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

Launched by BRISTOL-MYERS SQUIBB · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Izalontamab Brengitecan for people with advanced urothelial cancer, a type of bladder cancer that has spread to other parts of the body. The trial will compare this new treatment to the standard platinum-based chemotherapy, which is often used when the cancer continues to grow after immunotherapy (a type of treatment that helps the immune system fight cancer).

People who might be able to join this study are those with confirmed advanced urothelial cancer who have already tried immunotherapy and whose cancer has progressed. Participants need to be well enough to receive chemotherapy and have at least one tumor that can be measured. The trial is for adults of any gender, and participants should not have had platinum chemotherapy recently, more than two prior treatment plans, or certain other cancer treatments. If you join, you will receive either the new drug or standard chemotherapy, and your health and response to treatment will be carefully monitored. This trial is not yet open for enrollment but aims to find better treatment options for patients whose cancer has not responded to previous therapies.

Gender

ALL

Eligibility 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.