Recruiting
Phase 1

GB-4362, Enfortumab & Pembrolizumab

Sponsor:

Generate Biomedicines

Code:

NCT07484022

Conditions

Advanced Urothelial Cancer

Metastatic Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GB-4362

enfortumab vedotin (EV)

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Advanced Urothelial Cancer

Metastatic Urothelial Carcinoma

Study ID

NCT07484022

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GB-4362 in Combination With Enfortumab Vedotin and Pembrolizumab

Interventions

GB-4362

GB-4362 is an investigational monoclonal antibody

enfortumab vedotin (EV)

Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).

Pembrolizumab

Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.

Primary outcome measure

  • Incidence of AEs and SAEs [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Study Contact

(888) 5471235clinicaltrials@generatebiomedicines.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Susan Hmwe Manager Clinical Research

626-218-4081shmwe@coh.org

COH Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Susan Hmwe Manager Clinical Research

626-218-4081shmwe@coh.org

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Janice Porter M Clinical Research Screening & Eligibility Manager

321-841-7246janice.porter@orlandohealth.com

COH Atlanta

Recruiting

Tucker, Georgia, United States, 30084

Contacts

Susan Hmwe Manager Clinical Research

626-218-4081shmwe@coh.org

COH Chicago

Recruiting

Zion, Illinois, United States, 60099

Contacts

Susan Hmwe Manager Clinical Research

626-218-4081shmwe@coh.org

Rutgers

Recruiting

New Brunswick, New Jersey, United States, 22908

Contacts

Kassie DiOrio Manager

732-454-9795kassie.diorio@rutgers.edu

Start New York, LLC

Recruiting

Lake Success, New York, United States, 11042

Contacts

Camilita Goberdhan

347-476-1959camilita.goberdhan@startresearch.com

MSK

Recruiting

New York, New York, United States, 10065

Contacts

Sam Funt PI

646-888-4770funts@mskcc.org

MDACC

Recruiting

Houston, Texas, United States, 77030

Contacts

Cindy Jiang PI

713-876-4652CYJiang@mdanderson.org

The University of Virgina

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Clinical Trials Navigator

434-982-0539uvacancertrials@uva.com

More Information

Sponsor

Generate Biomedicines

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • GB-4362
  • Enfortumab Vedotin
  • Pembrolizumab
  • Peripheral Neuropathy
  • Antibody-Drug Conjugate
  • MMAE
  • Phase 1 Oncology
  • Dose Escalation
  • Dose Expansion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Generate Biomedicines on 2026-06-18.