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Recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT07484022

Public ClinicalTrials.gov record NCT07484022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07484022
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Generate Biomedicines
Industry
Enrollment
37 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2027
Last update posted
Jun 17, 2026

2026 – 2027

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
City of Hope Duarte California 91010 Recruiting
COH Lennar Irvine California 92618 Recruiting
Orlando Health Orlando Florida 32806 Recruiting
COH Atlanta Tucker Georgia 30084 Recruiting
COH Chicago Zion Illinois 60099 Recruiting
Rutgers New Brunswick New Jersey 22908 Recruiting
Start New York, LLC Lake Success New York 11042 Recruiting
MSK New York New York 10065 Recruiting
MDACC Houston Texas 77030 Recruiting
The University of Virgina Charlottesville Virginia 22908 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07484022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07484022 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →