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

Starting soon · Phase 1

Conditions studied: Endometrial Cancer Recurrent, Endometrial Cancer, Advanced Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Recurrent, Platinum Resistant Ovarian Cancer, Endometrial Cancers

In brief

The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.

Key facts

Study ID

NCT07664735

Run by

Outpace Bio, Inc.

People needed

30

Starts

2026-06-30

Expected to finish

2030-09-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.