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

June 17, 2026 updated by: Outpace Bio, Inc.

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPB-201 Treatment Arm
Biological: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outpace Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPB-201-BSKT-101A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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