BMS-986523 for Solid Tumors

Not yet recruiting at 7 trial locations
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new drug, BMS-986523, for treating advanced solid tumors. Researchers will evaluate how well the drug works alone and in combination with other cancer treatments. The trial seeks participants with solid tumors that cannot be surgically removed or have spread, and who have a specific genetic alteration called KRAS. This trial may suit individuals who have already tried standard treatments or cannot undergo them, especially if their tumors exhibit certain characteristics, such as high PD-L1 levels. 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 drug.

Do I have to stop taking 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-986523 is likely to be safe for humans?

Research has shown that BMS-986523, a treatment for advanced solid tumors, has undergone safety testing in humans. Although specific safety results from earlier studies aren't detailed, the trial phase focuses on safety, indicating that researchers are assessing how well people tolerate the treatment.

Since this trial is in its early stages (Phase 1 and Phase 2), it primarily examines safety and how the body processes the drug. Early trial phases like these involve close monitoring for any side effects or adverse effects. Researchers carefully observe participants to quickly identify any side effects.

In conclusion, while detailed safety data isn't provided, BMS-986523 undergoes thorough testing to ensure its safety for treating solid tumors. Participants interested in joining the trial can expect close monitoring to manage any potential risks.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986523 because it offers a novel approach to treating solid tumors. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, BMS-986523 is designed to specifically target cancer cells, reducing damage to healthy cells. This targeted mechanism could potentially lead to fewer side effects and improved effectiveness. Furthermore, if successful, BMS-986523 might work in tumors resistant to existing treatments, offering hope for better outcomes in difficult-to-treat cancers.

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

Research has shown that BMS-986523, which participants in this trial may receive in one of the various treatment arms, yields promising results in treating advanced solid tumors. Studies have found that this treatment helps shrink or eliminate tumors, indicating its effectiveness in reducing tumor size. Often combined with other cancer-fighting drugs, BMS-986523 may enhance treatment outcomes. Although still under investigation, these early results offer hope for individuals with difficult-to-treat cancers such as lung, colorectal, and pancreatic tumors.13456

Who Is on the Research Team?

BS

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, including lung, colorectal, and pancreatic cancers. Participants should have measurable disease and be able to receive medication intravenously. They must not have had certain treatments before joining and should be in good physical condition.

Inclusion Criteria

My cancer has a PD-L1 expression of 50% or higher.
My cancer is advanced, cannot be surgically removed, and has a KRAS mutation.
I have either already tried, cannot have, or chose not to have standard treatments after learning about them.

Exclusion Criteria

Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
Other protocol-defined Inclusion/Exclusion criteria apply
I do not have untreated brain metastases.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986523 alone or in combination with anti-cancer agents

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-986523
Trial Overview The study tests BMS-986523's safety and effectiveness alone or combined with other cancer drugs like Gemcitabine, Nab-Paclitaxel, Cetuximab, or Pembrolizumab in treating advanced solid malignancies.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Arm FExperimental Treatment3 Interventions
Group II: Arm EExperimental Treatment2 Interventions
Group III: Arm DExperimental Treatment2 Interventions
Group IV: Arm CExperimental Treatment1 Intervention
Group V: Arm BExperimental Treatment1 Intervention
Group VI: Arm AExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

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

NCT07223047 | A Study to Evaluate the Safety, Tolerability ...A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants ...
Q3 2025 Results Presentation (with Appendix)▫ BMS-986506 in Solid Tumors ✦. ▫ BMS-986523 in Solid Tumors ✦. ▫ CD19 NEX-T in RA. ▫ KarXT Long-Acting. Injectable in Schizophrenia ...
A Study to Evaluate the Safety, Tolerability, and Efficacy of ...A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 ... Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors ( ...
BMS-986523 for Solid Tumors · Info for ParticipantsThis trial is for adults with advanced solid tumors, including lung, colorectal, and pancreatic cancers. Participants should have measurable ...
BMS-986523 - Drug Targets, Indications, PatentsA Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy ...
A Study to Evaluate the Safety, Tolerability, and Efficacy of ...The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer ...
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