CA244-0012 (IZABRIGHT-Bladder01): Phase 2/3 study of Izalontamab Brengitecan in Urothelial Cancer

• Research type

  Research Study

• Full title

  IZABRIGHT-Bladder01: A randomized, open-label, Phase 2/3 trial of izalontamab brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment

• IRAS ID

  1012687

• Contact name

  GSMCT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb Services Unlimited Company

• Eudract number

  2025-522400-24

• Research summary

  IZABRIGHT-Bladder 01 (CA244-0012) is a global clinical trial testing the effectiveness of Izalontamab Brengitecan (BMS-9865507, iza-bren) in patients living with advanced bladder cancer (metastatic urothelial carcinoma) whose disease has worsened after prior immunotherapy treatment. Approx. 470 patients will take part in the study globally, including the UK.
  The study has three parts (screening, treatment and follow-up) and two stages (phase 2 and phase 3).
  In Phase 2, two doses of iza-bren will be compared against each other to find the optional dose. Participants will be randomly assigned to one of three groups: Arm A (iza-bren at a dose level 1) Arm B (iza-bren at a dose level 2) or Arm C (PBC - cisplatin/carboplatin + gemcitabine for up to 6 cycles). Once enough participants have completed this phase, the best dose of iza-bren will be selected and the study will move to Phase 3.

  In Phase 3, the optimal dose of iza-bren chosen in Phase 2 will be compared to platinum-based chemotherapy (PBC) to confirm if iza-bren works better than PBC in patients who have not responded to other treatments. Participants will be randomly assigned to one of two groups: Arm D (Iza-bren, dose selected in Phase 2) or Arm E (PBC - cisplatin/carboplatin + gemcitabine for up to 6 cycles).

  Participants (18 years or older) will receive treatment until the cancer progresses, side effects become too severe or a maximum of 6 cycles of PBC have been completed. After stopping treatment, participants will be monitored in-person for side effects for about 30 days and then contacted remotely every 12 weeks for long-term follow-up. Total study duration is expected to be a maximum of approx. 5 years for a participant.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  25/NS/0111

• Date of REC Opinion

  15 Oct 2025

• REC opinion

  Further Information Favourable Opinion