Summary statistics will be tabulated for the PK parameters of OBI-888 on Dose 1.  Geometric 
means and coefficients of variation will be presented for Cmax, AUC, t1/2, Cl, and Vd.  Median, 
minimum, and maximum will be presented for Tmax.  
To describe the dependency on dose, scatter plots of Cmax and AUC versus dose will be 
provided.  Summary statistics will be tabulated for the trough (Cmin) concentration and peak 
concentrations (end of infusion) by dose and study day.  To assess the attainment of steady state, 
geometric mean Cmin values will be plotted versus study day by dose. 
Pharmacometric methods may also be applied to further investigate OBI-888 exposure 
(e.g., accumulation of OBI-888, presence of dose- or time-dependent OBI-888 PK behavior, 
verification of influential factors on OBI-888 PK). 
Based on the PK data (PK profile of first dose, steady-state trough serum concentrations, Ctrough, 
or Cmin,ss) and targeted concentration (IC50 in xenograft model), a PK modeling will be carried 
out for various dose regimens including 15 mg/kg weekly, 15 mg/kg every 2 weeks, or 
15  mg/kg q3 weeks. Simulated Ctrough of desired regimen should be above the targeted serum 
concentration. The steady-state trough serum concentrations should be above 2.4 ug/mL, from 
the preclinical xenograft model exhibiting IC50 (trough level at 50% tumor inhibition) of 
2.4 ug/mL. 
14.5 Safety Analysis 
AEs will be coded according to Medical Dictionary for Regulatory Activities (MedDRA) 
version 19.0 or higher and assessed for severity using CTCAE version 4.03. AEs will be 
summarized by system organ class and preferred term and presented in decreasing order of 
incidence.  DLTs will also be summarized by dose and cohort.  The incidence of TEAEs (events 
with onset dates on or after the start of the study drug) will be included in incidence tables.  
Events with missing onset dates will be included as treatment-emergent.  If a patient experiences 
more than 1 occurrence of the same AE, the occurrence with the greatest severity and the closest 
association with the study drug will be used in the summary tables.  SAEs and AEs causing 
discontinuation will be tabulated.  All AEs will be listed by patient, along with information 
regarding onset, duration, relationship and severity to study drug, action taken with study drug, 
treatment of event, and outcome. 
Vital signs, ECG data, hematology, serum chemistry, coagulation, and urinalysis parameters 
from baseline and during study will be examined.  Treatment emergent changes in key 
laboratory parameters will be identified.  Clinical laboratory data and vital signs will be 


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summarized for each time point evaluated using descriptive statistics including mean values 
and mean change from baseline values, as well as numbers of patients with values outside limits 
of the normal range at each time point.  
Summary tables will be provided for concomitant medications initiated prior to study 
enrollment or during the study period. 
14.6 Safety Review Committee (SRC) 
The SRC for OBI-888-001 study will comprise of the clinical lead, medical monitor and the 
study Investigator(s) or designee. The SRC will act in an advisory capacity to monitor patient 
safety and efficacy during the trial.  
This Committee will convene after each cohort completes the first cycle of treatment during the 
dose escalation phase, to review safety data (AEs and laboratory toxicities) to determine 
whether DLTs have occurred. Based on DLTs in Part A with consideration of available PK and 
PD data, RP2D for Part B (Cohort Expansion) will be recommended by SRC. The Committee 
will convene at regular intervals during the conduct of the Cohort Expansion portion of the 
study to assess safety and activity. 
14.7 Interim Analysis 
Not applicable. There is no interim analysis planned for this study. 
15 
Study Management 
15.1 Approval and Consent 
15.1.1 Regulatory Guidelines 
This study will be conducted in accordance with the accepted version of the Declaration of 
Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, Subpart D, of 
Title 21 of the Code of Federal Regulations (CFR), and in compliance with good clinical 
practices (GCP) guidelines. 
15.1.2 Institutional Review Board/Independent Ethics Committee 
Conduct of the study must be approved by an appropriately constituted Institutional Review 
Board (IRB)/Independent Ethics Committee (IEC).  Approval is required for the study protocol, 
Investigator’s Brochure (IB), protocol amendments, informed consent forms (ICFs), and patient 
information sheets.   
15.1.3 Informed Consent 
For each study patient, written informed consent will be obtained prior to any protocol-related 
activities.  As part of this procedure, the Principal Investigator or one of his/her associates must 
explain orally and in writing the nature, duration, and purpose of the study, and the action of 
the drug in such a manner that the patient is aware of the potential risks, inconveniences, or 
adverse effects that may occur.  The patient should be informed that he/she may withdraw from 
the study at any time, and the patient will receive all information that is required by local 
regulations and International Conference on Harmonization (ICH) guidelines.  The Principal 
Investigator will provide the Sponsor or its representative with a copy of the IRB/IEC-approved 
ICF prior to the start of the study. 


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15.2 Data Handling 
Any data to be recorded directly on the CRFs (to be considered as source data) will be identified 
at the start of the study.  Data reported on the CRF that are derived from source documents 
should be consistent with the source documents, or the discrepancies must be explained. 
Concomitant medications entered into the database will be coded using the World Health 
Organization (WHO) Drug Reference List.  AEs will be coded using the MedDRA terminology.  
Clinical data will be entered on eCRFs for transmission to the Sponsor.  Data on eCRFs 
transmitted via the web-based data system must correspond to and be supported by source 
documentation maintained at the study site, unless the study site makes direct data entry to the 
databases for which no other original or source documentation is maintained.  In such cases, the 
study site should document which eCRFs are patient to direct data entry and should have in 
place procedures to obtain and retain copies of the information submitted by direct data entry.  
All study forms and records transmitted to the Sponsor must carry only coded identifiers such 
that personally identifying information is not transmitted.  The primary method of data 
transmittal is via the secure, internet-based electronic data capture (EDC) system.  Access to 
the EDC system is available to authorized users via the study’s Internet web site, where an 
assigned username and password are required for access. 
Any changes made to data after collection will be made through the use of Data Clarification 
Forms (DCF).  The eCRFs will be considered complete when all missing and/or incorrect data 
have been resolved. 
15.3 Source Documents 
Source documents are considered to be all information in original records and certified copies 
of original records of clinical findings, observations, data or other activities in a clinical study 
necessary for the reconstruction and evaluation of the study. 
15.4 Record Retention 
Study records and source documents must be preserved for at least 15 years after the completion 
or discontinuation of/withdrawal from the study or 2 years after the last approval of a marketing 
application in an ICH region, whichever is the longer time period. 
The Investigator agrees to comply with all applicable federal, state, and local laws and 
regulations relating to the privacy of patient health information, including, but not limited to, 
the Standards for Individually Identifiable Health Information, 45 CFR, Parts 160 and 164 (the 
Health Insurance Portability Accountability Act of 1996 [HIPAA] Privacy Regulation).  The 
Investigator shall ensure that study patients authorize the use and disclosure of protected health 
information in accordance with HIPAA Privacy Regulation and in a form satisfactory to the 
Sponsor. 
15.5 Monitoring 
The study will be monitored to ensure that it is conducted and documented properly according 
to the protocol, GCP, and all applicable regulatory requirements.  
On-site and remote (if available) monitoring visits will be made at appropriate times during the 
study.  Clinical monitors must have direct access to source documentation in order to check the 
completeness, clarity, and consistency of the data recorded in the eCRFs for each patient.   


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The Investigator will make available to the clinical monitor source documents and medical 
records necessary to complete eCRFs.  In addition, the Investigator will work closely with the 
clinical monitor and, as needed, provide them appropriate evidence that the conduct of the study 
is being done in accordance with applicable regulations and GCP guidelines.  
15.6 Quality Control and Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, and reliability of the study 
data presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor will arrange audits as part of the implementation of quality assurance to ensure 
that the study is being conducted in compliance with the protocol, Standard Operating 
Procedures, GCP, and all applicable regulatory requirements.  Audits will be independent of 
and separate from the routine monitoring and quality control functions.  Quality assurance 
procedures will be performed at study sites and during data management to assure that safety 
and preliminary clinical activity profile data are adequate and well documented.  
15.7 Protocol Amendment and Protocol Deviation  
15.7.1 Protocol Amendment 
Amendments to the protocol that entail corrections of typographical errors, clarifications of 
confusing wording, 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 IRB/IEC for information only.  The Sponsor will 
ensure that acknowledgement is received and filed.  Amendments that are classed as substantial 
amendments must be submitted to the appropriate Regulatory Authorities and the IRBs/IECs 
for approval. 
15.7.2 Protocol Deviations 
Should a protocol deviation occur, the Sponsor must be informed as soon as possible.  Protocol 
deviations and/or violations and the reasons for which they occurred will be included in the 
clinical study report.  Reporting of protocol deviations to the IRB/IEC and in accordance with 
applicable Regulatory Authority requirements is an Investigator responsibility. 
15.8 Ethical Considerations 
This study will be conducted in accordance with the accepted version of the Declaration of 
Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, Subpart D, of 
Title 21 of the CFR, and in compliance with GCP guidelines. 
IRBs/IECs will review and approve this protocol and the ICF.  All patients are required to give 
written informed consent prior to participation in the study.   
15.9 Financing and Insurance 
Prior to the study commencing, the Sponsor (or its designee) and the Investigator (or the 
institution, as applicable) will agree on costs necessary to perform the study.  This agreement 
will be documented in a financial agreement that will be signed by the Investigator (or the 
institution signatory) and the Sponsor (or its designee).  


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The Investigator is required to have adequate current insurance to cover claims for negligence 
and/or malpractice.  The Sponsor will provide insurance coverage for the clinical study as 
required by national regulations. 
15.10 Publication Policy and Disclosure of Data  
Both the use of data and the publication policy are detailed within the clinical study agreement.  
Intellectual property rights (and related matters) generated by the Investigator and others 
performing the clinical study will be patient to the terms of a clinical study agreement that will 
be agreed between the Institution and the Sponsor or their designee.  With respect to such rights, 
the Sponsor or its designee will solely own all rights and interests in any materials, data, and 
intellectual property rights developed by Investigators and others performing the clinical study 
described in this protocol, patient to the terms of any such agreement.  In order to facilitate such 
ownership, Investigators will be required to assign all such inventions either to their Institution 
or directly to the Sponsor or its designee, as will be set forth in the clinical study agreement. 


