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

Sponsor
Outpace Bio, Inc.
Study ID
NCT07664735
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OPB-201 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OPB-201 Treatment Arm
    OPB-201 Treatment Arm

Primary Outcome Measure

Safety [ Time Frame: 2 years ]

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