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Clinical Trials in India / NCT06926868
Recruiting Phase 2/Phase 3

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)

NCT06926868 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/Phase 3
Started
2025-09-11
Last updated
2026-08-10

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Iza-brenNab-paclitaxelPaclitaxelCapecitabineCarboplatinGemcitabine

Iza-bren: Specified dose on specified days

Nab-paclitaxel: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Capecitabine: Specified dose on specified days

Carboplatin: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * 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: i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (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, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day). v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication. vii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases. * 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 Criteria * 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: i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion). ii) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months. iii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block. iv) Known LVEF \< 50%. * Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (295)

FacilityCityRegionStatus
Local Institution - 0303 Hot Springs Arkansas Not Yet Recruiting
Helios Clinical Research Cerritos California Recruiting
Local Institution - 0307 Cerritos California Withdrawn
Local Institution - 0308 Cerritos California Withdrawn
Local Institution - 0309 Cerritos California Withdrawn
Local Institution - 0311 Long Beach California Withdrawn
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
USC Norris Oncology/Hematology-Newport Beach Newport Beach California Recruiting
Local Institution - 0358 Stanford California Not Yet Recruiting
Local Institution - 0289 Aurora Colorado Not Yet Recruiting
Rocky Mountain Cancer Centers Denver Colorado Recruiting
Medical Oncology Hematology Consultants, PA Newark Delaware Recruiting
Local Institution - 0296 Pembroke Pines Florida Not Yet Recruiting
Local Institution - 0294 Atlanta Georgia Completed
Northside Hospital Atlanta Georgia Recruiting
Local Institution - 0278 Chicago Illinois Withdrawn
Local Institution - 0280 Chicago Illinois Not Yet Recruiting
Decatur Memorial Hospital Decatur Illinois Recruiting
Local Institution - 0324 O'Fallon Illinois Withdrawn
Ochsner Clinic Foundation Covington Louisiana Recruiting
Local Institution - 1035 Baltimore Maryland Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion) Detroit Michigan Recruiting
Minnesota Oncology Hematology Maple Grove Minnesota Recruiting
Local Institution - 0372 Minneapolis Minnesota Not Yet Recruiting
Saint Luke's Cancer Institute Kansas City Missouri Recruiting
Local Institution - 0312 New York New York Withdrawn
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Local Institution - 1037 Syracuse New York Not Yet Recruiting
Clinical Research Alliance Westbury New York Recruiting
White Plains Hospital White Plains New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Willamette Valley Cancer Institute Eugene Oregon Recruiting
Lehigh Valley Health Network Allentown Pennsylvania Recruiting
Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania Recruiting
Local Institution - 0360 Pittsburgh Pennsylvania Not Yet Recruiting
St Francis Cancer Center Greenville South Carolina Recruiting
Texas Oncology - Central/South Texas Austin Texas Recruiting

+ 255 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06926868 on ClinicalTrials.gov ↗ ← All trials in India