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.
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 cohort.
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.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function defined as:
- 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
- Serum bilirubin ≤1.5 × ULN
- Creatinine clearance >30 mL/minute using Cockcroft Gault equation
- 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 are
acceptable at baseline.
9. Females of childbearing potential must have 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
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 qualifying, documented Globo H
H-score in sponsor-selected tumor types to be enrolled in the respective cohort:
- 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
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
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.
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 and/or leptomeningeal
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