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Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Trial Status: active
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for
Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07106762.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
Kentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium