A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors

Inclusion Criteria

• •1. At least 18 years of age
• •2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
• •3. Recovered from toxicities of prior therapy to Grade 0 or 1
• •4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •6. Acceptable liver function:
• •1. Bilirubin ≤1.5 × institutional ULN
• •2. AST and ALT ≤3.0 × ULN, or ≤5.0 × ULN for subjects with liver involvement
• •7. Acceptable renal function:
• •a. Creatinine clearance \>30 mL/min according to the Cockcroft-Gault formula
• •8. Acceptable hematologic status (without hematologic support, other than red blood cell transfusion):
• •1. ANC ≥1500 cells/μL
• •2. Platelet count ≥100,000/μL
• •3. Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed).
• •9. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation.
• •10. Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
• •11. Tumor progression after most recent therapy
• •12. Available tumor tissue, either archival or fresh (fresh preferred).
• •13. For treatment, an AKR1C3 IHC H-score of ≥ 100 using a validated IHC assay in one of the following tumor types to be enrolled in the respective cohort:
• •1. Cohort A: Pancreatic Adenocarcinoma
• •2. Cohort B: Basket (any solid tumor type other than pancreatic adenocarcinoma)