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16 
References 
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Determinant Recognized by a Monoclonal Antibody (MBr1) which Specifically Binds to 
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[Cheng JY, Wang SH, Lin J, et al. (2014)]. Globo-H Ceramide Shed from Cancer Cells 
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[Eisenhauer EA, Therasse P, Bogaerts J, et al. (2009)]. New response evaluation criteria in 
solid tumours: revised RECIST Guideline (Version 1.1).  Eur J Oncol 45:228-47.  
[Menard S, Tagliabue E, Canevari S, et al. (1983)]. Generation of Monoclonal Antibodies 
Reacting with Normal and Cancer Cells of Human Breast. Cancer Res. 43: 1295-1300. 
[Oken MM, Creech RH, Torney DC, et al. (1982)]. Toxicity and Response Criteria of the 
Eastern Cooperative Oncology Group.  Am J Clin Oncol  5: 649-655. 
[Ragupathi G, Slovin SF, Adluri S, et al. (1999)]. A Fully Synthetic Globo H Carbohydrate 
Vaccine Induces a Focused Humoral Response in Prostate Cancer Patients:  A Proof of 
Principle. Angewandte Chemie International Edition. 38: 563-566. 
[Richards, JO, Karki S, Lazar GA, et al. (2008)].  Optimization of Antibody Binding to 
FcγRIIa Enhances Macrophage Phagocytosis of Tumor Cells.  Mol. Cancer Ther. 7: 2517-27. 
[Tsai YC, Huang JR, Cheng JY, et al. (2013]. A Prevalent Cancer Associated Glycan, Globo 
H Ceramide, Induces Immunosuppression by Reducing Notch1 Signaling. Journal of Cancer 
Science & Therapy. 5(7): 264-270. 
[Zhou Z, Liao G, Mandal SS, et al. (2015)]. A Fully Synthetic Self-Adjuvanting Globo H-
Based Vaccine Elicited Strong T Cell mediated Antitumor Immunity. Chemical Science 6 
(12):7112-7121 


OBI Pharma, Inc. 
Confidential 
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Protocol OBI-888-001, V 5.0, 08-May-2020 
OBI-888 (a humanized anti Globo H mAb) 
 
 
17 
Appendices 
17.1 Appendix 1 Drug Preparation Instruction for OBI-888 
1. OBI-888 
• 
Dosage intravenous infusion: according to clinical protocol Section 8.2 Dosage Schedule.  The 
dosage will include dose levels of 5, 10, and 20 mg/kg.  
2. Storage Condition:   
• 
OBI-888 vials are to be stored at 2-8oC.   
3. Investigational Drugs: 
• 
OBI-888 fill concentration and volume: 30 mg/mL, 5 mL/vial in 10 mL vial. 
Contents:  30 mg/mL OBI-888 in 25 mM L-Histidine, 150 mM L-Arginine, pH 6.0, 0.02% 
Polysorbate 80. 
At time of treatment, calculate the volume of OBI-888 DP needed according the treatment dosage.  
Withdraw the volume from OBI-888 DP vial by using a sterile syringe and add the volume into an 
infusion bag containing 500 mL 0.9% Saline or 5% glucose.  Mix infusion bag by gently inverting 
the bag 4~5 times.  Do not shake the infusion bag vigorously. 
Drug product should be reconstituted within 1 hour after removal from the refrigerator.  The 
combined OBI-888 and infusion solution, 0.9% normal saline or 5% glucose, is stable up to 48 hours 
from the time of reconstitution at room temperature.  The administration of the drug must be 
completed within 4 hours after reconstitution to minimize potential microbial growth.  If 
reconstitution and administration are not possible within the above time limits, the combined product 
should be destroyed according to the institutional pharmacy Standard Operating Procedure and 
documented in the drug accountability records. 


OBI Pharma, Inc. 
Confidential 
Page 60 
Protocol OBI-888-001, V 5.0, 08-May-2020 
OBI-888 (a humanized anti Globo H mAb) 
 
 
 
4. Illustration of Drug Preparation Procedures 
 

SAP_001.pdf: 
 
OBI Pharma, Inc. 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
 
PROTOCOL OBI-888-001 
A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the 
Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of 
OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors 
 
 
Protocol code:  
OBI-888-001 
SAP Version:  
Final 2.0 
SAP Date:  
02 June 2022 
Author:  
 
 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 2 of 51 
 
1. 
DOCUMENT HISTORY 
VERSION HISTORY 
 
Version # 
Version Date 
Author 
1.0 
31-AUG-2021 
 
 
2.0 
02-JUN-2022 
 
 
REVISION HISTORY 
 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
2.0 
Throughout the 
document 
Editorial changes and updates 
to reflect an abbreviated CSR 
(aCSR). 
After 01Dec2021 Sponsor 
elected to generate an aCSR 
focusing on safety and 
exposure.   
 
3.0 
Sentence added about aCSR. 
To clarify the scope of the TFLs 
that will be generated. 
5.3  
Section on Data Safety 
Monitoring Board renamed to 
Safety Review Committee 
(SRC) and details on SRC 
responsibilities added. 
Text added to reflect the 
protocol. 
8.0 
Sentence “Exploratory analyses 
will be conducted by OBI 
Translational Biology (or their 
designee) and may be included 
in the aCSR.” added. 
To clarify responsibilities. 
8.0 - 8.3 
Added asterisks to show which 
endpoints will be analyzed 
The aCSR will not include all 
endpoints planned in the 
protocol. 
9.0, 10.7 
Update analysis populations. 
Since safety is now the main 
focus of the analysis, the 
analysis populations will be 
limited to safety and PK 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 3 of 51 
 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
populations. 
10.2 
Sentence “Per protocol, 
assessments performed at Day 
1 should be obtained prior to 
infusion of the study drug. As 
only dates (without time) of 
assessments are recorded, the 
last assessment with date prior 
or same as the first dose date 
will be considered baseline.” 
Added. 
To clarify selection of baseline 
assessment. 
10.3, 10.7.2 
Removal of ORR, DOR and 
PFS endpoints. 
ORR, PFS and DOR analyses 
will no longer be conducted. 
10.4, 10.5, 10.6, 
10.6.2, 10.7.1, 
10.7.2, 10.8.2, 
10.8.3, 10.8.4, 
10.8.5 
Remove description of 
summary tables. 
Analyses removed to support 
aCSR which focuses on safety 
and exposure. 
 
10.6.1 
Summary for Globo-H score at 
baseline added. 
To reflect mock-up TFLs table 
14.1.2.1 content. 
10.6.1 
Weight at screening changed to 
weight at baseline. 
To correctly describe baseline 
characteristics that will be 
summarized. 
10.6.2 
Time since initial diagnosis 
(months) and tumor size at first 
diagnosis (mm) added. 
Added to provide better 
presentation of patients’ 
baseline characteristics. 
10.6.2 
Cancer type for Part A 
removed. 
To reflect data collected in the 
eCRF. 
10.6.3 
Subsection “Other Patient 
Characteristics” added. 
To clarify patient characteristics 
that will be summarized only in 
listings. 
10.7.1 
Dose limiting toxicities (DLTs) 
categories modified. 
 
To reflect data collected on 
eCRF. 
 
10.7.1 
Added asterisks to show which 
adverse events will be 
analyzed. 
The aCSR will not include all 
adverse events planned in the 
SAP v1.0. 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 4 of 51 
 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
10.7.1 
Treatment emergent adverse 
event (TEAE) definition added. 
NCI CTCAE version changed 
from 5.0 to 4.03. 
Relationship to study drug 
terms modified. 
Description of TEAE listing 
leading to study drug 
discontinuation modified, 
information on reporting to 
which drug(s) has been 
discontinued removed. 
To follow protocol terminology. 
10.7.1 
Added TEAEs leading to death 
to list of tables that will be 
produced 
Correction of omission. 
10.7.1 
Following paragraphs removed: 
AEs will be summarized by 
study part, dose, cohort, system 
organ class (SOC), preferred 
term (PT), severity grade, and 
relationship to treatment. SAEs, 
deaths, and AEs leading to 
early treatment discontinuation 
(collected on Adverse Events 
eCRF page) will be 
summarized. 
All the dose escalation 
incidences of AEs, SAEs, 
abnormal laboratory 
parameters, clinically significant 
laboratory abnormalities, and 
vital signs will be reported as 
well.  
Not to repeat information which 
is provided in detail in the same 
section.  
 
 
 
 
 
 
 
 
 
10.7.1 
Instead of producing a listing 
with DLTs, DLT flag is included 
in the listing with all AEs. 
To clarify which listings are 
produced. 
 
10.7.1 
Listing with AEs grade ≥ 3 
added. 
Correction of omission. 
 
10.7.2 
Definition of CBR modified:  
confirmed complete response 
(CR) and confirmed partial 
response (PR) should be used. 
Text added to follow the 
protocol. 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 5 of 51 
 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
10.7.2 
Sentence “PK and PD analyses 
will be performed by OBI 
Pharma, Inc.” added. 
To clarify the responsibilities. 
10.8.1 
Units corrected for actual dose 
received from mg/kg to mg. 
To reflect units collected on 
eCRF. 
10.8.1 
Repeated analyses removed. 
 
For consistency. 
10.8.1 
Number of total doses received 
added. 
To reflect mock-up TFL table 
14.3.1.1 content. 
 
10.8.2 
“No CTCAE grade” changed to 
“grade 0”. 
For consistency with mock-up 
TFL table 14.3.12.1.1. 
10.8.2 
Summary for worst-post 
baseline NCI CTC grade for 
applicable laboratory tests 
added. 
Added to provide better 
presentation of laboratory 
results. 
10.8.2 
Pregnancy results will be listed. To clarify what laboratory data 
will be listed. 
10.8.3 
Changes from baseline for vital 
signs added. 
To reflect mock-up TFL table 
14.3.14.1-2 content. 
20 
Programming specification 
section removed 
Not to repeat information which 
is included in Mock-Up Tables, 
Figures and Listings document. 
 


Statistical Analysis Plan: OBI-888-001 
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Version: 2.0 
 
Version Date: 02JUN2022 
Page 6 of 51 
 
APPROVAL SIGNATURES 
STUDY TITLE: A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study 
Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and 
Therapeutic Activity of OBI-888 in Patients with Locally Advanced or Metastatic Solid 
Tumors 
PROTOCOL NUMBER: OBI-888-001(V 5.0, 08-May-2020) 
SAP Final 2.0, 02-JUN-2022 
 
 
Author: 
 
Signature: 
................................................................ 
Date: ...................... 
 
Peer-reviewer Statistician: 
 
Signature: 
........... .................................................... 
Date: ...................... 
 
Medical Writer:
 
Signature: 
........... .................................................... 
Date: ...................... 
 
Project Manager: 
 
Signature: 
................................................................ 
Date: ...................... 
 
 
OBI Pharma 
Biostatistical Consultant: 
 
Signature: 
................................................................ 
Date: ...................... 
 
Medical Monitor: 
 
Signature: 
................................................................ 
Date: ...................... 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
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Version Date: 02JUN2022 
Page 7 of 51 
 
TABLE OF CONTENTS 
1. 
DOCUMENT HISTORY .................................................................................................................................... 2 
2. 
LIST OF ABBREVIATIONS .............................................................................................................................. 9 
3. 
INTRODUCTION ........................................................................................................................................... 11 
4. 
STUDY OBJECTIVES .................................................................................................................................... 11 
4.1 
Primary Objectives ..................................................................................................................................... 11 
4.2 
Secondary Objectives ................................................................................................................................ 11 
4.3 
Exploratory objectives ................................................................................................................................ 11 
5. 
STUDY DESCRIPTION .................................................................................................................................. 11 
5.1 
Study Design ............................................................................................................................................. 11 
5.1.1 
Part A-Dose Escalation .................................................................................................................. 12 
5.1.2 
Part B-Cohort Expansion ................................................................................................................ 12 
5.2 
Study Treatment ........................................................................................................................................ 13 
5.3 
Safety Review Committee ........................................................................................................................... 13 
6. 
RANDOMIZATION AND BLINDING ................................................................................................................ 13 
7. 
SAMPLE SIZE AND POWER CALCULATION .................................................................................................. 14 
8. 
ANALYSIS ENDPOINTS ................................................................................................................................ 14 
8.1 
Primary endpoints: ..................................................................................................................................... 14 
8.2 
Secondary endpoints: ................................................................................................................................. 14 
8.3 
Exploratory endpoints: ................................................................................................................................ 14 
9. 
ANALYSIS POPULATIONS ............................................................................................................................ 15 
10. 
ANALYTICAL PLAN AND STATISTICAL METHODS ........................................................................................ 15 
10.1 
General Conventions and Statistical Considerations ..................................................................................... 15 
10.2 
Definition of Baseline, Study Visits, and Visit Windows ................................................................................. 16 
10.3 
Handling of Missing Data ............................................................................................................................ 16 
10.4 
Patient Disposition ..................................................................................................................................... 16 
10.5 
Protocol Deviations .................................................................................................................................... 16 
10.6 
Patient Characteristics ................................................................................................................................ 17 
10.6.1 
Baseline and Demographic Characteristics .................................................................................... 17 
10.6.2 
Cancer diagnosis history ................................................................................................................ 17 
10.6.3 
Other Patient Characteristics .......................................................................................................... 17 
10.7 
Analysis of Study Endpoints ........................................................................................................................ 17 
10.7.1 
Primary Endpoints .......................................................................................................................... 18 
10.7.2 
Secondary Endpoints ..................................................................................................................... 19 
10.7.3 
Exploratory Endpoints .................................................................................................................... 20 
10.8 
Safety Endpoints ........................................................................................................................................ 21 
10.8.1 
Exposure to Study Treatment ......................................................................................................... 21 
10.8.2 
Laboratory Data .............................................................................................................................. 21 
10.8.3 
Vital Signs ...................................................................................................................................... 21 
10.8.4 
Electrocardiogram .......................................................................................................................... 21 
10.8.5 
Other Safety Parameters ................................................................................................................ 21 
11. 
DEVIATIONS FROM ANALYSIS AS DESCRIBED IN THE PROTOCOL .............................................................. 22 
12. 
LIST OF TABLES, LISTINGS, AND FIGURES .................................................................................................. 22 
13. 
REFERENCES .............................................................................................................................................. 22 
14. 
APPENDIX I. SCHEDULE OF ASSESSMENTS ................................................................................................ 23 
15. 
APPENDIX II IMPUTATION RULES FOR MISSING DATES ............................................................................... 30 
16. 
APPENDIX III. PHARMACOKINETIC ANALYSIS PLAN .................................................................................... 32 
Pharmacokinetic Analysis Plan Signature Page ......................................................................................................... 33 
Modification History ................................................................................................................................................ 34 
Table of Contents ................................................................................................................................................... 35 


