BMS-986507 Combinations for Lung Cancer

Recruiting at 68 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: CNS metastases, Heart disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

238 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMS-986507, for individuals with advanced solid tumors, such as certain types of lung and breast cancer. Researchers aim to assess the safety, effectiveness, and behavior of this treatment in the body. The trial includes different groups: one for specific lung cancer mutations, another for more general advanced lung cancer, and one for certain types of breast cancer. Ideal candidates have a measurable tumor and a life expectancy of at least three months. Participants should not have a history of severe infections or heart disease. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

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

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

Research has shown that the treatment BMS-986507, also known as izalontamab brengitecan, generally has a well-tolerated safety profile, with acceptable side effects. In one study, 44.1% of advanced cancer patients responded to the treatment, indicating effectiveness for many participants.

Although detailed safety data from human trials for BMS-986507 remains limited, its testing in both early and later trial phases suggests it has passed initial safety checks, often indicating that serious side effects are uncommon. Prospective trial participants should discuss potential side effects and benefits with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for lung cancer, which typically involve chemotherapy, targeted therapy, or immunotherapy, BMS-986507 offers a novel approach. Researchers are excited about this treatment because it may work by targeting a new pathway or mechanism not addressed by existing therapies. This could potentially lead to improved outcomes for patients who do not respond well to current options, offering hope for a more effective and personalized treatment strategy.

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

Research has shown that BMS-986507, also known as izalontamab brengitecan, yields promising results in treating certain cancers. In studies with patients who had advanced bladder cancer, nearly half experienced tumor shrinkage. Additionally, in 88.2% of these patients, the cancer did not progress. These findings suggest that BMS-986507 could effectively treat advanced solid tumors, including lung cancer. In this trial, participants will join one of the experimental groups to receive BMS-986507. This treatment combines an antibody with chemotherapy, targeting specific cancer cells to deliver chemotherapy directly, aiming for greater effectiveness with less harm to healthy cells. ^{1 2 3 4 6}

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 adults with advanced solid tumors, which can include various types of cancer that have spread beyond their original location. Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have tried other treatments first.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Participants must have at least one measurable lesion per response evaluation criteria in solid tumors

Participants must have a life expectancy of at least 3 months at the time of the first dose

Exclusion Criteria

My lung cancer is not a mix of SCLC and NSCLC types.

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have a history of severe heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986507 combinations to evaluate safety, tolerability, drug levels, and preliminary efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986507

Trial Overview The study is testing the safety and effectiveness of combining a new drug called BMS-986507 with Osimertinib and Pembrolizumab in treating advanced cancers. It will look at how well patients tolerate the combination therapy and measure its impact on their tumors.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 2 Interventions

Group II: Group B Experimental Treatment 2 Interventions

Group III: Group A Experimental Treatment 2 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

Citations

1. news.bms.com news.bms.com/news/corporate-financial/2025/Izalontamab-Brengitecan-EGFRxHER3-ADC-Granted-Breakthrough-Therapy-Designation-by-U-S--FDA-for-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer/default.aspx

Izalontamab Brengitecan (EGFRxHER3 ADC) Granted ... The FDA's decision was based on efficacy and safety data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203, conducted in China ...

2. onclive.com onclive.com/view/izalontamab-brengitecan-data-reinforce-the-value-of-adcs-in-advanced-urothelial-carcinoma

Izalontamab Brengitecan Data Reinforce the Value of ... Izalontamab brengitecan showed a 44.1% objective response rate and 88.2% disease control rate in advanced urothelial carcinoma patients. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07100080

Study of Izalontamab Brengitecan (BMS-986507) Versus ... IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With ...

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

News SystImmune, Inc. to Present New Clinical Data on Izalontamab Brengitecan and BL-M07D1 Highlighting Strength of Differentiated Antibody Drug ...

5. oncologypipeline.com oncologypipeline.com/apexonco/esmo-2025-iza-brens-us-backing-comes-toxicity

ESMO 2025 – iza-bren's US backing comes with toxicity The trial, described as iza-bren's first global study to yield data, mostly concerned lung cancer, plus several other heavily pretreated tumours ...

6. adcreview.com adcreview.com/conference-coverage/esmo/esmo-2025-first-global-phase-i-results-of-izalontamab-brengitecan-in-patients-with-advanced-solid-tumors/

ESMO 2025: First Global Phase I Results of Izalontamab ... The US-Lung-101 study (NCT05983432), a global, multi-center, phas 1 study, evaluated the safety and efficacy of Izalontamab Brengitecan in ...