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New combo aims to tame Chemo's nerve damage in bladder cancer

NCT ID NCT07484022

Symptom relief Sponsor: Generate Biomedicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an investigational drug called GB-4362 given alongside standard treatments (enfortumab vedotin and pembrolizumab) for adults with advanced or metastatic urothelial cancer. The goal is to see if GB-4362 can safely neutralize a chemotherapy byproduct that often causes nerve damage. About 37 participants will be enrolled to check safety and how the drug moves through the body.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 Criteria * 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

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Conditions

The condition(s) this trial relates to.

peripheral nervous system disorder transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced urothelial cancer Metastatic urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • COH Atlanta

    RECRUITING

    Tucker, Georgia, 30084, United States

  • COH Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • COH Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • MDACC

    RECRUITING

    Houston, Texas, 77030, United States

  • MSK

    RECRUITING

    New York, New York, 10065, United States

  • Orlando Health

    RECRUITING

    Orlando, Florida, 32806, United States

  • Rutgers

    RECRUITING

    New Brunswick, New Jersey, 22908, United States

  • Start New York, LLC

    RECRUITING

    Lake Success, New York, 11042, United States

  • The University of Virgina

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.