A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment
Sponsor: Bristol-Myers Squibb
This observational or N/A phase trial investigates Breast Neoplasms and is currently actively recruiting participants. Bristol-Myers Squibb leads this study, which shows 12 recorded versions since 2025 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Status Flow
Change History
12 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE2/PHASE3 → None
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Mar 2026 — May 2026 [monthly]
Recruiting PHASE2/PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE2/PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE2/PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE2/PHASE3
▶ Show 7 earlier versions
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE2/PHASE3
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE2/PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE2/PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2/PHASE3
Status: Not Yet Recruiting → Recruiting
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Jul 2025 — Aug 2025 [monthly]
Not Yet Recruiting PHASE2/PHASE3
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Jun 2025 — Jul 2025 [monthly]
Not Yet Recruiting PHASE2/PHASE3
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May 2025 — Jun 2025 [monthly]
Not Yet Recruiting PHASE2/PHASE3
First recorded
Eligibility Summary
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Contact Information
- Bristol-Myers Squibb
- SystImmune Inc.
For direct contact, visit the study record on ClinicalTrials.gov .