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1. 
Introduction ............................................................................................................................................... 37 
2. 
CLINICAL STUDY METHODS........................................................................................................................ 37 
2.1. 
Analysis Groups .......................................................................................................................................... 37 
2.2. 
Dose Administration ................................................................................................................................... 37 
2.3. 
PK Sampling Schedule ................................................................................................................................ 37 
2.4. 
Analytical Methods ..................................................................................................................................... 38 
3. 
PHARMACOKINETIC ANALYSIS METHODS ................................................................................................... 39 
3.1. 
Analysis Population and Handling of Missing Time Points .............................................................................. 39 
3.2. 
Demographic and Baseline Characteristics.................................................................................................... 39 
3.3. 
Dosing and Pharmacokinetic Sampling Summary .......................................................................................... 39 
3.4. 
Definition and Estimation of Individual NCA PK Parameters ........................................................................... 40 
3.5. 
Descriptive Statistics ................................................................................................................................... 42 
4. 
LISTING OF PROPOSED TABLES, FIGURES, AND LISTINGS .......................................................................... 43 
 


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2. 
LIST OF ABBREVIATIONS 
 
 
Abbreviation  
Definition  
aCSR 
abbreviated Clinical Study Report 
ADAs  
anti-drug antibodies  
ADCC  
antibody-dependent cell mediated cytotoxicity  
AE  
adverse event  
BMI 
body mass index 
BOR 
best overall response 
C  
cycle  
CBR  
clinical benefit rate  
CDC  
complement dependent cytotoxicity  
CI 
Confidence interval 
CR  
complete response  
CT  
computed tomography  
D 
day 
DLT  
dose-limiting toxicity  
DOR  
duration of response  
ECG  
electrocardiogram  
ECOG  
Eastern Cooperative Oncology Group  
eCRF  
Electronic Case Report Form  
EOS 
End of Study 
ET 
Early Termination 
FFPE  
formalin fixed paraffin embedded  
HLA  
human leukocyte antigen  
IHC 
immunohistochemistry 
IV  
intravenous(ly)  
KIR  
killer cell immunoglobulin-like receptor  
mAb 
monoclonal antibody 
MedDRA  
Medical Dictionary for Regulatory Activities  
MRI  
magnetic resonance imaging  
MTD  
maximum tolerated dose  
NE 
non-evaluable 
NCI CTCAE  
National Cancer Institute Common Terminology Criteria for Adverse 
Events  
NK  
natural killer  
ORR  
objective response rate  
PD  
pharmacodynamics  
PD-L1  
programmed death – ligand 1  
PFS  
progression-free survival  
PK  
pharmacokinetics  
PR  
partial response  
PT 
Preferred term 
RECIST  
Response Evaluation Criteria in Solid Tumors  


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RP2D  
recommended phase II dose  
SAE  
serious adverse event  
SAP  
Statistical Analysis Plan  
SD 
Stable disease 
SOC 
System organ class 
SRC 
Safety review committee 
TEAE  
treatment-emergent adverse event  
TIL  
tumor infiltrating lymphocytes  


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3. 
 INTRODUCTION 
This Statistical Analysis Plan (SAP) covers the statistical analysis and reporting for the protocol 
OBI-888-001 final version 5.0 (dated 08 May 2020), and electronic case report form (eCRF) 
production version 5.4 dated 17 Nov 2020. 
The Sponsor elected to generate an abbreviated Clinical Study Report (aCSR) focusing on 
safety and exposure. 
4. 
STUDY OBJECTIVES 
4.1 
PRIMARY OBJECTIVES 
The primary objectives are:  
• 
To evaluate the safety and tolerability of OBI-888 when administered intravenously (IV) 
to patients with locally advanced or metastatic solid tumors. 
• 
To determine the maximum tolerated dose (MTD) and recommended phase II dose 
(RP2D) of OBI-888 as monotherapy. 
4.2 
SECONDARY OBJECTIVES 
The secondary objectives are:  
• 
To evaluate the preliminary clinical activity profile (objective response rate [ORR], clinical 
benefit rate [CBR], duration of response [DOR], and progression-free survival [PFS]) of 
OBI-888. 
• 
To evaluate the immunogenicity of OBI-888 (anti-drug antibodies [ADAs]). 
• 
To determine the serum pharmacokinetics (PK) and pharmacodynamics (PD) of 
OBI-888. 
4.3 
EXPLORATORY OBJECTIVES 
Exploratory objectives are:  
• 
To assess antibody-dependent cell mediated cytotoxicity (ADCC) and complement 
dependent cytotoxicity (CDC). 
• 
To identify potential predictive biomarkers.  
• 
To assess the expression of immune markers including immune checkpoints, in the 
tumor tissue samples.  
• 
To assess the expression of Globo H and related tumor-associated glycans in the tumor 
tissue. 
• 
To perform glycan analysis of OBI-888. 
5. 
STUDY DESCRIPTION 
5.1 
STUDY DESIGN 
This is a Phase I/II, open-label, dose escalation and cohort expansion study of OBI-888, a 
humanized monoclonal antibody (mAb) targeting Globo H, in patients with locally advanced or 
metastatic solid tumors.  


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This is a 2-part study. Part A (Dose Escalation) is designed to establish the MTD and RP2D of 
OBI-888. Part B (Cohort Expansion) is intended to further characterize the safety and clinical 
activity profile of the RP2D dose of OBI-888 administered as monotherapy in patients with locally 
advanced or metastatic solid tumors. 
5.1.1 PART A-DOSE ESCALATION 
The dose escalation part of the study included 3 cohorts of escalating dose levels of 5, 10, and 
20 mg/kg, using 3+3 design to identify MTD and RP2D.    
Three patients were enrolled at the lowest dose level. If none of the 3 patients experienced a 
dose-limiting toxicity (DLT), the next cohort of 3 patients were to be enrolled at the next higher 
dose level. If 1 of 3 patients in the initial dose cohort experienced a DLT, that cohort was expanded 
to 6 patients. If only 1 of these 6 patients had a DLT, then the next cohort of 3 patients were 
enrolled at the next higher dose level. If 2 or more patients of the 3-6 patients in a cohort 
experienced a DLT, dose escalation ceased and that dose level was above the MTD (the highest 
dose where no more than 1 of 6 patients had experienced at DLT). New patients were enrolled at 
the previous lower (tolerated) dose level until that cohort had 6 patients. This lower dose level was 
to be considered the MTD if ≤ 1 in 6 patients had a DLT. 
Patients should receive all four planned doses with OBI-888 administered during Cycle 1 to be 
eligible for DLT evaluation, unless they experienced a DLT with any dose. A patient who withdrew 
from the study within the DLT evaluation period for reasons other than drug-related adverse event 
(AE) was not included for DLT evaluation and was to be replaced; but could continue to receive 
study treatment after slipped dose, if still eligible for treatment.   
Escalation to higher OBI-888 dose cohort was not permissible during the study. After a DLT was 
experienced by patients, dose interruptions, modifications or dose delays may have applied, as 
per Investigators’ judgement (refer protocol section 8.3).  
5.1.2 PART B-COHORT EXPANSION 
At the time of this version of the SAP, Part A (Dose Escalation) was completed. No DLTs were 
observed at any dose level tested in Part A, and the MTD was not reached. Therefore, dosing in 
Part B was initiated at the highest dose tested in Part A (20 mg/kg OBI-888).   
Part B was planned to enroll a maximum of 150 additional patients with advanced solid tumors 
with high Globo H expression (defined as an H-score cutoff ≥ 100 using a validated 
immunohistochemistry [IHC] assay) across 4 disease-specific cohorts and 1 basket cohort based 
on a Simon two-stage design.  The first stage of Part B recruited up to 9 patients in each cohort 
(up to 45 patients in the first stage across all cohorts). If sufficient evidence of activity was 
observed in the first stage, up to 21 additional patients were to be enrolled into that cohort (up to 
105 patients in the second stage across all cohorts).    
Part B was conducted to obtain additional safety data, characterize the PK and PD profiles of OBI-
888, obtain a preliminary assessment of the clinical activity of OBI-888 in Globo H expressing 
solid tumors, and inform subsequent efficacy-finding clinical development.  
The following 5 cohorts of patients who had high expression of Globo H by a qualified laboratory 
assessment (i.e., Globo H H-score ≥ 100 using a validated IHC assay) were to  be enrolled in Part 
B.  
Cohort 1: Pancreatic cancer  
Cohort 2: Esophageal cancer  
Cohort 3: Gastric cancer  


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Cohort 4: Colorectal cancer  
Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4)  
All patients were required to provide a tumor biopsy sample, either unstained slides (preferred) or 
a formalin fixed paraffin embedded (FFPE) tissue block at the initiation of screening visit for 
screening for Globo H overexpression and confirmation for eligibility of patients for Part B. Patients 
with a confirmed and documented Globo H H-score of ≥ 100 were eligible for the study and were 
subsequently entered into the 28-day screening period to complete the remaining screening 
procedures.  
Patients were to continue to receive treatment with OBI-888 until progressive disease, 
unacceptable toxicity, or a decision by the Investigator or patient to discontinue treatment. 
5.2 
STUDY TREATMENT 
OBI-888 was administered as an IV infusion on Days 1, 8, 15, and 22 of each 28-day cycle in Part 
A and Part B of the study.   
For Part A (Dose Escalation), OBI-888 was given at doses of 5 mg/kg, 10 mg/kg and 20 mg/kg to 
the 3 dose cohorts. 
For Part B (Cohort Expansion), patients were to be treated with 20 mg/kg OBI-888 since no DLTs 
were observed at any dose level tested in Part A, and the MTD was not reached. 
Treatment was to continue until progressive disease, unacceptable toxicity, or a decision by the 
Investigator or patient to discontinue treatment.   
OBI-888 investigational drug solution (OBI-888 drug product mixed with saline/glucose infusion 
solution) was to be administered as an IV infusion by the site staff.  
The infusion was to be given for a duration of approximately 90-minutes (±10 minutes), for the 
initial two cycles (C1 and C2).  
The infusion duration from Cycle 3 could be reduced, if no infusion related AEs to prior infusions 
occurred, to 30 minutes or 60 minutes at the discretion of the Investigator.  
5.3 
SAFETY REVIEW COMMITTEE 
The Safety Review Committee (SRC) for OBI-888-001 study consisted of the clinical lead, medical 
monitor, and the study Investigator(s) or designee. The SRC was to act in an advisory capacity to 
monitor patient safety and efficacy during the trial. 
This Committee was to convene after each cohort completed the first cycle of treatment during 
the dose escalation phase, to review safety data (AEs and laboratory toxicities) to determine 
whether DLTs occurred. Based on DLTs in Part A with consideration of available PK and PD data, 
RP2D for Part B (Cohort Expansion) was to be recommended by SRC. The SRC was to convene 
at regular intervals during the conduct of the Cohort Expansion portion of the study to assess 
safety and activity. 
6. 
RANDOMIZATION AND BLINDING 
The study is a Phase I/II, open-label, dose escalation and cohort expansion study and did not 
involve randomization; patients and members of the clinical study team were not to be blinded to 
treatment. 


