RecruitingPhase 2Phase 3NCT07106762
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
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
Sponsor
Bristol-Myers Squibb
Enrollment
470 participants
Start Date
Sep 30, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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.
Interventions
DRUGIza-bren
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGGemcitabine
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
Locations(157)
View Full Details on ClinicalTrials.gov
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NCT07106762
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