Izalontamab Brengitecan for Breast Cancer

Recruiting at 389 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

Must not be taking: Anti-PD(L)1, Endocrine therapies

Disqualifiers: Severe autoimmune disease, others

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: Unknown

Duration: 31 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called iza-bren (Izalontamab Brengitecan) for certain types of advanced breast cancer. It targets individuals with triple-negative breast cancer (TNBC) or a specific kind of estrogen receptor-low, HER2-negative breast cancer who cannot use other common therapies. The study compares iza-bren to standard treatments like paclitaxel or capecitabine. Suitable participants have breast cancer that cannot be surgically removed or has spread, and their cancer returned at least six months after their last treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Izalontamab Brengitecan, a type of targeted cancer treatment, is being tested for safety and effectiveness in treating certain types of breast cancer. In earlier studies, patients generally tolerated the treatment well. Most side effects were mild to moderate, including nausea, tiredness, and low blood cell counts, which are common with many cancer treatments.

The trial's advanced stage suggests that earlier studies provided some evidence of the treatment's safety in humans. However, this does not eliminate all risks. It is important to consult with a doctor to determine if joining a trial is appropriate.

Why are researchers excited about this trial's treatments?

Researchers are excited about Izalontamab Brengitecan because it offers a novel approach to treating breast cancer. Unlike typical chemotherapy drugs that indiscriminately attack fast-growing cells, Izalontamab Brengitecan targets specific cancer cells with a unique mechanism of action. This targeted approach not only aims to be more effective in attacking cancer cells but also has the potential to reduce the side effects commonly associated with traditional chemotherapy treatments. Additionally, by focusing on specific proteins found on cancer cells, Izalontamab Brengitecan may improve outcomes for patients who haven't responded well to other treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that izalontamab brengitecan, or iza-bren, yields promising results in treating breast cancer. In one study, 42.1% of patients experienced tumor shrinkage or disappearance, while 80.2% had stable cancer, meaning it did not worsen. In this trial, some participants will receive iza-bren, a treatment that targets two proteins (EGFR and HER3) on cancer cells and delivers chemotherapy directly to the tumor. This targeted approach may kill cancer cells more effectively while sparing healthy ones. These findings suggest iza-bren could be a promising treatment for certain breast cancer patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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

Has a severe auto-immune disease or other contraindication

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either iza-bren or treatment of physician's choice for first-line metastatic TNBC or ER-low, HER2-negative BC

31 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

In a study involving 55 women with metastatic breast cancer, the combination of weekly paclitaxel and capecitabine resulted in a 55% objective response rate, indicating significant antitumor activity as a first-line treatment.

The treatment was generally tolerable, with a clinical benefit rate of 65% and a median duration of response of 10 months, although some patients experienced notable side effects like hand-foot skin reactions and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer. Blum, JL., Dees, EC., Chacko, A., et al.[2015]

Current cytotoxic therapies for metastatic breast cancer show low response rates, and resistance to these treatments is almost always developed, whether initially or over time.

There is a critical need for new therapies that can improve overall survival in patients who have developed resistance to standard treatments like anthracyclines and taxanes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Other options in the treatment of advanced breast cancer. Cobleigh, MA.[2019]

Citations

1.

onclive.com

onclive.com/view/iza-bren-shows-preliminary-efficacy-safety-in-heavily-pretreated-her2-her2-low-breast-cancer

Iza-Bren Shows Preliminary Efficacy, Safety in Heavily ...

Izalontamab brengitecan demonstrated a 42.1% overall response rate and 80.2% disease control rate in heavily pretreated HER2-negative or HER2- ...

2.

systimmune.com

systimmune.com/news---systimmune-inc-to-present-updated-izalontamab-brengitecan-iza-bren-data-in-locally-advanced-or-metastatic-breast-cancer-at-esmo-breast-2025

News - SystImmune, Inc. to Present Updated izalontamab ...

Updated safety & efficacy in Locally Advanced or Metastatic Breast Cancer will be presented from a Ph1 clinical study evaluating iza-bren.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06926868

NCT06926868 | A Study of Izalontamab Brengitecan ...

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 ...

4.

prnewswire.com

prnewswire.com/news-releases/systimmune-inc-to-present-new-clinical-data-on-izalontamab-brengitecan-and-bl-m07d1-highlighting-strength-of-differentiated-antibody-drug-conjugate-adc-platform-302564945.html

SystImmune, Inc. to Present New Clinical Data ...

Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal ...

5.

targetedonc.com

targetedonc.com/view/izalontamab-brengitecan-earns-fda-breakthrough-designation-in-egfr-nsclc

Izalontamab Brengitecan Earns FDA Breakthrough ...

Promising efficacy and safety data from ongoing clinical trials support iza-bren's potential in improving outcomes for EGFR-mutant NSCLC ...