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Also known as BMS-986507, BL-B01D1, Izalontamab brengitecan, BL-BO1D1
Iza-bren · 5 trials · 5 indications
Phase 2
Phase 3
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Arm C | ACTIVE_COMPARATOR | - |
| Arm D | EXPERIMENTAL | - |
| Arm E | ACTIVE_COMPARATOR | - |
| Arm A1 | EXPERIMENTAL | - |
| Arm A2 | EXPERIMENTAL | - |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Group D | EXPERIMENTAL | - |
| Group E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Iza-bren | DRUG | Specified dose on specified days |
| Osimertinib | DRUG | Specified dose on days |
| Pemetrexed | DRUG | Specified dose on specified days |
| Carboplatin | DRUG | Specified dose on specified days |
| Cisplatin | DRUG | Specified dose on specified days |
| Gemcitabine | DRUG | Specified dose on specified days |
| Nab-paclitaxel | DRUG | Specified dose on specified days |
| Paclitaxel | DRUG | Specified dose on specified days |
| Capecitabine | DRUG | Specified dose on specified days |
| BMS-986507 | DRUG | Specified dose on specified days |
| Pembrolizumab | DRUG | Specified dose on specified days |
| Nivolumab | DRUG | Specified dose on specified days |
| Pumitamig | DRUG | Specified dose on specified days |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatmen...
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Iza-bren is an investigational oncology therapy being studied in breast neoplasms, non-small cell lung cancer, and urothelial cancer. Clinical trials are evaluating it in triple-negative breast cancer, EGFR-mutated non-small cell lung cancer, and metastatic urothelial cancer that has progressed after immunotherapy. It is not yet approved for any indication.
Iza-bren is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is running the clinical development program, including the IZABRIGHT series of trials in lung cancer, breast cancer, and urothelial cancer across North America, Europe, and Asia.
Iza-bren is in Phase 2 development, with individual trials spanning Phase 2 and Phase 3. Two active trials are currently recruiting, and no trials have been completed. The program has enrolled approximately 1,350 participants across randomized, active-controlled studies. Iza-bren is investigational and has not received FDA approval.
Iza-bren is being studied in four recruiting trials: NCT07680790 (IZABRIGHT-Lung02) in EGFR-mutated non-small cell lung cancer, NCT07100080 (IZABRIGHT-Lung01) in EGFR-mutated NSCLC after EGFR TKI failure, NCT07106762 in metastatic urothelial cancer, and NCT06926868 (IZABRIGHT-Breast01) in triple-negative breast cancer.
Yes, Iza-bren is an alternative name for izalontamab brengitecan, which is also identified by the code BMS-986507. All three names refer to the same investigational agent being developed by Bristol-Myers Squibb for breast neoplasms, non-small cell lung cancer, and urothelial cancer.
The Iza-bren clinical program has a total planned enrollment of approximately 1,350 participants across its active trials. The largest is NCT07680790 with 850 participants, followed by NCT06926868 with 600, NCT07100080 with 500, and NCT07106762 with 470. All trials are randomized and actively controlled.