Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Outpace Bio, Inc.
A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 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
You may not be if
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.
