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

Recruiting now · Phase 1

Conditions studied: Advanced Urothelial Cancer, Metastatic Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07484022

Run by

Generate Biomedicines

People needed

37

Starts

2026-06-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned to receive 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).
• Weight ≥50 kg at screening.
• 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.

You may not qualify if…

• Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).
• Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.
• 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.
• Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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