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Looking for participantsPhase2/Phase3

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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06926868

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Iza-bren (drug), Nab-paclitaxel (drug), Paclitaxel (drug), Capecitabine (drug)
How long the study runs
Study runs about 56 months (dates as stated)
About the drug or intervention
Iza-bren — 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 · Carboplatin — drug: Specified dose on specified days · Gemcitabine — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor

In plain English

This study compares a drug called izalontamab brengitecan with chemotherapy in people with a type of breast cancer known as triple-negative breast cancer, or a similar 'ER-low, HER2-negative' type. The cancer must be locally advanced, come back after treatment, or have spread, and must not be suitable for treatment with anti-PD-1 or anti-PD-L1 immunotherapy drugs. Participants must not have had any drug treatment for this stage of their cancer before.

Who can take part

  • Confirmed locally advanced, recurrent inoperable, or metastatic (spread) triple-negative breast cancer, or ER-low, HER2-negative breast cancer, based on a recent biopsy or tissue sample
  • If the cancer came back, this must have been at least 6 months after finishing the last treatment given with the aim of curing it
  • People with triple-negative breast cancer must not be able to have immunotherapy drugs such as pembrolizumab or atezolizumab, for example because their cancer tested negative for PD-L1, their cancer came back 6 to 12 months after earlier immunotherapy, or they have a severe autoimmune disease or other reason these drugs are unsuitable
  • People with ER-low, HER2-negative breast cancer must not be suitable for hormone (endocrine) therapy
  • No previous drug treatment (systemic therapy) for the advanced or spread stage of the cancer
  • Cancer that can be measured on a CT or MRI scan

Who may not be able to

  • People with an inherited BRCA1 or BRCA2 gene change whose doctors believe a PARP inhibitor treatment is the best first option for them
  • Untreated cancer spread to the brain or spinal cord causing symptoms (people may join if this has been treated and they have recovered, with scans showing stability and stable or low steroid doses)
  • Cancer spread to the membranes around the brain and spinal cord (leptomeningeal metastases)
  • Serious heart problems, for example heart failure, a heart attack, uncontrolled angina or stroke in the past 6 months, certain irregular heart rhythms on an ECG, or a known heart pumping strength (LVEF) below 50%
  • Previous treatment with izalontamab brengitecan or similar antibody-drug treatments targeting EGFR or HER3, or containing a topoisomerase 1 inhibitor
  • Other criteria in the full trial protocol also apply — ask the trial team

What taking part involves

  • • Being given either the study drug izalontamab brengitecan or chemotherapy
  • • CT or MRI scans to measure the cancer

Time commitment: Not stated — ask the trial team about how long the trial lasts, how often visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2025-09-11
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Phase2/Phase3 - 600 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • Truro - Local Institution - 0208
  • • London - Local Institution - 0004
  • • London - Local Institution - 0204
  • • London - Local Institution - 0209
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Breast Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

ERHER2ISH negativePD-L1L1 negativePDL1EGFR

Treatment history

Treatments you must have had:

  • ✓ current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day)
  • ✓ immunosuppression
  • ✓ iza-bren

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last...
  • ✓v) Prior auto-immune AE to peri-after surgery ICI that required immunosuppression. vi) Current Graves' disease with...
  • ✓Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine...
  • ✓No previous treatment that goes through your whole body in the that has grown locally, recurrent inoperable or that has spread setting (ie incurable setting).
See the full criteria
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.

Where Is This Study? (7 UK sites)

Local Institution - 0208

Truro TR1 3LJ, United Kingdom

ACTIVE_NOT_RECRUITING

Local Institution - 0004

London EC1A 7BE, United Kingdom

ACTIVE_NOT_RECRUITING

Local Institution - 0204

London SE1 9RT, United Kingdom

WITHDRAWN

Local Institution - 0209

London SE1 9RT, United Kingdom

ACTIVE_NOT_RECRUITING

Local Institution - 0171

Belfast BT9 7AB, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0001

Manchester M20 4BX, United Kingdom

ACTIVE_NOT_RECRUITING

Local Institution - 0006

Nottingham NG5 1PB, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-07