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)
| NCT ID | NCT06926868 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2028-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2025-09-11 with a primary completion date of 2028-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06926868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926868 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06926868 currently recruiting?
Yes, NCT06926868 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06926868 trial being conducted?
This trial is being conducted at Hot Springs, United States, Cerritos, United States, Cerritos, United States, Cerritos, United States and 11 additional locations.
Who is sponsoring the NCT06926868 clinical trial?
NCT06926868 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 500 participants.