Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer Recurrent | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer Recurrent | — | UNRESOLVED | — |
| Platinum Resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-201 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPB-201 Treatment Arm
- description
- OPB-201 Treatment Arm
- interventionNames
- Biological: OPB-201
Primary outcomes (3)
- measure
- Safety
- timeFrame
- 2 years
- description
- Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths.
- measure
- Safety
- timeFrame
- 28 days
- description
- Incidence of dose-limiting-toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available