BMS-986517 for Cancer

Recruiting at 22 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Untreated CNS metastases, Concurrent malignancy, Serious infections, Heart disease, others

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

Compensation: Varies

Number of Visits: 21

Duration: 3 weeks

315 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-986517, an experimental therapy, to determine its safety and tolerability in individuals with certain advanced solid tumors, such as lung or breast cancer. Researchers aim to understand how the body processes this treatment and identify potential side effects. The trial includes different groups, each testing the treatment in unique ways. Suitable participants have a confirmed diagnosis of advanced solid tumors that are either inoperable or have metastasized. As a Phase 1 trial, this research focuses on understanding the treatment's effects 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 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 BMS-986517 is likely to be safe for humans?

Research shows that BMS-986517 is being tested for safety and tolerability in people with solid tumors. As this is the first human trial, the main goal is to understand reactions to the treatment and identify any side effects.

Such studies are typically conducted early, so information may be limited. However, reaching this stage indicates that the treatment has demonstrated some safety in earlier tests.

In these early phases, the study is designed to closely monitor for possible side effects. Researchers carefully observe participants to ensure safety and promptly address any issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about BMS-986517 because it offers a new approach to treating cancer. Unlike standard treatments like chemotherapy and radiation, which target rapidly dividing cells, BMS-986517 works by specifically targeting cancer cell pathways, potentially reducing damage to healthy cells. This precision could lead to fewer side effects and better outcomes for patients. Additionally, BMS-986517's unique mechanism of action means it might be effective in cases where other treatments have failed, offering hope for more personalized and effective cancer care.

What evidence suggests that BMS-986517 might be an effective treatment for cancer?

Research has shown that BMS-986517 is a promising new treatment tested in this trial for its potential to help people with solid tumors. Participants will join different cohorts to evaluate the treatment's effects. BMS-986517 targets certain proteins that aid cancer growth, potentially slowing or stopping the spread of cancer cells. Although still in early stages, initial results suggest that BMS-986517 is safe and could be well-tolerated by patients. This could represent an important step forward in treating solid tumors if further studies confirm these findings. More information about its effectiveness will be available as the trial progresses. ^{1 3 5 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 clinical trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have a certain type and stage of cancer, be in good overall health aside from their cancer, and meet other specific medical requirements set by the study.

Inclusion Criteria

Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).

I can carry out all my usual activities without help.

My cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply.

I do not have a history of serious, repeated infections.

My brain metastases have been treated and I don't need immediate treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986517 as monotherapy to evaluate safety and tolerability

3 weeks

Up to Day 21

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986517

Trial Overview The trial is testing BMS-986517, which is a new treatment under investigation. As it's an open-label, first-in-human study, everyone involved knows they're getting the drug and it's being used on humans for the first time to check its safety and how well people can tolerate it.

How Is the Trial Designed?

Group I: Part 2: Cohort C Experimental Treatment 1 Intervention

Group II: Part 2: Cohort B Experimental Treatment 1 Intervention

Group III: Part 2: Cohort A Experimental Treatment 1 Intervention

Group IV: Part 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07160725

A Phase 1/2a, First-in-human, Study of BMS-986517 in ... A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment ...

2. tipranks.com tipranks.com/news/company-announcements/bristol-myers-squibbs-new-study-on-bms-986517-a-potential-game-changer-in-cancer-treatment

Bristol-Myers Squibb's New Study on BMS-986517 ' The study aims to evaluate the safety and tolerability of BMS-986517 in individuals with advanced solid tumors, marking a significant step in ...

3. bms.com bms.com/researchers-and-partners/in-the-pipeline.html

Pharmaceutical research and development pipeline Our pipeline is focused on research in therapeutic areas where we can accelerate the development of transformational, life-changing medicines for patients.

4. patlynk.com patlynk.com/trial/NCT07160725

BMS-986517 for Advanced Solid Tumors The main goal of this study is to determine if BMS-986517 is safe and well-tolerated when used by itself in people with these types of tumors. Understanding the ...

5. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q2-Results-Investor-Presentation-with-Appendix.pdf

Q2 2025 Results Presentation BMS-986517. ✦ Solid Tumors. CD40xFAP Bispecific. ✦ Solid Tumors. CEACAM5-TOPO1 ADC. ✦ Solid Tumors iza-bren. 1L Non-Small Cell Lung Cancer*.

6. ctv.veeva.com ctv.veeva.com/study/a-phase-1-2a-first-in-human-study-of-bms-986517-in-participants-with-advanced-solid-tumors

A Phase 1/2a, First-in-human, Study of BMS-986517 in ... A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid

7. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT07160725.html

A Phase 1/2a, First-in-human, Study of BMS-986517 in ... A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors.