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Not yet recruitingNCT07664735Updated Jun 24, 2026

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

A Phase 1 interventional study of OPB-201 in Endometrial Cancer Recurrent, Endometrial Cancer and Advanced Endometrial Cancer, sponsored by Outpace Bio, Inc.. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Outpace Bio, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Endometrial Cancer Recurrent
  • Endometrial Cancer
  • Advanced Endometrial Cancer
  • Ovarian Cancer
  • Ovarian Cancer Recurrent
  • Platinum Resistant Ovarian Cancer
  • Endometrial Cancers

Keywords

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

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Outpace Bio, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    OPB-201 Treatment Arm

    OPB-201 Treatment Arm

    Biological: OPB-201

Interventions

  • BiologicalOPB-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. Safety

    Incidence of dose-limiting-toxicities (DLTs)

    Time frame: 28 days

  3. Safety

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

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07664735
Lead sponsor
Outpace Bio, Inc.
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jun 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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