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7. 
SAMPLE SIZE AND POWER CALCULATION 
This was a 2-part study: Part A Dose Escalation and Part B Cohort Expansion.     
14 patients enrolled in the 3+3 dose escalation phase (Part A).   
The cohort expansion phase (Part B) was to enroll up to 150 total patients based on a Simon 
two-stage design. The first stage was to recruit up to 9 patients in each cohort. If at least 
1 objective response was observed within the first 6 cycles of therapy, a second stage recruitment 
was to occur with up to 21 additional patients enrolled into that cohort, for a total of up to 
30 patients per cohort. If at least 4 objective responses were observed within the first 6 cycles of 
therapy in 30 patients, then OBI-888 was considered worthy of further evaluation in that indication. 
This design is based on a level of low interest for a treatment with an ORR of 5% versus a level 
of high interest for a treatment with an ORR of 25%. The sample size was based on a one-sided 
alpha of 0.05 and 90% power. The two-stage design limits the number of patients treated for a 
treatment with low levels of activity. 
8. 
ANALYSIS ENDPOINTS 
 
Analysis endpoints are listed as per protocol. Only those endpoints marked with * will be 
analyzed in the aCSR. Exploratory analyses are to be conducted by OBI Translational Biology 
(or their designee) and may be included as appendices in the aCSR. 
8.1 
PRIMARY ENDPOINTS:   
• 
DLTs with OBI-888*. 
• 
AEs/ serious AEs (SAEs) and laboratory abnormalities as graded by National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03*. 
• 
MTD and RP2D of OBI-888. 
8.2 
SECONDARY ENDPOINTS:   
• 
Percentage of patients with ORR, CBR*, DOR and PFS according to Response 
Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 
• 
Percentage of patients with anti-OBI-888 ADAs in blood*. 
• 
PK and PD parameters of OBI-888*.  
8.3 
EXPLORATORY ENDPOINTS: 
• 
Globo H and related glycan expression in tumor tissue by IHC. 
• 
ADCC and CDC. 
• 
Identify potential predictive markers by IHC or molecular analysis. 
• 
Tumor Infiltrating Lymphocytes (TILs) including natural killer (NK) cells, and programmed 
death – ligand 1 (PD-L1) expression in tumor tissue samples by IHC. 
• 
Killer cell immunoglobulin-like receptor (KIR), human leukocyte antigen (HLA), and Fc 
receptor gamma genotype. 
• 
Glycan analysis of OBI-888. 
 


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9. 
ANALYSIS POPULATIONS 
Safety population: all enrolled patients who received at least 1 dose of study drug. This analysis 
set will be used for all endpoints and analyses except PK.  
PK population: all enrolled patients who received at least 1 dose of study drug and had sufficient 
PK samples (a sample at the end of administration and at least 3 samples during the elimination 
phase) will be included in the PK assessments. This analysis set will be used for all PK 
endpoints. 
10. 
ANALYTICAL PLAN AND STATISTICAL METHODS  
10.1 GENERAL CONVENTIONS AND STATISTICAL CONSIDERATIONS 
All statistical analyses will be conducted and data appendices will be created using the SAS 
system version 9.4 or higher. 
Data collected in this study will be presented in patient data listings and summary tables. 
Descriptive statistics (number of patients with non-missing values, mean, standard deviation, 
median, minimum, and maximum) will be presented for continuous variables. All raw data will be 
presented to the original number of decimal places. Means and medians will be presented to 
1 more decimal place than in the raw data. Standard deviations will be presented to 2 more 
decimal places than in the raw data. 
Frequency distributions (counts and percentages) will be presented for categorical variables. 
Discrete variables that are ordinal-scaled (e.g., ECOG performance score) will additionally be 
presented with mean scores and standard deviations. If not specified otherwise, the number of 
observations with non-missing values will be the denominator for percentage calculation. Further 
details on the handling of missing observations are presented in section 10.3.  
If days are converted to months, a factor of 30.4 days/month will be used. If days are converted 
to years, a factor of 365.25 days/year will be used. Time will be shown in study weeks, i.e. 
number of weeks from the first administration of any study drug. 
Dose escalation (Part A). The dose-escalation analysis will be presented by OBI-888 dose 
(5 mg/kg, 10 mg/kg or 20 mg/kg) cohorts and overall. The following cohorts and overall will be 
presented: 
• 
OBI-888 5 mg/kg 
• 
OBI-888 10 mg/kg 
• 
OBI-888 20 mg/kg 
• 
Dose Escalation Total 
Expansion cohorts (Part B). The expansion part analysis will be presented by cancer 
diagnosis. The following cohorts and overall will be presented: 
• 
Cohort 1: Pancreatic cancer 
• 
Cohort 2: Esophageal cancer 
• 
Cohort 3: Gastric cancer 
• 
Cohort 4: Colorectal cancer 
• 
Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4) 


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• 
Cohort Expansion Total 
10.2 DEFINITION OF BASELINE, STUDY VISITS, AND VISIT WINDOWS 
Baseline for each assessment is defined as the result of the last assessment prior to first dose 
of study drug. Per protocol, assessments performed at Day 1 should be obtained prior to 
infusion of the study drug. As only dates (without time) of assessments are recorded, the last 
assessment with a date prior to or the same as the first dose date will be considered baseline. 
The data will be analyzed according to the visits recorded in the eCRF. No additional visit 
windows will be applied. In listings, any unscheduled visits will be inserted in the appropriate 
temporal sequence using visit date and time. 
10.3 HANDLING OF MISSING DATA 
 
For the calculation of the time since initial cancer diagnosis, the following imputation rules will be 
applied when the date of initial cancer diagnosis is incomplete: 
• If the day is missing: first day of the month. 
• If the day and month are missing: first day of January. 
Partial or missing start and end dates of AEs and concomitant medications will be imputed 
conservatively based on the rule described in Appendix II: Imputation rules for missing dates. 
The imputed dates will be used to allocate the AEs and concomitant medications to a study 
period, and to determine whether an AE is/is not treatment emergent. Listings of the AEs and 
concomitant medications will present the actual partial dates; imputed dates will not be shown. 
For CBR endpoint, patients with missing data (for any reason) will be included as non-
responder. 
10.4 PATIENT DISPOSITION 
Patients in each analysis population, as well as patients who complete the treatment, complete 
the study, and patients who prematurely discontinue from treatment and from the study, together 
the with number of enrolled patients will be tabulated as indicated in section 10.1. The number 
and percentage within each category will be presented.   
The number and percentage of patients included in the safety and PK populations will also be 
summarized by study part, and cohort (and for Phase B).   
A listing with all enrolled patients will be generated for the study to describe country/study 
center, patient number, study part, cohort, first and last study drug dosing dates, total duration of 
study drug dosing, the reason for discontinuing study drug dosing, end of study date, and 
reason for discontinuing the study. 
10.5 PROTOCOL DEVIATIONS 
Protocol deviations and their classification (minor/major) will not be summarized. 
Protocol deviations will be classified as major and minor as specified in the Protocol Deviations 
Management Plan. Patients with major protocol deviation will be identified and documented 
before the database lock. 


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10.6 PATIENT CHARACTERISTICS 
Patient characteristics will be summarized for safety population. 
10.6.1 BASELINE AND DEMOGRAPHIC CHARACTERISTICS 
Descriptive statistics for continuous variables (age at screening, height, weight at baseline, and 
BMI [body mass index]) and frequency counts and percentages for categorical demographic 
variables (gender, ethnicity, race, Globo-H score, and Eastern Cooperative Oncology Group 
[ECOG]) performance will be summarized by study part, and cohort using the safety population.   
BMI will be derived as: BMI [kg/m2] =weight[kg]/(height[cm]/100)2. 
 
Height reported in inches will be converted to centimeters as: height [cm] = height [in] * 2.54. 
 
Demographic and baseline characteristics will be provided in a listing. 
10.6.2 CANCER DIAGNOSIS HISTORY 
Part A 
Time since initial diagnosis (months), tumor size at first diagnosis (mm), tumor type and location, 
TNM stage of disease at diagnosis and at study entry, presence and location of metastasis, 
most recent treatment prior to screening, TNM classification at study entry will be tabulated. 
Descriptive statistics will be used to describe tumor size at first diagnosis. Data will be 
summarized in the safety population by dose and overall.  
Colorectal cancer history, pancreatic cancer history, and gastric/gastroesophageal junction or 
esophageal cancers history will not be summarized separately. 
Part B 
In patients who have cancer history to be reported, stage of disease at diagnosis, time since 
initial diagnosis (months), metastasis (yes/no), and sites of metastases (liver, peritoneum, lung, 
bone, regional lymph nodes, other) will be tabulated. Descriptive statistics will be used to 
describe the number metastases’ sites. 
Cancer diagnosis history will be listed.  
10.6.3 OTHER PATIENT CHARACTERISTICS 
Following patient characteristics will be listed: 
• 
Medical history and current medical conditions 
• 
Prior and concomitant medications 
• 
Prior anticancer therapy 
• 
Smoking history  
10.7 ANALYSIS OF STUDY ENDPOINTS 
This section describes analysis of primary, secondary and exploratory endpoints. All endpoints 
will be analyzed using planned treatments. Summaries will be presented for safety population. 


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10.7.1 PRIMARY ENDPOINTS 
 
A. DLTs with OBI-888 
The period for DLT is 28 days from the start of first dose of Investigational Product at Day 1 in 
study part A.   
A DLT is defined as the occurrence of any of the following events within the first cycle of 
treatment and are considered to be at least possibly related to OBI-888: 
• 
  Grade 4 neutropenia 
• 
  Grade ≥ 3 febrile neutropenia with or without infection 
• 
  Grade 4 thrombocytopenia 
• 
  Grade ≥ 3 nausea and vomiting or diarrhea for more than 72 hours despite optimal 
supportive care 
• 
  Any Grade ≥ 3 non-hematological AE, except for nausea, vomiting, or diarrhea that 
does not resolve before the next infusion 
• 
 Grade 4 infusion reactions, and Grade ≥ 3 infusion reactions that recur despite 
decreasing infusion rate and optimal supportive care measures 
DLTs will be displayed by assigned dose and cohort in a frequency table in decreasing order of 
incidence. DLTs will not be programmatically derived but analyzed as collected on the eCRF. 
AE terms will be coded using the most current version of the Medical Dictionary for Regulatory 
Activities (MedDRA). AEs will be graded according to the NCI CTCAE version 4.03. All AEs 
unless they have been determined to be not related to study drug will be taken into 
consideration in determining DLTs.   
B. AEs/SAEs and laboratory abnormalities as graded by NCI CTCAE version 4.03 
A treatment-emergent adverse event (TEAE) is defined as an AE with onset dates on or after 
the start of study drug or if it is present prior to receipt of the study treatment but worsens in 
severity or increases in frequency on or after the first dose. AEs having both onset and end 
dates missing will be considered as TEAEs. 
Events reported as “Unrelated” or “Unlikely related” to study drug will be considered as 
unrelated to the study drug. Events reported as “Possibly related”, “Probably related”, “Definitely 
related” to study drug or without relationship information will be considered as related to the 
treatment. 
Tables will display the incidence of events (number of events, number of patients with any 
event, number of patients with any event in each specific system organ class [SOC], and number 
of patients with any event for each specific preferred term [PT]). 
For each AE, only the highest grade and closest association with study drug by patient will be 
considered in the incidence analyses. 
The following tables will be produced: 
Tables by SOC and PT will be displayed for following AEs. Only those AEs marked with * will be 


