Izalontamab Brengitecan for Breast Cancer

Recruiting at 216 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bristol-Myers Squibb

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

560 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with triple-negative breast cancer that's advanced, can't be removed by surgery, or has spread. It's specifically for those who can't have anti-PD(L)1 drugs and hormone treatments. Participants should not have had prior treatment for their metastatic condition.

Inclusion Criteria

I can't have first-line chemotherapy with anti-PD-1 or anti-PD-L1 for my TNBC.

Has a severe auto-immune disease or other contraindication

Measurable disease by CT or MRI as per RECIST v1.1

Treatment Details

Interventions

• Capecitabine
• Carboplatin plus Gemcitabine
• Izalontamab Brengitecan
• Nab-paclitaxel
• Paclitaxel

Trial Overview The study compares the effectiveness of a new drug called Iza-bren against standard chemotherapy options like paclitaxel and carboplatin. Iza-bren targets specific proteins on cancer cells to deliver its treatment directly to them.

Participant Groups

Group I: Arm A2 Experimental Treatment 1 Intervention

Group II: Arm A1 Experimental Treatment 1 Intervention

Group III: Arm B Active Control 5 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

SystImmune Inc.

Industry Sponsor

Trials

23

Recruited

1,800+