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Phase 2/3 Trial of Izalontamab Brengitecan for Metastatic Urothelial Cancer

This study is testing a new drug, Izalontamab Brengitecan (Iza-bren), against standard platinum-based chemotherapy (Cisplatin, Gemcitabine, or Carboplatin) for people with metastatic urothelial cancer. This is for individuals whose cancer has progressed after receiving immunotherapy. The study aims to see how well Iza-bren works compared to chemotherapy in slowing down cancer growth and helping people live longer. You might be able to join if you have advanced urothelial cancer, are eligible for platinum-based chemotherapy, and have already received anti-PD-(L)1 immunotherapy. The study is looking for about 470 participants.

Study design
This is a Phase 2/3 interventional study comparing a new drug to standard chemotherapy. It plans to enroll approximately 470 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to assess how long they live and how long their cancer is controlled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07106762

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~470 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Iza-brenCisplatinGemcitabineCarboplatin

At a glance

Recruiting sites
122 of 163 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Measured over Approximately 3 months
+2 more outcomes measured

Conditions

Urothelial Cancer

Explore related trials

Urothelial Carcinoma

Where it's being run

163 sites across 104 states
California6
Germany6
Spain6
Ohio4
Italy4
Colorado3
New York3
Washington3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

  • Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507Approximately 3 months
  • Phase 3: Progression-Free Survival (PFS)Up to 5 years

    Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

  • Phase 3: Overall Survival (OS)Up to 5 years