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analyzed in the aCSR: 
• 
DLTs 
• 
Treatment-emergent adverse events (TEAEs)* 
• 
TEAEs grade ≥ 3* 
• 
TEAEs related to OBI-888* 
• 
TEAEs leading to discontinuation of OBI-888* 
• 
Serious TEAEs 
• 
Serious TEAEs related to OBI-888* 
• 
AEs leading to discontinuation of OBI-888 
• 
SAEs leading to discontinuation of OBI-888 
• 
TEAEs leading to death* 
A table of TEAEs by SOC, PT and worst CTCAE grade (per summarization level) will be 
presented. 
The following listings will be prepared:  
• 
All AEs, with DLTs flagged 
• 
All SAEs 
• 
AEs related to OBI-888 
• 
AEs grade ≥ 3 
• 
All TEAEs leading to OBI-888 discontinuation 
• 
AEs leading to death 
 
C. MTD and RP2D of OBI-888 
The MTD and RP2D were identified as 20 mg/kg during SRC review.   
10.7.2 SECONDARY ENDPOINTS 
 
A. Percentage of patients with CBR according to RECIST 1.1 
CBR: Defined as the proportion of patients with confirmed complete response (CR), partial 
response (PR) or stable disease (SD) among all the treated patients (including non-evaluable 
[NE] ones). A confirmed response will be defined as two or more consecutive assessments 
separated by at least 3 weeks. The 95% confidence interval (CI) will be estimated using the 
exact binomial distribution. The CBR summary table will be supported by the overall tumor 
response listing. 
If an NE response is determined at a time point, this response will be ignored and subsequent 
non-NE response will be used for the confirmation. For example, the sequence of tumor 
assessments: PR, NE, NE, CR, SD, that had more than one consecutive NE, the third 
subsequent non-NE response (CR) is used as the confirmation of the first PR for best overall 
response derivation. 
A requirement for SD is that it should be met at least once ≥ 6 weeks after the first dose of trial 
treatment, otherwise the best response will be NE.  
The criterion for confirmation of the response is summarized in the following table (Eisenhauer 
et al, 2009): 


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Overall response 
first time point 
Overall response 
subsequent time 
point 
Best overall response 
CR 
CR 
CR 
CR 
PR 
SD, PD or PR [1] 
CR 
SD 
SD provided minimum criteria for SD duration met, 
otherwise PD 
CR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise PD  
CR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise NE 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD 
PR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise PD 
PR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise NE 
NE 
NE 
NE 
[1] If a CR is truly met at first timepoint, then any disease seen at a subsequent timepoint, even disease meeting PR criteria relative 
to baseline, makes the disease PD at that point (since disease must have re-appeared after CR). Best response would depend on 
whether minimum duration of SD was met. However, sometimes ‘CR’ may be claimed when subsequent scans suggest small lesions 
were likely still present and in fact the patient had PR, not CR at the first timepoint. Under these circumstances, the original CR should 
be changed to a PR and the best response is PR. 
Overall tumor response (not to be programmatically derived and collected on eCRF) will be 
listed by assigned dose, cohort, and visit.    
B. Percentage of patients with ADAs in blood 
 
The number and percentage of patients with positive ADAs in the blood will be summarized for 
the safety population. 
C. PK and PD parameters of OBI-888  
Pharmacokinetic Analysis 
PK and PD analyses will be conducted by OBI Pharma, Inc. Please refer to statistical analysis 
plan developed for PK and PD parameters (Appendix III). 
10.7.3 EXPLORATORY ENDPOINTS 
 
• 
Globo H and related glycan expression in tumor tissue by IHC 
• 
ADCC and CDC 
• 
Identify potential predictive markers by IHC or molecular analysis 
• 
TILs, including NK cells, and 
PD-L1 expression in tumor tissue samples by IHC 


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• 
KIR, HLA, and Fc receptor gamma genotype 
• 
Glycan analysis of OBI-888 
The above analyses will be conducted by OBI Translational Biology (or their designee). Details of 
these analyses will be provided in separate document(s). The results will be compiled into a 
separate appendix in Section 14 of the aCSR. 
10.8 SAFETY ENDPOINTS 
This section describes the safety endpoints that are not part of the primary, secondary, or 
exploratory endpoints previously described in section 10.7.   
All safety endpoints will be analyzed using the safety population based on treatments the patients 
actually received during the study. 
Safety will be evaluated by presenting summaries of exposure to study treatment, laboratory 
evaluations (hematology, chemistry, coagulation, and urine analysis), vital signs, and other 
parameters. 
10.8.1 EXPOSURE TO STUDY TREATMENT 
The number of doses received, actual dose received in mg, the total planned dose in mg/kg and 
the extent of exposure, (calculated as last dose date - first dose date +1), will be summarized 
using descriptive statistics by cohort, study part and overall. 
A by-patient listing with the treatment administration data will be also presented and reasons for 
doses missed will be also listed.  
10.8.2 LABORATORY DATA 
Tables by visit and by NCI CTC grades (grade 0, grade 1, grade 2, grade 3, grade 4, grade 5) 
will be presented by laboratory test, where applicable. Worst-post baseline NCI CTC grade for 
applicable laboratory tests will be also summarized. 
Urinalysis results (normal/ abnormal – low/ abnormal - high) will be summarized by visit. 
Data listings will be produced for all collected laboratory data, including pregnancy test results. 
10.8.3 VITAL SIGNS  
Vital signs assessments (temperature, pulse, systolic and diastolic blood pressure) and weight 
will be tabulated by visit (results and changes from baseline). 
Data listings will be produced for all collected vital signs data.  
10.8.4 ELECTROCARDIOGRAM 
Data listings for electrocardiogram (ECG) data will be produced. 
10.8.5 OTHER SAFETY PARAMETERS 
ECOG will not be summarized. 
Physical examination results (normal/abnormal-not clinically significant/abnormal-clinically 


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significant) will be summarized by visit and listed. 
11. 
DEVIATIONS FROM ANALYSIS AS DESCRIBED IN THE 
PROTOCOL 
The Sponsor elected to generate an aCSR focusing on safety and exposure. As a result, the 
following analyses will not be conducted: DOR, best overall response (BOR), PFS, ORR. 
Protocol deviations will not be summarized nor listed. Medical history, current medical 
conditions, prior and concomitant medications, prior anticancer therapy, and smoking history will 
be summarized in the listings only. Serious TEAEs and SAEs leading to discontinuation of OBI-
888 will not be summarized. Shift tables of the worst on study laboratory toxicity based on NCI 
CTCAE grading will not be presented; summaries of laboratory data (with exception of summary 
described in section 10.8.2), and ECOG over time will not be presented.  
DLT criteria as collected on eCRF will be analysed.  
12. 
LIST OF TABLES, LISTINGS, AND FIGURES 
Shells for unique tables, listings and figures are provided in a separate Mock-Up tables, figures, 
and listings (TFLs) document. 
13. 
REFERENCES 
Patrick Therasse, Susan G. Arbuck, Elizabeth A. Eisenhauer, et al. New Guidelines to Evaluate 
the Response to Treatment in Solid Tumors Journal of the National Cancer Institute, Vol. 92, 
No. 3, February 2, 2000. 


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14. 
APPENDIX I. SCHEDULE OF ASSESSMENTS 
TABLE 14-1  SCHEDULE OF ASSESSMENTS  
Schedule of Assessments 
Study Procedure 
Screenin
g Visit** 
Treatment Period 
EoS 
/ ET 
Cycle (C) # 
- 
Cycle 1 
Cycle 2-13 
 
Cycle # and Day  
 
C1D
1 
C1D
8 
C1D1
5 
C1D
22 
 
 
Window period 
(days)  
-28 to -1 
days 
-1* ±1 
±3 ±3 
±3 days 
±7 
days 
Informed consenta 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Eligibility screening 
X 
X 
 
 
 
 
 
Medical historyb 
X 
X 
 
 
 
 
 
Physical 
examinationc 
X 
X 
X 
X 
X 
X 
X 
Height, weightd 
X 
X 
X 
X 
X 
X 
X 
Vital signse 
X 
X 
X 
X 
X 
X 
X 
ECOGf 
X 
 
 
 
 
C2D1 only 
X 
12-lead ECGg 
X 
X 
X 
 
 
C2D1 only 
X 
Pregnancy testingh 
X 
 
 
 
 
 
X 
Tumor biopsyi 
X** 
 
 
 
 
 
 
Hematology and 
Biochemistry j  
X 
X 
X 
X 
X 
Every 2 weeks (D1 and 
D15 of each Cycle) 
X 
Coagulation and 
Urinalysisk 
X 
X 
 
 
 
Every 2 cycles, D1 (C2 
C4, C6, C8, C10, C12) 
X 
Drug administrationl 
 
X 
X 
X 
X 
D1, D8, D15, D22 of each 
28 day cycle 
 
Pharmacokinetic 
samplem 
 
See footnote m and Table 14-2 (Part A) and Table 14-3 
(Part B) 
Immunogenicity 
(ADA)n 
 
See footnote n and Table 14-2 (Part A) and Table 14-3 
(Part B) 
Biomarkerso 
X 
See footnote o and Table 14-2 (Part A) and Table 14-3 
(Part B) 
Radiology 
evaluations (CT or 
MRI)p 
X 
 
 
 
 
End of every 2 cycles 
X 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
EOS/ET - End of Study/Early Termination. EoS Visit is the safety follow-up visit, conducted 


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28±7 days after the last OBI-888 dose. ET visit lab assessments will be conducted for 
patients discontinuing study treatment, if last available tests are before 2 weeks.  
*The - 1 day window (1 day prior) for C1D1 is for safety laboratory assessments. Blood can 
be drawn 1 day prior to initiation of study drug infusion on C1D1. Safety laboratory results 
should be available and reviewed by the Investigator prior to the OBI-888 administration. 
** All patients are required to provide a tumor biopsy sample, unstained slides (preferred) or 
a FFPE tissue block at the initiation of screening visit for screening of Globo H overexpression 
and confirmation for eligibility of patients for Part B. Patients with a confirmed and 
documented Globo H H-score of ≥ 100 are eligible for the study, and will subsequently enter 
the 28-day screening period to complete the remaining screening procedures. 
Footnotes:  
a. Informed consent to be obtained before any other study procedures are performed. 
b. Medical history to include previous cancer therapies, cancer history, and past and 
ongoing concomitant illnesses. 
c. A complete physical examination is required at screening and at discontinuation. 
Directed physical examinations may be limited to problem focused review of symptoms 
and major organ systems  
d. Height to be obtained at screening only. 
e. Vital signs include temperature, blood pressure and pulse (at supine position). 
Temperature measurement will be obtained as clinically indicated. 
f. 
ECOG performance status: at baseline, C2D1 and end of study/early termination  
g. 12-lead ECG: at screening and post infusion at C1D1, C1D8, and C2D1 (within one 
hour after end of infusion); and end of study/ early termination 
h. Pregnancy testing should be performed in females of childbearing potential only. A 
serum pregnancy test is required during screening. A urine or serum pregnancy test is 
acceptable end of study or early termination 
i. 
Tumor biopsy samples are mandatory at screening visit. Fresh (preferred) tissue or 
archival tissue is acceptable. A minimum of 3 slides are required for the central 
laboratory Globo H assay for determination of eligibility. Up to 12 unstained additional 
slides should be provided, depending upon availability, for the protocol-defined 
exploratory studies. 
j. 
Hematology and Serum chemistry (Laboratory Assessments: Protocol Table 12-1). 
Blood draw is prior to OBI-888 infusion.  
Hematology: hematocrit, hemoglobin, erythrocyte count, white blood count (WBC), 
absolute counts of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, 
basophils, and platelet count. Serum chemistry: sodium, potassium, chloride, 
bicarbonate, BUN, creatinine, glucose, calcium, phosphorus, magnesium, total protein, 
albumin, ALT, AST, ALP, creatine kinase, LDH, total bilirubin, and uric acid. Creatinine 
clearance will be calculated by Cockcroft Gault equation at screen visit, week 1 and 
EOS/early termination.  
k. Coagulation, and Urinalysis (Laboratory Assessments: Protocol Table 12-1) Blood draw 
and urine collection is prior to OBI-888 infusion. 
Coagulation: PT, aPPT, and INR. Urinalysis: specific gravity, pH, protein, glucose, 
ketones, bilirubin, urobilinogen, blood, nitrite, leukocyte esterase as assessed by 
dipstick. A microscopic urinalysis (only if needed) evaluating white blood cells, red 
blood cells, epithelial cells, bacteria, cast and crystals 
l. 
OBI-888 is given in cycles with each individual cycle consisting of 28 days (4-week 
cycle). IP is administered on weekly basis (within cycle as C1D1, C1D8, C1D15, and 


