This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

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 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:
• •* 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
• •* Renal:
• •* Creatinine clearance \>30 mL/minute using Cockcroft Gault equation
• •* 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 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 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 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 through 4)
• •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 metastases.
• •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