Clinical Trial

Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

Recruiting Phase 1
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Summary
The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.
Protocol Amendment History 3 changes
notable Trial sites expanded: 7 -> 10 locations 2026-06-19
notable Trial sites expanded: 2 -> 6 locations 2026-05-16
critical Recruitment opened 2026-04-08
Trial Details
NCT Number NCT07484022
Lead Sponsor Generate Biomedicines
Conditions Advanced Urothelial Cancer, Metastatic Urothelial Carcinoma
Enrollment 37 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-18