RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Generate Biomedicines • ClinicalTrials.gov ID: NCT07484022

Registry updated: 2026-10-13

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Description

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.

Interventions

GB-4362 (Drug)
GB-4362 is an investigational monoclonal antibody
enfortumab vedotin (EV) (Drug)
Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).
Pembrolizumab (Drug)
Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.

Eligibility criteria

Inclusion Criteria * Planned to initiate, or (for dose escalation only) already receiving, standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer. * Age ≥18 years. * ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion). * Life expectancy ≥3 months, as determined by the investigator. * Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects. * Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. Exclusion Criteria * Uncontrolled diabetes. * Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met: * CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis. * The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment). * The participant does not have leptomeningeal disease. * No Grade \> 1 sensory or motor peripheral neuropathy. * History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody. * Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up. * Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements

Conditions

Advanced Urothelial Cancer Metastatic Urothelial Carcinoma

Locations

City of Hope — Duarte, California, United States
COH Lennar — Irvine, California, United States
Orlando Health — Orlando, Florida, United States
COH Atlanta — Tucker, Georgia, United States
COH Chicago — Zion, Illinois, United States
Rutgers — New Brunswick, New Jersey, United States
Start New York, LLC — Lake Success, New York, United States
MSK — New York, New York, United States
MDACC — Houston, Texas, United States
The University of Virgina — Charlottesville, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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