drugset / Trial / NCT07484022

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

NCT07484022

Phase 1 Recruiting 37 enrolled Generate Biomedicines
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2026-06
Primary completion
2027-06
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GB-4362 Monoclonal antibody
Background Enfortumab Vedotin Other / unclassified
Background Pembrolizumab Monoclonal antibody

Indications