OPB-201 therapy for recurrent endometrial and platinum-resistant ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study tests OPB-201, a personalized T cell therapy that uses a patient’s own T cells engineered to recognize PRAME, in recurrent endometrial cancer and platinum-resistant ovarian cancer. The trial evaluates safety and identifies an optimal dose across two dose-escalation cohorts (Phase 1a/1b). Participants receive the engineered cells as a one-time infusion in the hospital with close monitoring in the initial months. Eligible patients have measurable disease, prior platinum therapy, and a PRAME-positive tumor, among other criteria. The study is conducted at three U.S. cancer centers and is sponsored by Outpace Bio, Inc.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• UCSF - Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• Emory - Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: John Ferraro
• Email: jferraro@outpacebio.vom
• Phone: 3039290208

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.