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C1D22; C2D1, C2D8, and so on; for a total of 13 cycles, or disease progression or 
unacceptable toxicity, whichever occurs earlier. 
m. Pharmacokinetic: (for analysis of serum concentration of OBI-888). Detailed schedules 
are provided in Table 13-2 (Part A) and Table 13-3 (Part B). 
n. Immunogenicity studies (ADA) - ADA samples will be collected at the same time points, 
along with pre-infusion only PK samples. No post-infusion ADA samples will be 
collected. Detailed schedules are provided in Table 13-2 (Part A) and Table 13-3 (Part 
B). For patients with persistent antibodies at end of study, an additional ADA sample 
will be collected at 4 months after the end of study visit. 
o. Biomarker: Detailed schedules are provided in Table 13-2 (Part A) and Table 13-3 
(Part B). 
p. Radiology (CT or MRI scan) evaluations of tumor response: Performed during screening 
and during the study at the end of every second cycle (8 weeks) at: C2, C4, C6, C8, 
C10 and C12. CT or MRI scan will be performed within 1 week prior to the start of the 
next cycle. Unscheduled scan can be perform anytime, if needed to confirm disease 
progression. Radiology assessment for early termination/end of study, should only be 
performed if 8 or more than 8 weeks (≥8 weeks) have passed from the previous 
scheduled CT/MRI scan. Same assessment method and same technique should be used 
on each patient while on study.  
 
 
 


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TABLE 14-2  PART A – PHARMACOKINETIC, ADA, BIOMARKER, AND GLYCAN 
SAMPLING SCHEDULE  
Cycle (C) 
Cycle 1 
Cycle 2 
Ever
y 
2 Cy
clese, 
h 
EoS / 
ET 
Cycle Day 
D1 
D2 
D4 D8 D15 D2
2 
D1, 
8, 15 
D22 
D1 
±7 
days 
Pharmacokinetic 
Samples 
 
 
 
 
 
 
 
 
 
 
  Before infusion 
Xa 
 
 
Xb 
Xb 
Xb 
Xb 
Xb 
Xb 
X 
  End of infusion (90 
minutes)c 
X 
Xd 
Xd 
X 
X 
X 
X 
X 
 
 
  1 hour after end of 
infusion (150 minutes)e 
X 
 
 
 
 
 
 
 
  4 hours after end of 
infusion (330 minutes)e  
X 
 
 
 
 
 
 
 
 
 
  8 hours after end of 
infusion (570 minutes)e 
X 
 
 
 
 
 
 
 
 
 
Immunogenicity 
studies (ADA)f 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Glycan analysisg 
X 
 
 
X 
X 
X 
X 
X 
 
 
Biomarkers 
 
 
 
 
 
 
 
 
 
 
  ADCCi 
X 
 
 
 
X 
 
 
X 
C4D1 
X 
  CDC/ADCCi 
X 
 
 
X 
X 
 
 
 
 
 
  KIR, HLA, Fc receptor 
gamma genotypingi 
X 
 
 
 
 
 
 
 
 
X 
ADA = antidrug antibody; ADCC = antibody-dependent cell-mediated cytotoxicity; C = cycle; 
CDC = complement dependent cytotoxicity; D = day; EoS/ET = End of Study/Early 
Termination; HLA = human leukocyte antigen; KIR = killer cell immunoglobulin-like receptor 
Note: OBI-888 infusion should be administered on Days 1, 8, 15, and 22 of every 28-day 
cycle throughout the study treatment period.  
The infusion duration of Cycle 1 and Cycle 2 are 90 minutes, and can be reduced to 30-60 
minutes for Cycle 3, if there were no infusion related adverse events on prior infusions and at 
the discretion of the investigator. 
a. 
C1D1 Pre-infusion serum samples can be drawn within 1 day prior-to the infusion. 
b. 
Pre-infusion serum samples can be collected at any time prior to the infusion on the day 
of the infusion. 
c. 
Post infusion samples at the end of infusion and later (at 1, 4, and 8 hours after the end 
of the infusion) can be collected in a window of ±15 minutes. 
d. 
For Cycle1 Days 2 and 4, a single sample will be collected (window ±2 hours):  
 
24 hours after end of infusion (for infusion at C1D1) 


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 
72 hours after end of infusion (for infusion at C1D1) 
e. 
If there is change of the infusion rate or interruption of infusion, the PK sampling at Day 
1 are to be collected from the exact time of completion of infusion to obtain the post-
infusion samples at 1, 4, 8 hour at the end of infusion. Exact time of sample collection 
and the reason for interruption should be documented in the eCRF. 
f. 
ADA sample will be collected along with the pre-infusion PK samples according to the 
above table. No post-infusion ADA samples including C1D2 and C1D4 will be collected. 
For patients with persistent antibodies at end of study, an additional ADA sample will be 
collected at 4 months after the end of study visit. 
g. 
Glycan analysis: pre-infusion and end of infusion in cycle 1 and 2 only. Residual PK and 
ADA samples will be pooled for glycan analysis after PK and ADA data are finalized. 
h. 
Samples to be collected on Day 1 of C4, C6, C8, C10, C12. 
i. 
Biomarkers:  
• 
ADCC (effector cell): pre-infusion blood sample will be collected at C1D1, C1D15,
C2D22, C4D1 and end of study/early termination.  
• 
CDC/ADCC (humoral): pre infusion and end-of-infusion blood sample will be collected
at C1D1, C1D8, and C1D15. 
• 
KIR, HLA, Fc receptor gamma genotyping: blood sample will be collected at C1D1 
(pre-infusion) and end of study/early termination. 
  
 
 


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TABLE 14-3  PART B – PHARMACOKINETIC, ADA, AND BIOMARKER SAMPLING 
SCHEDULE   
 
Cycle (C) 
Scree
ning 
Cycle 1 
Cy
cle 
2 
Every 
2 
cycle
s 
starti
ng 
with 
Cycle
 3 a 
Every 
2 cycl
es 
starti
ng 
with 
Cycle
 4c 
EoS / 
ET 
Cycle Day 
-28 
to -1 
days 
D
1 
D2 D4 
D
8 
D
1
5 
D2
2 
D1 
D1 
D1 
±7 
days 
Pharmacokinetic 
Samples 
 
 
 
 
 
 
 
 
 
 
 
  Before infusion 
 
Xd 
 
 
Xb 
Xb 
 
Xb 
 
Xb 
 
  End of infusion (90 
minutes)f 
 
X 
Xj,k 
Xk 
 
X 
 
 
 
 
 
  1 hour after end of 
infusion  
  (150 minutes)e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
  3 hours after end of 
infusion  
  (270 minutes) e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
  6 hours after end of 
infusion  
  (450 minutes) e,f 
 
Xj 
 
 
 
 
 
 
 
 
 
Immunogenicity 
studies (ADA)g 
 
X 
 
 
 
 
 
X 
 
X 
X 
Glycan analysish 
 
X 
 
 
X 
X 
 
X 
 
X 
X 
Biomarkers 
 
 
 
 
 
 
 
 
 
 
 
  Globo H 
X 
 
 
 
 
 
 
 
 
 
 
  ADCC/CDC 
(humoral)d,l 
 
X 
 
 
X 
X 
 
 
 
 
 
  KIR, 
HLA, 
Fc 
receptor 
gamma 
genotypingd 
 
X 
 
 
 
 
 
 
 
 
 
  Multiplex IHCn 
X 
 
 
 
 
 
 
 
 
 
 
  Diagnostic markern 
X 
 
 
 
 
 
 
 
 
 
 


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  SSEA-3/SSEA-4n 
X 
 
 
 
 
 
 
 
 
 
 
  Surrogate 
biomarkerd,i 
 
X 
 
 
 
 
 
 
X 
 
 
ADA = antidrug antibody; ADCC = antibody-dependent cell-mediated cytotoxicity; C = cycle; 
CDC = complement dependent cytotoxicity; D = day; EoS/ET = End of Study/Early 
Termination; HLA = human leukocyte antigen; IHC = immunohistochemistry; KIR = killer cell 
immunoglobulin-like receptor; SSEA = stage-specific embryonic antigens 
Note:  OBI-888 infusion should be administered on Days 1, 8, 15, and 22 of every 28 day 
cycle throughout the study treatment period.  
The infusion duration of Cycle 1 and Cycle 2 are 90 minutes, and can be reduced to 30-60 
minutes from Cycle 3, if there were no infusion related adverse events on prior infusions and 
at the discretion of the investigator. 
a. 
Samples to be collected on Day 1 of C3, C5, C7, C9, C11, and C13. 
b. 
Pre-infusion serum samples can be collected at any time prior to the infusion on the day 
of the infusion. 
c. 
Samples to be collected on Day 1 of C4, C6, C8, C10, and C12. 
d. 
C1D1 Pre-infusion serum samples can be drawn within 1 day prior-to the infusion. 
e. 
If there is change of the infusion rate or interruption of infusion, the PK sampling at Day 
1 are to be collected from the exact time of completion of infusion to obtain the post-
infusion samples at 1, 3, 6 hour at the end of infusion. Exact time of sample collection 
and the reason for interruption should be documented in the eCRF. 
f. 
Post infusion samples at the end of infusion and later (at 1, 3, and 6 hours after the end 
of the infusion) can be collected in a window of ±15 minutes 
g. 
ADA sample will be collected along with the pre-infusion PK samples according to the 
above table. For patients with persistent antibodies at end of study, an additional ADA 
sample will be collected at 4 months after the end of study visit. 
h. 
Glycan analysis: Residual PK and ADA samples will be pooled for glycan analysis after PK 
and ADA data are finalized. 
i. 
Samples should be collected to evaluate tumor-specific biomarkers (eg, CEA for 
colorectal, gastric, and esophageal cancer; and CA19-9 for pancreatic cancer).  
j. 
This intensive PK sampling will be collected only from first 3 patients in each cohort.  
k. 
For C1D2 and C1D4, samples can be collected in a window of ±2 hours: 
• 
24 hours after end of infusion (for infusion at C1D1). 
• 
72 hours after end of infusion (for infusion at C1D1). 
l. 
Blood sample will be collected pre-infusion and end-of-infusion. 
m. 
Blood sample will be collected pre-infusion. 
n. 
Tumor biopsy samples obtained during the initial screening visit should be used for this 
assessment. 


