Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

Inclusion Criteria

• •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 solid tumors.
• •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. In the latter case, the informed consent must state the effective therapies the patient is declining.
• •5. Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •7. Adequate organ function defined as:
• •a. Hepatic:
• •i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
• •ii. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
• •iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
• •b. Renal:
• •i. Creatinine clearance \>50 mL/minute using Cockcroft Gault equation
• •c. Hematologic:
• •i. Absolute neutrophil count ≥1,500/µL
• •ii. Platelets ≥100,000/µL
• •iii. 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 are acceptable at baseline.
• •9. Females of childbearing potential must have negative 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.
• •Patient 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.
• •13. Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
• •14. Patients in Part B (Cohort-Expansion) must have documented Globo H H score of at least 100 from a qualified laboratory IHC assay in one of the 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).
• •6. Receipt of any prior therapy targeting Globo H.
• •7. Known hypersensitivity to OBI 999 or its excipients.
• •9. Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
• •10. Any medical co morbidity 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.
• •11. Is receiving any concurrent prohibited medication