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)

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 3; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Paclitaxel; Drug: Iza-bren; Drug: Capecitabine; Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926868

2024-519871-24 (Other Identifier)

U1111-1316-1533 (Other Identifier)

CA244-0008

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 FISH 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 FISH 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:.
• Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
• Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 3 patient groups

Arm A1

Experimental group

Treatment:

Drug: Iza-bren

Arm A2

Experimental group

Treatment:

Drug: Iza-bren

Arm B

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Capecitabine

Drug: Paclitaxel