Recruiting
Phase 1

OPB-201

Sponsor:

Outpace Bio, Inc.

Code:

NCT07664735

Conditions

Endometrial Cancer Recurrent

Endometrial Cancer

Advanced Endometrial Cancer

Ovarian Cancer

Ovarian Cancer Recurrent

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OPB-201

Study Details

Brief summary:

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

Endometrial Cancer Recurrent

Endometrial Cancer

Advanced Endometrial Cancer

Ovarian Cancer

Ovarian Cancer Recurrent

Study ID

NCT07664735

Start date

Jun 30, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OPB-201 Treatment Arm

OPB-201 Treatment Arm

Interventions

OPB-201

A multi-transgene autologous TCR T cell therapy with optimized alpha and beta chains of a TCR specific for a peptide derived from PRAME and a designed protein which enhances TCR T cell potency.

Primary outcome measure

  • Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths. [ Time Frame: 2 years ]
  • Incidence of dose-limiting-toxicities (DLTs) [ Time Frame: 28 days ]
  • To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

UCSF - Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

David Oh, MD

Emory - Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Jennifer Scalici, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Radhika Gogoi, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Melissa Geller, M.D.

612-624-2620ccinfo@umn.edu

Principal Investigator:

Melissa Geller, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Amir Jazaeri, MD

More Information

Sponsor

Outpace Bio, Inc.

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Outpace
  • Ovarian cancer
  • Endometrial cancer
  • advanced ovarian cancer
  • advanced endometrial cancer
  • cell therapy
  • TCR-T
  • TCR
  • PRAME directed TCR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Outpace Bio, Inc. on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.