Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
GB-4362: GB-4362 is an investigational monoclonal antibody
enfortumab vedotin (EV): Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).
Pembrolizumab: Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of AEs and SAEs — From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first).
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| COH Lennar | Irvine | California | Recruiting |
| Orlando Health | Orlando | Florida | Recruiting |
| COH Atlanta | Tucker | Georgia | Recruiting |
| COH Chicago | Zion | Illinois | Recruiting |
| Rutgers | New Brunswick | New Jersey | Recruiting |
| Start New York, LLC | Lake Success | New York | Recruiting |
| MSK | New York | New York | Recruiting |
| MDACC | Houston | Texas | Recruiting |
| The University of Virgina | Charlottesville | Virginia | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07484022 on ClinicalTrials.gov ↗ ← All trials in the USA