Study on OBI-902 for Adults with Advanced Solid Tumors

Inclusion Criteria

• Adults aged 18 or older.
• Must agree to participate and sign a consent form.
• Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be cured with local treatments.
• Have tried standard treatments, or such treatments are not effective or have been declined.
• Have at least one tumor that can be measured.
• Be in good general health with a performance status of 0 or 1.
• Have good liver, kidney, and blood function based on specific tests.
• Be willing to undergo necessary tests and procedures, including a tumor biopsy.
• Women of childbearing age must test negative for pregnancy and use reliable birth control during and after the study.
• Men must agree to use birth control during and after the study.
• Not be breastfeeding.
• HIV-positive participants are eligible if their condition is stable and controlled.
• Participants with controlled hepatitis B or C are eligible.
• For Part B, participants must have specific types of tumors: HER2-negative breast cancer, endometrial cancer, or cholangiocarcinoma.

Exclusion Criteria

• Recent chemotherapy or radiation therapy within the last 3 weeks.
• Recent major surgery or significant injury within the last 28 days.
• Severe nerve damage.
• History of organ transplant, except for corneal transplant without ongoing treatment.
• Unresolved side effects from previous cancer treatments, except for hair loss.
• Previous treatment targeting TROP2 (for Phase 2 only).
• Heart rhythm issues as shown on an ECG.
• Allergy to OBI-902 or its ingredients.
• Untreated brain metastases, unless treated and stable for at least 4 weeks.
• Serious heart problems or other life-threatening conditions.
• Taking medications that are not allowed in the study.