NCT07664735RecruitingPhase 1
A Phase 1 Study to Evaluate 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.
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- 30 Jun 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- Outpace Bio, Inc.
- Diseases
- Melanoma, Endometrial cancer, Ovarian cancer
- NCT number
- NCT07664735
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 30 Jun 2026 to the primary completion date, Jun 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had an allogenic tissue/solid organ transplant.
- Concurrent treatment with systemic high dose corticosteroids.
- Unresolved acute effects of any prior therapy.
Other illness
- Uncontrolled bacterial, fungal, or viral infections.
- Active infection requiring systemic therapy.
- Bleeding or thrombotic disorders or at risk for severe hemorrhage.
- Active autoimmune disease.
Other
- Women of child-bearing potential who are pregnant or breastfeeding.
- Any form of primary immunodeficiency.
- Other exclusions as stated in the protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.