A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.

A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.

Inclusion criteria

• Age ≥ 18 years of age at the time of signing the informed consent form.
• Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
• Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.
• Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
• Measurable disease.
• Consent to provide archived tumor tissue sample.
• ECOG performance status of 0 or 1.
• Adequate organ function.
• HLA-A *02:01 or HLA-A *02:02
• PRAME positive tumor

Exclusion criteria

• Women of child-bearing potential who are pregnant or breastfeeding.
• Uncontrolled bacterial, fungal, or viral infections.
• Active infection requiring systemic therapy.
• Bleeding or thrombotic disorders or at risk for severe hemorrhage.
• Any form of primary immunodeficiency.
• Had an allogenic tissue/solid organ transplant.
• Active autoimmune disease.
• Concurrent treatment with systemic high dose corticosteroids.
• Unresolved acute effects of any prior therapy.
• Other exclusions as stated in the protocol.