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

This study is testing a new drug called GB-4362 in combination with standard treatments, enfortumab vedotin (EV) and pembrolizumab, for people with advanced or metastatic urothelial cancer (a type of bladder cancer). GB-4362 is designed to reduce side effects like nerve damage (peripheral neuropathy) that can be caused by enfortumab vedotin. Researchers want to see how safe this combination is and how well people tolerate it. You might be able to join if you are an adult with advanced urothelial cancer and are planning to receive EV and pembrolizumab. The study aims to find the best dose of GB-4362. The current status of this study is unclear.

Study design: This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It plans to enroll 37 participants to evaluate different dose levels of GB-4362.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your safety will be monitored from the first dose of GB-4362 through 18 weeks after your last dose, or until you start other cancer treatments.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 18+InterventionalTreatment

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~37 participants

Updated 2026-06-18 on ClinicalTrials.gov

What's tested:GB-4362enfortumab vedotin (EV)Pembrolizumab

At a glance

Recruiting sites

10 of 10 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of AEs and SAEs

Measured over 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).

Conditions

Advanced Urothelial Cancer

Metastatic Urothelial Carcinoma

Where it's being run

10 sites across 8 states

California2

New York2

Florida1

Georgia1

Illinois1

New Jersey1

Texas1

Virginia1

Who to contact

Study Contact

[email protected]

(888) 5471235

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

Incidence of AEs and SAEsFrom 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).

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