NCT07489287

GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.

Detailed 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 cavity.

Conditions

• Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GB-5267 - IV only	IV infusion
BIOLOGICAL	GB-5267 -Combined IV and IP Infusion	IV and IP Infusion

Timeline

• Start date: 2026-06-15
• Primary completion: 2028-01-15
• Completion: 2030-01-15
• First posted: 2026-03-24
• Last updated: 2026-03-27

Regulatory

• FDA-regulated drug study