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15. 
APPENDIX II 
IMPUTATION RULES FOR MISSING DATES 
  
Algorithm for Treatment-emergent Adverse Events  
AE Start Date  
AE Stop Date  
Action   
Known  
Known  
If start date < study drug start date, then not TEAE  
If start date ≥ study drug start date, then TEAE  
Partial  
If start date < study drug start date, then not TEAE  
If start date ≥ study drug start date, then TEAE  
Missing or  
Unknown  
If start date < study drug start date, then not TEAE  
If start date ≥ study drug start date, then TEAE  
Partial, but the known 
date components show 
that it cannot be on or 
after study drug start 
date  
Known  
Not TEAE  
Partial  
Not TEAE  
Missing or  
Unknown  
Not TEAE  
Partial, could be on or 
after study drug start 
date  
 
Known  
If stop date < study drug start date, then not TEAE  
If stop date ≥ study drug start date, then TEAE  
Partial  
Impute stop date as latest possible date (i.e., last day of 
month if day is unknown or 31-Dec if day and month are 
unknown), then:  
If stop date < study drug start date, then not TEAE  
If stop date ≥ study drug start date, then TEAE  
Missing or  
Unknown  
Assumed TEAE  
Missing or  
Unknown  
Known  
If stop date < study drug start date, then not TEAE  
If stop date ≥ study drug start date, then TEAE  
Partial  
Impute stop date as latest possible date (i.e., last day of 
month if day is unknown or 31st December if day and month 
are unknown), then:  
If stop date < study drug start date, then not TEAE  
If stop date ≥ study drug start date, then TEAE  
Missing or  
Unknown  
Assumed TEAE  
 
 
 


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Algorithm for Concomitant Medications  
CM Start Date  
CM Stop Date  
Action   
Known  
Known  
If stop date < study drug start date, assign as PRIOR   
If stop date ≥ study drug start date, assign as CONCOMITANT  
Partial  
Impute stop date as latest possible date (i.e., last day of month if 
day unknown or 31-Dec if day and month are unknown), then:  
If stop date < study drug start date, assign as PRIOR  
If stop date ≥ study drug start date, assign as CONCOMITANT  
Missing or  
Unknown  
Assign as CONCOMITANT  
Partial  
Known  
If stop date < study drug start date, assign as PRIOR  
If stop date ≥ study drug start date, assign as CONCOMITANT  
Partial  
Impute stop date as latest possible date (i.e., last day of month if 
day unknown or 31-Dec if day and month are unknown), then:  
If stop date < study drug start date, assign as PRIOR  
If stop date ≥ study drug start date, assign as CONCOMITANT  
Missing or  
Unknown  
Assign as CONCOMITANT  
Missing or  
Unknown  
Known  
If stop date < study drug start date, assign as PRIOR  
If stop date ≥ study drug start date, assign as CONCOMITANT  
Partial  
Impute stop date as latest possible date (i.e., last day of month if 
day unknown or 31-Dec if day and month are unknown), then:  
If stop date < study drug start date, assign as PRIOR  
If stop date ≥ study drug start date, assign as CONCOMITANT  
Missing or  
Unknown  
Assign as CONCOMITANT  


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16. 
APPENDIX III. PHARMACOKINETIC ANALYSIS PLAN 
 
 
PHARMACOKINETIC ANALYSIS PLAN 
 
A PHASE I, OPEN-LABEL, DOSE ESCALATION AND COHORT 
EXPANSION STUDY EVALUATING THE SAFETY, 
PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD), AND 
THERAPEUTIC ACTIVITY OF OBI-888 IN PATIENTS WITH 
LOCALLY ADVANCED OR METASTATIC SOLID TUMORS 
 
 
VERSION 1.0 
DATE: 29 JAN 2021 
 
 
 
 
Property of OBI Pharma, Inc. 
Confidential 
May not be used, divulged, published or otherwise disclosed 
without the consent of OBI 
 
 


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PHARMACOKINETIC ANALYSIS PLAN SIGNATURE PAGE 
Pharmacokinetic Analysis Plan V1.0 (Dated 29JAN2021) for Protocol OBI-888-001. 
 
 
Name 
Signature 
Date 
Author: 
 
 
DDMMMYYYY 
 
Position: 
 
 
Company: 
 
 
Upon review of this document, the undersigned approves this version of the Statistical Analysis Plan, 
authorizing that the content is acceptable for the reporting of this study. 
 
Name 
Signature 
Date 
Approved By: 
 
 
DDMMMYYYY 
 
Position: 
 
 
Company: 
 
 
Approved By: 
 
 
DDMMMYYYY 
 
Position: 
 
 
Company: 
 
 
Approved By: 
 
 
DDMMMYYYY 
 
Position: 
 
 
Company: 
 


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MODIFICATION HISTORY 
 
Unique 
Identifier for 
this Version 
Date of the 
Document 
Version 
Author 
Significant Changes from  
Previous Authorized Version 
1.0 
29Jan2021 
 
Not Applicable – First Version 
 
 


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TABLE OF CONTENTS 
1. 
INTRODUCTION ..........................................................................................................................................37 
2. 
CLINICAL STUDY METHODS ........................................................................................................................37 
2.1. 
Analysis Groups.......................................................................................................................................... 37 
2.2. 
Dose Administration ................................................................................................................................... 37 
2.3. 
PK Sampling Schedule ................................................................................................................................ 37 
2.4. 
Analytical Methods ..................................................................................................................................... 38 
3. 
PHARMACOKINETIC ANALYSIS METHODS ..................................................................................................39 
3.1. 
Analysis Population and Handling of Missing Time Points .............................................................................. 39 
3.2. 
Demographic and Baseline Characteristics ................................................................................................... 39 
3.3. 
Dosing and Pharmacokinetic Sampling Summary .......................................................................................... 39 
3.4. 
Definition and Estimation of Individual NCA PK Parameters ........................................................................... 40 
3.5. 
Descriptive Statistics ................................................................................................................................... 42 
4. 
LISTING OF PROPOSED TABLES, FIGURES, AND LISTINGS ........................................................................43 
 
 


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ACRONYMS AND ABBREVIATIONS 
Standard acronyms and abbreviations are listed below. 
 
Abbreviation  
Definition 
AUC  
Area Under the Concentration-Time Curve 
AUC(0-last)  
AUC to the Last Measurable Concentration 
AUC(0-t)  
AUC from 0 to time t 
AUC(0-∞)  
AUC Extrapolated to Infinity 
BMI  
Body Mass Index 
BQL  
Below the Quantification Limit 
Clast  
Last Measurable Concentration (above the quantification limit) 
CL 
Clearance 
cm  
Centimeter(s) 
Cmax  
Maximum Serum Concentration 
CSR  
Clinical Study Report 
CV  
Coefficient of Variation 
EDC  
Electronic Data Capture 
g  
Gram(s) 
GM  
Geometric Mean 
GSD  
Geometric Standard Deviation 
h  
Hour(s) 
Ke  
Terminal Phase Elimination Rate Constant 
kg  
Kilogram(s) 
L  
Liter(s) 
LLOQ  
Lower Limit of Quantification 
Max  
Maximum 
Min  
Minimum 
min  
Minute(s) 
mL  
Milliliter(s) 
NCA  
Noncompartmental Analysis 
µg  
Microgram(s) 
PK  
Pharmacokinetic(s) 
SD  
Standard Deviation 
t1/2  
Apparent Terminal Elimination Half-Life 
Tlast  
Time of Last Measurable Concentration 
Tmax  
Time to Maximum Serum Concentration (Cmax) 
Vz 
Apparent Volume of Distribution During Terminal Phase 
 
 


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1. INTRODUCTION  
This pharmacokinetic analysis plan describes the rules and conventions to be used in the presentation 
and analysis of PK data to be presented for Protocol [OBI-888-001]. This document is based on 
protocol, version 4.0, dated 07 Jun 2019.     
This document reiterates key PK elements in the study design of Protocol OBI-888-001and thoroughly 
describes the presentations and summaries of PK data as well as the noncompartmental analysis 
(NCA)  to be included in the PK Report and summarized in the clinical study report (CSR) for this 
protocol. Shells and mockups are given for all PK-related tables, figures, and listings planned for 
inclusion in the CSR and/or PK Report. At minimum, mean PK plots as well as listings and summaries 
of OBI-888 concentrations and PK parameters will be included in the CSR, while all tables, figures, 
and listings described in this document will be included in the PK Report.  
2. CLINICAL STUDY METHODS 
2.1. Analysis Groups 
This is a Phase I, open-label, dose-escalation (Part A) and cohort expansion (Part B) study of 
OBI-888, a humanized mAb targeting Globo H in patients with locally advanced or metastatic solid 
tumors. Part A is designed to establish the MTD and RP2D of OBI-888. Part B is intended to further 
characterize the safety and clinical activity profile of the RP2D dose of OBI-888 administered as 
monotherapy in patients with locally advanced or metastatic solid tumors.  
2.2. Dose Administration 
OBI-888 were administered as a 90-minute intravenous (IV) infusion on Days 1, 8, 15, and 22 of each 
28-day cycle. The infusion duration may be reduced, at the investigator’s discretion, to 30-60 minutes 
starting with Cycle 3 if the infusions in the first two cycles were well tolerated.   
For Part A (Dose Escalation), OBI-888 will be given at the dose levels of 5, 10, and 20 mg/kg until 
MTD is determined.  For Part B (Cohort Expansion), subjects were treated with 20 mg/kg OBI-888 
since no DLTs have been observed at any dose level tested in Part A, and the MTD was not reached.   
2.3. PK Sampling Schedule 
Blood (serum) samples will be collected at the following time points: C1D1 Pre-infusion (within 1 
day prior-to the infusion), post infusion samples at the end of infusion and at 1 (±15 min), 4 (±15 
min), 8 (±15 min), 24 (± 2 h, on Day2), 72 (±2 h, on Day4) and 168 hours (any time prior to C1D2 
infusion) after the end of the infusion.   


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2.4.  Analytical Methods 
The concentration of OBI-888 in the serum samples were determined using a validated ELISA 
method with an assay range of 468.75 to 30000 ng/mL.  
 
 


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3. PHARMACOKINETIC ANALYSIS METHODS 
3.1. Analysis Population and Handling of Missing Time Points 
The PK population will include all enrolled subjects who receive at least 1 dose of study drug 
and have sufficient PK samples (a sample at the end of administration and at least 3 samples 
during the elimination phase) to include in the PK assessments.  Generally, only values above the 
lower limit of quantification (LLOQ) are used for the estimation of PK parameters. Unless otherwise 
specified below, missing sampling or concentration values should not be imputed, but left missing in 
the calculation of derived PK parameters. If the actual sampling time is missing, but a valid 
concentration value has been measured, the scheduled protocol time may be used for the calculation 
of derived PK parameters.  Collection of serum samples outside of the protocol defined time 
window for the time point will not result in exclusion of the sample result from NCA. Values below 
the lower limit of quantification (LLOQ) will be referred to as below the quantification limit (BQL). 
BQL values that precede the first PK concentration above the LLOQ will be imputed as 0 for linear 
plots and for all calculations including NCA and summary statistics. All other BQL values will be 
treated as missing for all analyses.  
3.2. Demographic and Baseline Characteristics 
Sex, race, age, weight, height, and body mass index (BMI) of subjects in the PK analysis population 
will be listed and summarized (PK Table 1, PK Listing 1). 
3.3. Dosing and Pharmacokinetic Sampling Summary 
Subject dose administration times will be presented (PK Listing 2). Cases that potentially affect the 
analysis will be discussed. Protocol deviations related to dosing or PK sampling will be listed (PK 
Listing 3) and summarized in the PK Report text. Deviations to be included in the PK Report include: 
• Blood specimen not collected 
• Plasma specimen result not obtained 
• Specimen temperature excursion 
• Required specimen collected out of window 
• Any other deviation determined by the PK analyst to be potentially affect PK 
Drug plasma concentrations will be listed by subject (PK Listing 4), with nominal and actual time 


