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RecruitingLast updated: 19 February 2026

IZABRIGHT-Bladder01: Evaluating an antibody-drug conjugate called Izalontamab brengitecan compared to chemotherapy in people with metastatic urothelial cancer who have progressed on prior treatmentA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

IZABRIGHT-Bladder01

Clinical summary

Summary

You may be eligible for this study if you have confirmed advanced or metastatic urothelial carcinoma and have progressed on or after treatment with immunotherapy.

Eligible participants will be randomly allocated (by chance) to receive either Izalontamab Brengitecan or platinum-based chemotherapy (cisplatin, gemcitabine, carboplatin).

Conditions

This trial is treating people with advanced or metastatic urothelial cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07106762 *
  • 2025-522400-24 *
  • CA244-0012; U1111-1322-9071

Trial sponsor

Bristol-Myers Squibb

Scientific Title

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

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