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Clinical trial

A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy

NCT07869836 is registered in ClinicalTrials.gov with SystImmune Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy
Lead sponsor
SystImmune Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
September 30, 2026
Completion date
December 31, 2029
Enrollment
520 (estimated)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

bladder (urothelial, transitional cell) cancer, bladder (urothelial, transitional cell) cancer metastatic or unresectable, bladder ca, bladder cancer, bladder cancer (bc), bladder cancer recurrent, bladder cancer stage iv, metastatic urothelial cancer, urothelial cancer, urothelial carcinoma bladder, urothelial carcinoma of the urinary bladder, urothelial carcinoma recurrent