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  • NCT07106762

Not Yet Recruiting

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy - CA244-0012

Updated: 5 August, 2025   |   ClinicalTrials.gov

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Trial Details

  • Phase 2/Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 75

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Drug: Iza-bren
Experimental: Arm B
Drug: Iza-bren
Active Comparator: Arm C
Drug: Cisplatin, Gemcitabine, Carboplatin
Experimental: Arm D
Drug: Iza-bren
Active Comparator: Arm E
Drug: Cisplatin, Gemcitabine, Carboplatin

Key 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.

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