A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Outpace Bio, Inc.
Study ID
NCT07030907
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Ovarian Cancer
  • Ovarian Cancer Recurrent
  • Platinum Resistant Ovarian Cancer

Eligibility Criteria

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

Interventions

  • OPB-101 — BIOLOGICAL
    An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine

Study Details

The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.

Key Dates

Start date
Jun 16, 2025
Status verified
Dec 2025
Primary completion
May 15, 2028
Completion
May 15, 2030

Study Design

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

Arms

  • Experimental: OPB-101 Treatment Arm

Primary Outcome Measure

Safety [ Time Frame: 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Ira Winer, M.D.
[email protected]
313-576-9435
University of MinnesotaMinneapolisMinnesota55455
Melissa Geller
[email protected]
612-624-2620
Melissa Geller, MD (PRINCIPAL_INVESTIGATOR)
Roswell ParkBuffaloNew York14203
Emese Zsiros, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Amir Jazaeri, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Karmanos Cancer Institute· Detroit, MIUniversity of Minnesota· Minneapolis, MNRoswell Park· Buffalo, NYMD Anderson Cancer Center· Houston, TX

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