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

RecruitingPhase 1Ages 18 Years - anyFemaleOutpace Bio, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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: 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.
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What it tests

  • OPB-201
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Where

5 sites
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
Emory - Winship Cancer Institute
Atlanta, United States
Karmanos Cancer Institute
Detroit, United States
University of Minnesota
Minneapolis, United States
MD Anderson Cancer Center
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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