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.
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.
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).
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.
Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.
Parallel
Iza-bren
DrugSpecified dose on specified days
Nab-paclitaxel
DrugSpecified dose on specified days
Paclitaxel
DrugSpecified dose on specified days
Capecitabine
DrugSpecified dose on specified days
Carboplatin
DrugSpecified dose on specified days
Gemcitabine
DrugSpecified dose on specified days
Progression-Free Survival (PFS)
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-986507
Overall Survival (OS)
Number of participants with treatment-related Adverse Events (AEs)
Number of participants with laboratory abnormalities
Number of participants with serious AEs (SAEs)
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Bristol-Myers Squibb
Lead sponsor
SystImmune Inc.
Collaborator