Overview

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

Eligibility

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.