BMS-986506 for Kidney Cancer

Not yet recruiting at 8 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must not be taking: Colony-stimulating factors

Disqualifiers: Hypoxia, Oral medication intolerance, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986506, for advanced Clear Cell Renal Cell Carcinoma (ccRCC), a type of kidney cancer. The main goal is to determine the drug's safety for people with this cancer type. The study consists of different parts, each focusing on participants who have previously tried other treatments. Individuals who have undergone kidney cancer treatments such as immunotherapy and targeted therapy might be suitable candidates. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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 coordinators or your doctor.

Is there any evidence suggesting that BMS-986506 is likely to be safe for humans?

Research shows that BMS-986506 is being tested for safety and tolerability in individuals with advanced clear cell renal cell carcinoma (ccRCC). As this is the first human trial of BMS-986506, no prior safety information exists. Researchers aim to observe how participants respond to the treatment and identify potential side effects.

This study is in an early phase, focusing primarily on gathering initial safety data. Participants might experience side effects, though these are currently unknown. Monitoring safety will be crucial to ensure participants' well-being. ^{1 2 3 4 5}

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

Unlike the standard treatments for kidney cancer, which often involve surgery, immunotherapy, or targeted therapies like tyrosine kinase inhibitors, BMS-986506 is unique because it introduces a novel mechanism of action. Researchers are excited about this treatment because it targets specific pathways in cancer cells that current therapies do not, potentially offering a new approach to tackling the disease. By focusing on these unique pathways, BMS-986506 could provide an effective alternative for patients who do not respond well to existing treatments, offering hope for improved outcomes.

What evidence suggests that BMS-986506 might be an effective treatment for kidney cancer?

Research shows that BMS-986506 is a new treatment being tested for advanced clear cell renal cell carcinoma, a type of kidney cancer. This study marks the first time it has been tried in humans, so its effectiveness for this condition remains unknown. Participants will receive BMS-986506 in different study phases, such as Part 1A, Part 2A, or Part 2B. The main goal is to determine if people can take it safely without major side effects. Although data on its effectiveness is not yet available, researchers are hopeful because the treatment targets specific parts of cancer cells. This targeting could potentially slow down or stop cancer growth. ^{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 advanced Clear Cell Renal Cell Carcinoma (ccRCC), a type of kidney cancer. Specific eligibility criteria are not provided, but typically participants must have measurable disease and adequate organ function, and cannot be on conflicting medications or have certain health conditions.

Inclusion Criteria

My kidney cancer is confirmed to be advanced or has spread.

I have undergone at least two treatments including immunotherapy and targeted therapy.

I've been treated with both a PD-1/L1 inhibitor and a VEGF-TKI for my condition.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I can take pills without needing to alter them.

I haven't taken any colony-stimulating factors in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986506 to assess safety and tolerability

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-986506

Trial Overview The study is testing the safety and tolerability of a new medication called BMS-986506 when taken alone by patients with ccRCC. As it's a first-in-human study, this phase will likely focus on determining appropriate dosages.

How Is the Trial Designed?

Group I: BMS-986506: Part 2B Experimental Treatment 1 Intervention

Group II: BMS-986506: Part 2A Experimental Treatment 1 Intervention

Group III: BMS-986506: Part 1A 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/NCT07195682

A First-in-Human Study of BMS-986506 in Participants With ... The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.

2. withpower.com withpower.com/trial/phase-1-carcinoma-renal-cell-11-2025-c6d8c

BMS-986506 for Kidney Cancer · Info for Participants This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/35744396/bristol-myers-squibbs-new-study-on-bms-986506-a-potential-game-changer-in-renal-cell-carcinoma-treatment/

Bristol-Myers Squibb's New Study on BMS-986506 ' The study aims to evaluate the safety and tolerability of the drug BMS-986506 when administered alone to participants with advanced ccRCC, a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11670916/

Real-World Outcomes in Patients With Metastatic Renal ... This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients with I/P-risk mRCC.

5. zacks.com zacks.com/stock/news/2476705/exel-reports-superior-efficacy-data-from-kidney-cancer-study-cohort

EXEL Reports Superior Efficacy Data From Kidney Cancer ... Exelixis' zanzalintinib/Opdivo combo shows superior efficacy for treating kidney cancer in an expansion cohort of the phase Ib/II ...

6. ichgcp.net ichgcp.net/amp/clinical-trials-registry/554653-a-first-in-human-study-of-bms-986506-in-participants-with-advanced-clear-cell-renal-cell-carcinoma-ccrcc

Clinical Trial for Advanced Kidney Cancer Treatment with BMS ... Clinical trial investigating BMS-986506 for advanced clear cell renal cell carcinoma. Learn about eligibility, safety monitoring, and treatment approach for ...

7. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-a-first-in-human-study-of-bms-986506-in-participants-with-advanced-clear-cell-renal-cell-carcinoma--ccrcc-/555763336

Clinical Trial: A First-in-Human Study of BMS-986506 ... The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC. Study ...