A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
NCT ID: NCT07030907
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-06-16
2030-05-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OPB-101 Treatment Arm
OPB-101
An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine
Interventions
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OPB-101
An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
3. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
4. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
5. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
6. Measurable disease.
7. Consent to provide archived tumor tissue sample.
8. ECOG performance status of 0 or 1.
9. Adequate organ function.
10. Alkaline phosphatase ≤ 2.5 x ULN
11. ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air.
12. LVEF ≥ 50%
13. Life expectancy of ≥ 3 months
14. Adequate venous access.
15. Negative screen for infectious disease markers.
16. Negative serum pregnancy test.
17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
Exclusion Criteria
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. Active invasive cancer other than the cancer under study.
11. Significant lung disease.
12. Clinically significant pericardial effusion.
13. Prior radiotherapy within 2 weeks of start of study intervention.
14. No major surgery within 28 days prior to enrollment.
15. Received investigational agents or tumor vaccines.
16. Received chemotherapy within the previous 3 weeks.
17. History of grade ≥ 3 ascites.
18. Active CNS involvement.
19. Received a live vaccine within 30 days prior to study treatment.
20. Received prior CAR T cell therapy.
21. Received prior mesothelin targeted therapy.
18 Years
FEMALE
No
Sponsors
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Outpace Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Roswell Park
Buffalo, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ira Winer, M.D.
Role: primary
Melissa Geller
Role: primary
Other Identifiers
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OPB-101-OV-101A
Identifier Type: -
Identifier Source: org_study_id