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Izalontamab brengitecan versus chemotherapy for first-line metastatic triple-negative or ER-low, HER2-negative breast cancer in patients not eligible for anti-PD(L)1 drugs

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

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT06926868

This trial tests whether iza-bren (izalontamab brengitecan), a bi‑specific antibody‑drug conjugate, works better than standard chemotherapy as first-line treatment for people with metastatic triple‑negative or ER‑low, HER2‑negative breast cancer who cannot receive anti‑PD(L)1 drugs.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionschemotherapy
Locations294 sites (Hot Springs, Arkansas and 293 other locations)
Trial IDNCT06926868 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 interventional trial compares iza-bren, a bi‑specific ADC targeting EGFR and HER3 with a topoisomerase inhibitor payload, against physician's choice chemotherapy (paclitaxel, nab‑paclitaxel, carboplatin plus gemcitabine, or capecitabine) as first-line therapy. Eligible participants are adults with locally advanced, recurrent inoperable, or metastatic triple‑negative breast cancer or ER‑low, HER2‑negative disease who are not candidates for anti‑PD(L)1 therapy. Participants will be assigned to receive iza-bren or one of the standard chemotherapy options and followed for tumor response, progression, and treatment-related safety outcomes. The study aims to determine whether iza-bren can improve outcomes compared with standard chemotherapy in this specific patient population.

Who should consider this trial

Good fit: Adults with histologically confirmed locally advanced, recurrent inoperable, or metastatic triple‑negative breast cancer (ER <1%, PgR <1%, HER2 negative) or ER‑low (1–10%) HER2‑negative breast cancer who have not received prior systemic therapy for metastatic disease and are ineligible for anti‑PD(L)1 therapy are ideal candidates.

Not a fit: Patients with HER2‑positive tumors, those who have already received systemic therapy for metastatic disease, or those who are eligible for anti‑PD(L)1 therapies are unlikely to match the intended population for this trial and may not benefit.

Why it matters

Potential benefit: If successful, iza-bren could offer a more effective first-line treatment option than standard chemotherapy for patients with metastatic TNBC or ER‑low, HER2‑negative disease who cannot receive anti‑PD(L)1 drugs.

How similar studies have performed: Other antibody‑drug conjugates, such as sacituzumab govitecan, have shown meaningful benefit in metastatic TNBC, but bi‑specific EGFR/HER3 ADCs like iza‑bren are a newer approach with more limited clinical experience so far.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:

  i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.
* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
* Measurable disease by CT or MRI as per RECIST v1.1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Hot Springs, Arkansas and 293 other locations

+244 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Neoplasmstriple-negative breast cancerantibody-drug conjugateER-low/HER2-negative breast cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.