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A Study of Izalontamab Brengitecan for Triple-Negative Breast Cancer

This study is testing a new treatment called iza-bren for people with advanced triple-negative breast cancer (TNBC) or a similar type of breast cancer (ER-low, HER2-negative BC). You might be able to join if your cancer has spread or come back, and you can't take certain other common treatments. Researchers want to see if iza-bren is safer and works better than standard chemotherapy drugs like paclitaxel, nab-paclitaxel, capecitabine, or carboplatin. The main goal is to see how long people live without their cancer growing or spreading. This study aims to enroll about 500 participants.

Study design
This is an interventional study comparing iza-bren to standard chemotherapy treatments. It plans to enroll 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome will be measured approximately 31 months after the first participant starts treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06926868

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~600 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Iza-brenNab-paclitaxelPaclitaxelCapecitabineCarboplatinGemcitabine

At a glance

Recruiting sites
168 of 295 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Approximately 22 months from first participant randomization in Phase 3
+1 more outcome measured

Conditions

Breast Neoplasms

Explore related trials

ER-low/HER2-negative Breast CancerTriple-Negative Breast CarcinomaPGR Gene

Where it's being run

295 sites across 172 states
California9
Japan7
Germany6
Romania6
New York5
Argentina5
Italy5
Tokyo5

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (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 American Society of Clinical Oncology/College of American Pathologists (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.
Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria:
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.

Exclusion

Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi).
Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.
Leptomeningeal metastases.
Participants with history of severe heart disease including, but not limited to, any of the following:
Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.

What this trial measures

  • Progression-Free Survival (PFS)Approximately 22 months from first participant randomization in Phase 3

    Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

  • Recommended Phase 3 Dose (RP3D) of BMS-986507Approximately 13 months from first participant randomization in Phase 2