Izalontamab Brengitecan for Breast Cancer

Recruiting at 220 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

560 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Izalontamab Brengitecan for breast cancer?

Research shows that capecitabine, a component of the treatment, has been effective in treating metastatic breast cancer, especially in patients who have been pretreated with other drugs like paclitaxel. Studies have demonstrated that capecitabine, when combined with other drugs, can be active and safe for patients with advanced breast cancer. ^{1 2 3 4 5}

What safety data exists for Izalontamab Brengitecan and related treatments in humans?

The safety data for treatments related to Izalontamab Brengitecan, such as Capecitabine, Carboplatin, and Gemcitabine, show that these drugs can be safely combined at certain doses, though they may cause side effects like neutropenia (low white blood cell count), diarrhea, and hand-foot syndrome (redness and swelling of the hands and feet). These side effects were generally mild, and no treatment-related deaths were reported in the studies. ^{6 7 8 9 10}

What makes the drug Izalontamab Brengitecan unique for breast cancer treatment?

Izalontamab Brengitecan is unique because it combines multiple chemotherapy agents, including capecitabine, carboplatin, gemcitabine, nab-paclitaxel, and paclitaxel, which are known for their individual effectiveness in breast cancer treatment. This combination may offer a novel approach by potentially enhancing the overall anti-tumor activity and overcoming resistance seen with other treatments. ^{10 11 12 13 14}

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

Timeline

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

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Capecitabine with weekly paclitaxel for advanced breast cancer: a phase I dose-finding trial. [2015]

2. Cyprus pubmed.ncbi.nlm.nih.gov

Capecitabine/cisplatin doublet in anthracycline and taxane pretreated and HER-2 negative metastatic breast carcinoma patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A dose escalation study of docetaxel plus capecitabine in combination with gemcitabine in patients with advanced solid tumors. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A feasibility study of weekly docetaxel with capecitabine in ovarian cancer: a promising combination of two active drugs with a potential for synergism. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Docetaxel followed by gemcitabine and irinotecan in solid tumors. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Capecitabine/Taxane combination therapy: evolving clinical utility in breast cancer. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). [2019]

14. England pubmed.ncbi.nlm.nih.gov

Capecitabine and vinorelbine in metastatic breast cancer. [2018]