BMS-986463 for Advanced Cancer

Recruiting at 22 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Leptomeningeal metastases, Concurrent malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986463 to determine its safety and effectiveness for individuals with advanced cancer that cannot be surgically removed or has metastasized. Researchers will assess how well different doses of this treatment work and how the body tolerates them. The trial seeks participants with a type of cancer that has spread and who can provide a biopsy sample (a small tissue sample for testing). As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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

The trial information does not specify if 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 BMS-986463 is likely to be safe for humans?

In a previous study, researchers examined how well people handled BMS-986463, a new treatment being tested for advanced cancer. As this study is in the early stages, limited information exists about its safety for humans. Early-stage trials focus on assessing safety and determining the right dose, rather than proving the treatment's effectiveness.

Early-stage trials often test different doses to find the optimal one without causing major side effects. Researchers are still learning how the treatment affects people. If the treatment had been used for other conditions, more safety information might be available. However, for BMS-986463, safety information is still being collected.

Joining a trial like this helps researchers learn more about the treatment's safety, which can sometimes involve unknown risks. Participants receive close monitoring to manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BMS-986463 is unique because it offers a new approach to treating advanced cancer by targeting specific pathways that current standard treatments might not address. While traditional cancer treatments like chemotherapy and radiation attack rapidly dividing cells indiscriminately, BMS-986463 focuses on inhibiting particular proteins or signals that cancer cells need to grow and survive. This targeted action not only aims to be more effective but also can potentially reduce side effects compared to conventional therapies. Researchers are excited about BMS-986463 because it represents a novel strategy that could improve outcomes for patients who may not respond well to existing treatments.

What evidence suggests that BMS-986463 might be an effective treatment for advanced cancer?

Research has shown that BMS-986463 targets specific processes that aid cancer cell growth. Early studies suggest it may block the signals tumors use to grow and spread. Although detailed information from human studies remains limited, the treatment has shown promise in lab tests. Scientists believe it could become an important part of cancer treatment, especially for hard-to-treat tumors. In this trial, participants will join one of two arms: Arm 1 focuses on dose escalation to find the optimal dose, while Arm 2 involves dose expansion to ensure safety for people. ^{1 2 3 6 7}

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 certain advanced cancers, including uterine, ovarian, non-small cell lung cancer, and serous cystadenocarcinoma. Participants should be able to receive escalating doses of the study drug.

Inclusion Criteria

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

I have a tumor that can be biopsied in addition to the main one.

My cancer cannot be removed by surgery and has spread.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have cancer spread to the lining of my brain and spinal cord.

I have no other cancers needing treatment or active cancers in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BMS-986463 to evaluate safety and tolerability

8-12 weeks

Dose Expansion

Participants receive expanded doses of BMS-986463 to further evaluate 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-986463

Trial Overview The focus of this study is on BMS-986463. It's given in increasing amounts to see how safe it is and how well it works against specific advanced cancers.

How Is the Trial Designed?

Group I: Arm 2: Dose Expansion Experimental Treatment 1 Intervention

Group II: Arm 1: Dose Escalation Experimental Treatment 1 Intervention

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

Published Research Related to This Trial

Combining BRAF inhibitors (BRAFi) like vemurafenib or dabrafenib with the BCL-2 inhibitor navitoclax shows promise in enhancing treatment outcomes for patients with BRAF mutant tumors, as it synergistically reduces cancer cell viability in laboratory models.

In a study of 34 samples from 17 patients, early changes in anti-apoptotic protein levels were observed after BRAFi treatment, suggesting that targeting these proteins could help delay resistance and improve tumor regression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. Frederick, DT., Salas Fragomeni, RA., Schalck, A., et al.[2022]

In a phase I study involving 11 patients with advanced solid tumors, the combination of navitoclax and erlotinib was found to have a manageable safety profile, with common side effects including diarrhea, nausea, and vomiting, but no maximum tolerated dose was established.

Despite the lack of objective responses, the combination treatment resulted in a disease control rate of 27%, indicating some patients experienced stable disease, although the overall antitumor activity was limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Tolcher, AW., LoRusso, P., Arzt, J., et al.[2018]

The BCL-2 antisense oligonucleotide (G3139) was generally well tolerated in a study of 35 patients with advanced cancer, although some experienced fatigue and temporary increases in liver enzymes at the highest dose of 6.9 mg/kg/day.

Pharmacokinetic analysis showed that G3139 reached steady-state plasma concentrations within 10 hours, but no major antitumor responses were observed; ongoing trials are now testing shorter infusion periods to potentially enhance its effectiveness alongside standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of BCL-2 antisense oligonucleotide (G3139) administered by continuous intravenous infusion in patients with advanced cancer. Morris, MJ., Tong, WP., Cordon-Cardo, C., et al.[2012]

Primary tumor cells from acute lymphoblastic leukemia (ALL) showed high sensitivity to BH3 mimetic drugs ABT-263 and ABT-199, leading to rapid apoptotic cell death, indicating their potential as effective treatments.

The study revealed that these ALL cells were Bcl-2 dependent, and the primary cell cultures were more sensitive and uniform in response to BH3 mimetics compared to established cell lines, suggesting a promising model for preclinical drug testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BH3 Inhibitor Sensitivity and Bcl-2 Dependence in Primary Acute Lymphoblastic Leukemia Cells. Alford, SE., Kothari, A., Loeff, FC., et al.[2018]

The Bcl-2 inhibitor ABT-737 showed significant tumor regression in some small cell lung cancer (SCLC) cell line xenografts, but only limited effectiveness in primary SCLC xenografts, suggesting that primary tumors may have lower Bcl-2 expression or different characteristics affecting treatment response.

Combining ABT-737 with etoposide significantly enhanced tumor growth inhibition in primary SCLC xenografts, indicating that combination therapies may improve treatment outcomes for patients with SCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of ABT-737, a selective inhibitor of BCL-2, in small cell lung cancer. Hann, CL., Daniel, VC., Sugar, EA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06476808

NCT06476808 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant ...

2. trial.medpath.com trial.medpath.com/clinical-trial/891d1af8e8fa8531/nct06476808-safety-tolerability-efficacy-bms-986463-advanced-malignant-tumors

A Study to Evaluate the Safety, Tolerability, and Efficacy of ... The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant ...

3. news.bms.com news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-to-Present-Data-at-ESMO-2025-Showcasing-Progress-of-Oncology-Portfolio-Across-Diverse-Tumor-Types/default.aspx

Bristol Myers Squibb to Present Data at ESMO® 2025 ... Data from more than 50 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 10 cancer types ...

4. trialx.com trialx.com/clinical-trials/listings/313937/a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-escalating-doses-of-bms-986463-in-participants-with-select-advanced-malignant-tumors/

A Study to Evaluate the Safety, Tolerability, and Efficacy of ... The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select ...

5. tipranks.com tipranks.com/news/company-announcements/bristol-myers-squibbs-new-study-on-bms-986463-a-potential-game-changer-in-oncology

Bristol-Myers Squibb's New Study on BMS-986463 ' The study aims to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with advanced malignant ...

6. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT06476808

study connect - BMS Clinical Trials The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with ...

7. investors.bms.com investors.bms.com/iframes/press-releases/press-release-details/2025/Bristol-Myers-Squibb-to-Present-Data-at-ASCO-2025-Highlighting-Differentiated-Research-Platform-of-Oncology-Treatments-and-Innovative-Research-Pipeline/default.aspx

Bristol Myers Squibb to Present Data at ASCO® 2025 ... Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data across its oncology portfolio and pipeline at the 2025 American Society of Clinical ...