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Izalontamab Brengitecan versus Platinum Chemotherapy for Advanced Urothelial Cancer

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07106762

This trial tests whether izalontamab brengitecan works better than standard platinum-based chemotherapy for people with metastatic urothelial (bladder) cancer that progressed after prior immunotherapy.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment470 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionschemotherapy, Izalontamab, Immunotherapy
Locations162 sites (Gilbert, Arizona and 161 other locations)
Trial IDNCT07106762 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 study compares izalontamab brengitecan with investigator-choice platinum-based chemotherapy (cisplatin or carboplatin with gemcitabine) in patients with advanced or metastatic urothelial carcinoma who have progressed on prior anti–PD-(L)1 therapy. Eligible participants must have histologic confirmation, at least one measurable lesion per RECIST v1.1, and ECOG performance status 0–1, with limited prior lines of therapy and no recent platinum exposure within 12 months. Participants will be assigned to one of the treatment arms and followed for tumor response, progression-free survival, and safety outcomes. The trial is sponsored by Bristol-Myers Squibb and is open at selected U.S. clinical sites in Arizona and California.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced or metastatic urothelial carcinoma who progressed on prior anti–PD-(L)1 therapy, have ECOG 0–1, at least one measurable lesion, are eligible for platinum chemotherapy, have had no platinum exposure within the past 12 months, and have received no more than two prior regimens.

Not a fit: Patients unlikely to benefit include those with recent platinum exposure within 12 months, more than two prior systemic regimens, prior ADCs targeting EGFR or HER3, prior topoisomerase I inhibitor therapy, or poor performance status beyond ECOG 1.

Why it matters

Potential benefit: If successful, the drug could offer a more effective treatment option than standard platinum chemotherapy for patients whose cancer progressed after immunotherapy.

How similar studies have performed: Other antibody–drug conjugates (for example enfortumab vedotin and sacituzumab govitecan) have shown clinical benefit in post–immunotherapy urothelial carcinoma, but izalontamab brengitecan is a newer agent with limited prior phase data in this disease.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 161 other locations

+112 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urothelial CancerBladder cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.