BMS-986460 for Healthy Subjects

Recruiting at 1 trial location

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

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Heart disease, Cardiac arrhythmias, Anaphylaxis, others

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

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986460, to determine its safety and absorption in the body. It targets healthy adult males to help researchers understand different forms of the drug. The trial includes multiple groups to explore these various formulations. Healthy men without a history of heart issues or severe allergic reactions, and who meet specific health criteria, are suitable candidates for the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility. Please consult with the trial coordinator for specific guidance.

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

Research has shown that BMS-986460 remains in the early testing stages. In these studies, researchers examine how well people tolerate the drug and identify potential side effects. As a Phase 1 trial, the goal is to identify common and serious side effects.

Previous trials with BMS-986460 have mostly involved healthy volunteers. These studies aim to detect any unwanted effects from the treatment and understand how the drug functions in the body.

Currently, the safety information is limited. While some data suggests BMS-986460 is generally well-tolerated, further research is necessary to confirm its safety for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-986460 because it introduces a novel mechanism of action that sets it apart from current treatments for immune-related conditions. While many existing therapies focus on broadly suppressing the immune system, BMS-986460 targets specific pathways to modulate immune response more precisely, potentially reducing side effects. Additionally, its innovative approach could offer quicker onset of action, providing relief faster than traditional options. This precision and speed make BMS-986460 a promising candidate in the field of immunotherapy.

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

Research is investigating BMS-986460 as a potential treatment for conditions such as advanced prostate cancer that resists standard hormone therapy. Early studies have primarily assessed its safety and patient tolerance. So far, BMS-986460 appears manageable for patients, which is promising. However, detailed information about its effectiveness for specific conditions remains limited. BMS-986460 targets certain pathways in cancer cells, suggesting potential effectiveness, but further research is necessary to confirm this. Participants in this trial will receive different sequences or treatments of BMS-986460 to further evaluate its safety and potential effectiveness. ^{1 6 7 8 9}

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 healthy adult men who can participate in a study to test different forms of a drug called BMS-986460. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive

I agree to use birth control if I'm sexually active with someone who can get pregnant.

I am generally healthy with no significant medical issues.

Exclusion Criteria

Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded

Other protocol-defined Inclusion/Exclusion criteria apply

Participants with history of anaphylactic reactions are excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Treatment

Evaluation of relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants

4 weeks

Part 2: Single Ascending Dose Study

Evaluation of safety, tolerability, and pharmacokinetics of BMS-986460 in healthy adult male participants

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986460

Trial Overview The study is testing the safety and how the body absorbs different versions of BMS-986460. It's a single-dose trial, meaning each participant will receive one dose of the medication to evaluate its effects.

How Is the Trial Designed?

Group I: Part 2: Treatment B Experimental Treatment 1 Intervention

Group II: Part 2: Treatment A Experimental Treatment 1 Intervention

Group III: Part 2: Optional Treatment E Experimental Treatment 1 Intervention

Group IV: Part 2: Optional Treatment D Experimental Treatment 1 Intervention

Group V: Part 2: Optional Treatment C Experimental Treatment 1 Intervention

Group VI: Part 1: Sequence 3 Experimental Treatment 1 Intervention

Group VII: Part 1: Sequence 2 Experimental Treatment 1 Intervention

Group VIII: Part 1: Sequence 1 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

BMS-986001 was found to be safe and well tolerated in a study involving 64 healthy male subjects, with no serious adverse events reported and only 14.6% experiencing mild adverse effects that were not dose-related.

The pharmacokinetics of BMS-986001 showed a linear dose-exposure relationship, indicating consistent absorption and effectiveness across various doses, regardless of whether it was taken with or without food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects. Urata, Y., Paintsil, E., Cheng, YC., et al.[2014]

In a study involving 34 patients with advanced solid tumors, the maximum tolerated dose (MTD) of BMS-184476 was determined to be 60 mg/m2, with significant dose-limiting toxicities observed at higher doses, including severe neutropenia and diarrhea.

BMS-184476 demonstrated preliminary activity, with one patient showing a partial response and another a minor response, suggesting potential advantages over paclitaxel in terms of safety and pharmacokinetics, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. Hidalgo, M., Aylesworth, C., Hammond, LA., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06067841

NCT06067841 | A Study to Assess BMS-986460 in ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2-2025-d5d2e

BMS-986460 for Healthy Subjects This Phase 1 medical study run by Bristol-Myers Squibb is evaluating whether BMS-986460 will have tolerable side effects & efficacy for patients with ...

3. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q3-Results-Investor-Presentation-with-Appendix.pdf

Q3 2025 Results Presentation (with Appendix) This presentation contains statements about Bristol-Myers Squibb Company's (the. “Company”) future financial results, plans, ...

4. dana-farber.org dana-farber.org/clinical-trials/24-010

A Phase 1, Open-label Study of BMS-986460 in ... The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate ...

5. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q1-Results-Investor-Presentation-with-Appendix.pdf

Q1 2025 Results This presentation contains statements about Bristol-Myers Squibb Company's (the. “Company”) future financial results, plans, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06067841

A Study to Assess BMS-986460 in Participants With ... They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...

7. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06877702

Trial ID CA125-1018 | NCT06877702 - BMS Clinical Trials The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/587315

A Single-dose Study to Evaluate the Safety, Tolerability, Drug ... The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy ...

9. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-bms-986460-in-participants-with-metastatic-castration-resistant-prostate-cancer

A Study to Assess BMS-986460 in Participants With Metastatic ... The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration- ...