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Clinical Trials in the USA / NCT07106762
Recruiting Phase 2/3

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

NCT07106762 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/3
Started
2025-09-30
Last updated
2026-07-29

Condition(s) studied

Urothelial Cancer

Investigational drug(s) / intervention(s)

Iza-brenCisplatinGemcitabineCarboplatin

Iza-bren: Specified dose on specified days

Cisplatin: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Carboplatin: Specified dose on specified days

Study summary

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants must have histologically confirmed advanced urothelial carcinoma. * Participants must be eligible to receive platinum-based chemotherapy. * Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy. * Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment. * Participants must have ≥ 1 measurable lesion per RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria: * Participants must not have platinum-based chemotherapy exposure within 12 months. * Participants must not have received \>2 prior regimens irrespective of the setting. * Participants must not have prior ADC therapy targeting EGFR or HER3. * Participants must not have prior therapy with topoisomerase 1 inhibitor. * Participants must not have active, untreated brain metastases. * Other protocol-defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

Trial sites (163)

FacilityCityRegionStatus
Local Institution - 0167 Gilbert Arizona Not Yet Recruiting
Local Institution - 0162 Fullerton California Not Yet Recruiting
Palo Alto Center-Palo Alto Medical Foundation Research Institute Palo Alto California Recruiting
Sutter Health - Sutter Institute for Medical Research Sacramento California Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California Recruiting
Pacific Hematology Oncology Associates San Francisco California Recruiting
Sutter Santa Rosa Santa Rosa California Recruiting
Rocky Mountain Cancer Centers, LLP Denver Colorado Recruiting
Local Institution - 0245 Dillon Colorado Withdrawn
Shaw Cancer Center Edwards Colorado Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Miami Cancer Institute at Baptist Health, Inc. Miami Florida Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Local Institution - 0195 Boston Massachusetts Not Yet Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Local Institution - 0248 Buffalo New York Withdrawn
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Fairview Hospital Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
The James Outpatient Care West Campus Columbus Ohio Recruiting
Cleveland Clinic - Hillcrest Hospital Mayfield Heights Ohio Recruiting
Local Institution - 0141 Portland Oregon Not Yet Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Local Institution - 0084 Nashville Tennessee Not Yet Recruiting
Texas Oncology - West Texas Abilene Texas Recruiting
Local Institution - 0187 Austin Texas Not Yet Recruiting
Intermountain Medical Center Murray Utah Recruiting
St George Regional Hospital Cancer Center St. George Utah Recruiting
University of Virginia Health System Charlottesville Virginia Recruiting
Local Institution - 0188 Norfolk Virginia Not Yet Recruiting
Local Institution - 0200 Seattle Washington Not Yet Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
University of Washington Medical Center - Montlake Seattle Washington Recruiting
Instituto Alexander Fleming Caba Buenos Aires Recruiting
Hospital Británico de Buenos Aires CABA Buenos Aires Recruiting
Asociación de Beneficencia Hospital Sirio Libanés Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Hospital Italiano de Buenos Aires ABB Buenos Aires F.D. Recruiting
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo Córdoba Argentina Recruiting

+ 123 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106762 on ClinicalTrials.gov ↗ ← All trials in the USA