NCT07664735

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
50mo left

Started Jun 2026

Longer than P75 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Sep 2030

First Submitted

Initial submission to the registry

June 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

3.9 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Endometrial Cancer RecurrentEndometrial CancerAdvanced Endometrial CancerOvarian CancerPlatinum Resistant Ovarian CancerEndometrial CancersOvarian Cancer Recurrent

Keywords

OutpaceOvarian cancerEndometrial canceradvanced ovarian canceradvanced endometrial cancercell therapyTCR-TTCRPRAME directed TCR

Outcome Measures

Primary Outcomes (3)

  • Safety

    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

    Incidence of dose-limiting-toxicities (DLTs)

    28 days

  • Safety

    To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s)

    2 years

Study Arms (1)

OPB-201 Treatment Arm

EXPERIMENTAL

OPB-201 Treatment Arm

Biological: OPB-201

Interventions

OPB-201BIOLOGICAL

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.

OPB-201 Treatment Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women of child-bearing potential who are pregnant or breastfeeding.
  • Uncontrolled bacterial, fungal, or viral infections.
  • Active infection requiring systemic therapy.
  • Bleeding or thrombotic disorders or at risk for severe hemorrhage.
  • Any form of primary immunodeficiency.
  • Had an allogenic tissue/solid organ transplant.
  • Active autoimmune disease.
  • Concurrent treatment with systemic high dose corticosteroids.
  • Unresolved acute effects of any prior therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 24, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share