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associated with the sample indicated (nominal time is defined as the time in h since the start time of 
the dose). Both laboratory reported concentration values, and modified concentration values used for 
analysis (for instance, imputation of 0 for a BQL value at baseline) will be included, as separate 
columns, in the listing. Plasma drug concentrations will also be summarized (PK Table 2) and 
plotted. PK Figure 1 and PK Figure 2 will plot all individual subject plasma PK profiles, as linear 
and semi-logarithmic plots, respectively. Subject ID for each individual profile in these figures will 
be shown in a legend.  
3.4. Definition and Estimation of Individual NCA PK Parameters 
PK parameters will be estimated through a NCA using version 8.2 or later of Phoenix® 
WinNonlin® (Pharsight Corporation, Cary, NC). Actual post-dose time will be used for the 
estimation of PK parameters instead of nominal time. Individual PK parameter estimates will be 
listed (PK Listing 5). 
Phoenix® WinNonlin® NCA will use the following settings to compute parameters from plasma PK 
data:   
• Linear Up Log Down calculation method 
• Uniform weighting 
• Intravenous dose 
• Plasma Model Type 
• Lambda Z Acceptance Criteria 
• Rsq adjusted ≥ 0.80 
• Span ≥ 2.0 half-lives 
• Includes ≥ 3 timepoints after Tmax 
 
Tmax (hour): Time to reach the maximum concentration 
- 
directly taken from the observed concentration 
Cmax (µg/mL): Maximum concentration 
- 
directly taken from the observed concentration 
Clast (µg/mL): Concentration at last quantifiable time point 


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- 
directly taken from the observed concentration 
λ (1/h): Elimination rate constant associated with the terminal phase 
- 
estimated terminal slope of the linear regression of log-transformed concentration vs 
time 
- 
The regression analysis should contain data from at least 3 different time points in the 
terminal phase and as many data points as possible, always including the last 
quantifiable concentration but excluding the concentration at Tmax.  
- 
The coefficient of determination Adj_RSq2 should be larger than or equal to 0.80. If at 
least one of these three conditions is not fulfilled, the terminal half-life and the 
parameters depending on t½ will be listed but flagged as not reliably calculated. They 
will generally be excluded from descriptive statistics and statistical testing procedures. 
t½ (h): Terminal elimination half-life 
- 
𝑡𝑡1/2 =
𝑙𝑙𝑙𝑙𝑙𝑙𝑒𝑒2
λ  
AUClast (h*µg/mL): Area under the concentration-time curve from time zero to time the last 
quantifiable time, calculated by log-linear trapezoidal rule. 
AUC∞ (h*µg/mL): Area under the concentration-time curve from time zero to infinite time 
- 
The percentage of extrapolated AUC should not exceed 20% of AUC∞ for each 
individual profile. If the percentage of extrapolated AUC is more than 20%, the 
individual AUC∞ result and the parameters depending on AUC∞ will be listed but 
flagged as not reliably calculated. They will generally not be included in descriptive 
statistics and statistical testing procedures. 
AUMClast (h2*µg/mL): Area under the first moment of the concentration time curve from time zero 
to time the last quantifiable time, calculated by log-linear trapezoidal rule. 
AUMC∞ (h2*µg/mL): Area under the first moment of the concentration-time curve from time zero to 
infinite time 
CL (mL/h): Total body clearance following iv administration 
- 
𝐶𝐶𝐶𝐶=
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 𝑖𝑖𝑖𝑖 "µ𝑔𝑔"
𝐴𝐴𝐴𝐴𝐴𝐴∞
 
Vz (mL): Volume of distribution following iv administration 


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- 
𝑉𝑉𝑧𝑧= 𝐶𝐶𝐶𝐶λ
ൗ 
Vss (mL): Volume of distribution at steady-state following iv administration 
- 
𝑉𝑉𝑠𝑠𝑠𝑠=
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 𝑖𝑖𝑖𝑖 "µ𝑔𝑔"×𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴
(𝐴𝐴𝐴𝐴𝐴𝐴∞)2
 
Dose proportionality 
- 
To investigate the dose proportionality of AUC and Cmax, a statistical analysis using 
the power model will be conducted. The power model will have the form: 
- 
Y = a*(dose)b , where Y is the PK parameter, and a and b are the coefficient and 
exponent, respectively, of the power equation. 
- 
By taking the natural logarithm (ln), the power model can be analyzed using linear 
regression and has the form: 
- 
ln(Y) = ln(a)+b*ln(dose) + error =α + β*ln(dose) + error, 
- 
where α is the intercept, and β is the slope, and ln(dose) is based on the dose size for 
each subject. 
- 
Estimates of slope and intercept along with their 90% confidence intervals will be 
reported. A minimum of 3 values per dose must be available for a given parameter to 
estimate dose proportionality using the power model. 
All calculations will use the actual post-dose times recorded on the CRF. All computed PK parameters 
will be listed by subject and summarized by dose group in the Escalation Phase and by disease cohort 
in the Expansion Phase (mean, standard deviation, coefficient of variation, minimum, maximum, 
number of observations). Individual and mean (by time) concentrations versus time will be plotted for 
each dose on both linear and natural logarithm scales.  
3.5. Descriptive Statistics 
Subject-specific PK parameter estimates will be listed (PK Listing 5). PK estimates will be 
summarized in PK Table 3. Summary statistics will include mean, standard deviation (SD), minimum, 
maximum, median, coefficient of variation as a percent (CV%), GM, and geometric standard deviation 
(GSD) 
 
 


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4. LISTING OF PROPOSED TABLES, FIGURES, AND LISTINGS 
 
PK Table 1: Summary of Demographic and Baseline Characteristics of Subjects Included in the PK 
Analysis Population 
Parameter 
PK Analysis Population 
(N=X) 
Sex – N (%) 
 
Male 
 
Female 
 
Age (years) 
 
Mean (SD) 
 
Median 
 
Min, Max 
 
Height (cm) 
 
Mean (SD) 
 
Median 
 
Min, Max 
 
Weight (kg) 
 
Mean (SD) 
 
Median 
 
Min, Max 
 
BMI (kg/m2) 
 
Mean (SD) 
 
Median 
 
Min, Max 
 
Race – N (%) 
 
American Indian or Alaska Native 
 
Asian 
 
Black or African American 
 
Native Hawaiian or other Pacific 
Islander 
 
White 
 
 
 
 


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PK Table 2: Summary Statistics for Concentrations by Nominal Time 
 
Subject ID 
 
OBI-888 Concentration (µg/mL) by Nominal Time1 After Dose 
(h) 
0 
1.5 
2.5 
4.5 
7.5 
25.5 
73.5 
169.5 
UXX-001 
x  
x  
x  
x  
x  
x  
x  
x  
UXX-002 
x  
x  
x  
x  
x  
x  
x  
x  
UXX-003 
x  
x  
x  
x  
x  
x  
x  
x  
…  
x  
x  
x  
x  
x  
x  
x  
x  
Statistics 
 
 
 
 
 
 
 
 
N2  
x  
x  
x  
x  
x  
x  
x  
x  
Mean  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
SD  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
GM  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
x.x  
(Min, Max)  
(x, x)  
(x, 
x)  
(x, 
x)  
(x, 
x)  
(x, 
x)  
(x, 
x)  
(x, 
x)  
(x, x)  
1 Times are relative to time of dosing. 
2 Number of data points used to compute the summary statistics. For calculation of summary statistics, BQL values were imputed as 0 
if they did not come after a PK sample concentration that is above the LLOQ and treated as missing otherwise. 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 45 of 51 
 
PK Table 3: Summary Statistics for PK Parameters 
Statistic 
Tmax 
(h) 
Cmax 
(µg/mL) 
Cmax_D 
(µg/mL/mg) 
AUC(0-last) 
(h×µg/mL) 
AUC(0-last)__D 
(h×µg/mL/mg) 
CL 
(L/h) 
Ke 
(1/h) 
t1/2 
(h) 
Vss 
(L) 
N 
 
 
 
 
 
 
 
 
 
Mean 
 
 
 
 
 
 
 
 
 
SD 
 
 
 
 
 
 
 
 
 
Min 
 
 
 
 
 
 
 
 
 
Median 
 
 
 
 
 
 
 
 
 
Max 
 
 
 
 
 
 
 
 
 
CV % 
 
 
 
 
 
 
 
 
 
GM 
 
 
 
 
 
 
 
 
 
GSD 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 46 of 51 
 
APPENDIX 1. LIST OF PROPOSED PK FIGURES LIST OF PK FIGURES 
PK Figure 1: Concentration Profiles for All Subjects by Time ..................................................15 
PK Figure 2: Semi-log Concentration Profiles for All Subjects by Time...................................16 
PK Figure 3: Mean Concentration by Nominal Time .................................................................17 
PK Figure 4: Mean Concentration by Nominal Time (Semi-Log) .............................................18 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 47 of 51 
 
PK Figure 1: Concentration Profiles for All Subjects by Time 
 
PK Figure 2: Semi-log Concentration Profiles for All Subjects by Time 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 48 of 51 
 
 
 
PK Figure 3: Mean Concentration by Nominal Time 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 49 of 51 
 
 
PK Figure 4: Mean Concentration by Nominal Time (Semi-Log) 
 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 50 of 51 
 
APPENDIX 2. LIST OF PROPOSED PK LISTINGS TABLE OF PK LISTINGS 
PK Listing 1: Subject Level Demographic and Baseline Characteristics ...................................20 
PK Listing 2: OBI-888 Dosing..............................................................................................21 
PK Listing 3: Protocol Deviations Related to Dosing or PK Samples........................................22 
PK Listing 4: Subject Level OBI-888 Concentrations in Plasma..........................................23 
PK Listing 5: Subject-Specific Pharmacokinetic Parameters .....................................................24 
PK Listing 1: Subject Level Demographic and Baseline Characteristics 
Subject ID  
Sex  
Race 
Age 
(years) 
Height 
(cm) 
Weight 
(kg) 
BMI 
(kg/m2) 
UXX-001 
 
 
 
 
 
 
UXX-002 
 
 
 
 
 
 
UXX-003 
 
 
 
 
 
 
….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PK Listing 2: OBI-888 Dosing 
Subject ID  Dose 
(mg)  
Date of 
Infusion  
Start Time  
End Time  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PK Listing 3: Protocol Deviations Related to Dosing or PK Samples 
Subject 
ID 
DV 
Number 
Deviation 
Description 
Study 
Day 
Reason 
for 
Deviation 
Deviation 
Resulted 
in AE? 
Deviation 
Resulted in 
Subject 
Termination? 
Deviation 
Affected 
Product 
Stability? 
Specimen 
Type 
Affected 
Visit 
Number 
Deviation 
Category 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: This listing contains a subset of the protocol deviations in the clinical database relevant to the PK analysis 
 
 


Statistical Analysis Plan: OBI-888-001 
Review Status: Final  
 
Version: 2.0 
 
Version Date: 02JUN2022 
Page 51 of 51 
 
PK Listing 4: Subject Level OBI-888 Concentrations in Plasma 
Subject 
ID 
Nominal 
Time1 
(h) 
Actual 
Time1 
(h) 
Lab Reported 
Drug 
Concentration 
(µg/mL) 
Analysis Drug 
Concentration 
(µg/mL) 
Used in Ke 
Calculations 
Excluded 
from NCA 
Reason 
for 
Exclusion 
from 
NCA 
UXX-001 
0  
0  
BQL  
0  
No  
No 
 
UXX-002 
0.5  
0.5  
50.1  
50.1  
No  
No 
 
UXX-003 
1.5 
1.52  
BQL  
missing  
No  
No 
 
… 
 
 
 
 
 
 
 
1Times are relative to time of dose. For Actual Times, out-of-window times are indicated by an asterisk 
 
 
PK Listing 5: Subject-Specific Pharmacokinetic Parameters 
Subject 
ID 
Tmax 
(h) 
Cmax 
(µg/mL) 
Cmax_D 
(µg/mL/mg) 
AUC(0-last) 
(h×µg/mL) 
AUC(0-last)__D 
(h×µg/mL/mg) 
CL 
(L/h) 
Ke 
(1/h) 
t1/2 
(h) 
Vss 
(L) 
UXX-001 
 
 
 
 
 
 
 
 
 
UXX-002 
 
 
 
 
 
 
 
 
 
UXX-003 
 
 
 
 
 
 
 
 
 
…