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

Not Applicable

Not yet recruiting

• Conditions: Urothelial Cancer
• Interventions: Drug: Iza-bren; Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

• Registration Number: NCT07106762
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-10-22
• Primary Completion: 2029-01-26
• Study Completion: 2033-11-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Iza-bren	-
Arm B	Iza-bren	-
Arm C	Cisplatin	-
Arm C	Gemcitabine	-
Arm C	Carboplatin	-
Arm D	Iza-bren	-
Arm E	Cisplatin	-
Arm E	Gemcitabine	-
Arm E	Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507	Approximately 3 months
Phase 3: Progression-Free Survival (PFS)	Up to 5 years	Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3: Overall Survival (OS)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Phase 2: Objective Response (OR)	Up to 5 years	Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator
Phase 2: PFS	Up to 5 years	Assessed using RECIST v1.1 by investigator
Phase 2: Duration of Response (DOR)	Up to 5 years	Assessed using RECIST v1.1 by investigator
Phase 2: Time to Response (TTR)	Up to 5 years	Assessed using RECIST v1.1 by investigator
Phase 2: OS	Up to 5 years
Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration	Up to 5 years
Phase 2: Iza-bren total antibody concentration	Up to 5 years
Phase 2: Iza-bren Ed-04 payload concentration	Up to 5 years
Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)	Up to 5 years
Phase 2: Iza-bren trough observed concentration (Ctrough)	Up to 5 years
Phase 3: OR	Up to 5 years	As per RECIST v1.1 by BICR
Phase 3: DoR	Up to 5 years	As per RECIST v1.1 by BICR
Phase 3: TTR	Up to 5 years	As per RECIST v1.1 by BICR
Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale	Up to 5 years

Trial Locations

Locations (90)

Local Institution - 0167; 🇺🇸 Gilbert, Arizona, United States

Local Institution - 0162; 🇺🇸 Fullerton, California, United States

Local Institution - 0163; 🇺🇸 Sacramento, California, United States

Local Institution - 0139; 🇺🇸 Sacramento, California, United States

Local Institution - 0191; 🇺🇸 Edwards, Colorado, United States

Local Institution - 0193; 🇺🇸 Lexington, Kentucky, United States

Local Institution - 0195; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0168; 🇺🇸 Detroit, Michigan, United States

Local Institution - 0192; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0161; 🇺🇸 Columbus, Ohio, United States

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