A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of GB-5267, an IL-18 Armored CAR T Cell Product Targeting MUC16, in Patients With Platinum-Resistant Ovarian Cancer
Roswell Park Cancer Institute
Summary
This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.
Description
PRIMARY OBJECTIVE: * To evaluate the safety and tolerability of GB-5267 in patient with platinum resistant ovarian cancer * To determine the maximum tolerated dose (MTD). SECONDARY OBJECTIVE: \- To assess the anti-tumor activity of GB-5267 This is a dose escalation study of GB-5267 In Cohort 1 Patients receive IV only infusion. Dose escalation continues until Maximum tolerated dose (MTD) is established. Once the MTD has been established Cohort B (Dose expansion with Combined IV and IP Infusion) is intended to assess whether this approach enhances local antitumor effects in the peritoneal c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age * Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma. * Must have platinum-resistant disease, defined as: 1. Progression of disease within 6 months of last platinum-based chemotherapy, OR 2. Patients who have an intolerance for further platinum-based therapy. * CA125 \> 2 x ULN as assessed at the local lab by a 501(k) cleared test at Screening. * Eastern Cooperative…
Interventions
- BiologicalGB-5267 - IV only
IV infusion
- BiologicalGB-5267 -Combined IV and IP Infusion
IV and IP Infusion
Location
- Roswell Park Comprehensive Cancer CenterBuffalo, New York