Actively Recruiting
A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
Led by Outpace Bio, Inc. · Updated on 2025-12-18
30
Participants Needed
4
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older at the time of consent
- Histologically confirmed high-grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
- Recurrent platinum-resistant disease with recurrence within 6 months of last platinum-based therapy
- Received at least two prior lines of systemic chemotherapy including platinum-based chemotherapy
- Received prior PARP inhibitor therapy if BRCA1/2 mutation is known
- Measurable disease present
- Consent to provide archived tumor tissue sample
- ECOG performance status of 0 or 1
- Adequate organ function
- Alkaline phosphatase less than or equal to 2.5 times upper limit of normal
- Dyspnea grade 1 or less and oxygen saturation above 92% on room air
- Left ventricular ejection fraction 50% or higher
- Life expectancy of at least 3 months
- Adequate venous access
- Negative screen for infectious disease markers
- Negative serum pregnancy test
- Agreement to abstain from heterosexual activity or use two forms of effective contraception
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Uncontrolled bacterial, fungal, or viral infections
- Active infection requiring systemic therapy
- Bleeding or clotting disorders or high risk of severe bleeding
- Any primary immunodeficiency condition
- History of allogenic tissue or solid organ transplant
- Active autoimmune disease
- Concurrent treatment with systemic high-dose corticosteroids
- Unresolved acute effects from prior therapy
- Active invasive cancer other than the study cancer
- Significant lung disease
- Clinically significant pericardial effusion
- Prior radiotherapy within 2 weeks before study intervention
- Major surgery within 28 days before enrollment
- Received investigational agents or tumor vaccines recently
- Chemotherapy within the last 3 weeks
- History of severe ascites (grade 3 or higher)
- Active involvement of the central nervous system
- Received a live vaccine within 30 days before study treatment
- Prior CAR T cell therapy
- Prior mesothelin-targeted therapy
- Dependent on intravenous hydration or total parenteral nutrition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
3
Roswell Park
Buffalo, New York, United States, 14203
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
John Ferraro, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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