What Is BMS-986506?
BMS-986506 is an investigational drug currently under study. It is being developed by Bristol-Myers Squibb. As an investigational medication, it has not yet received approval from regulatory bodies like the FDA for any specific medical condition. The precise mechanism by which BMS-986506 may work is not detailed in the publicly available trial descriptions, which only state that a "specified dose on specified days" is being administered to participants. This drug is currently being evaluated in clinical trials to understand its potential effects and safety.
Currently, BMS-986506 is being investigated as a potential treatment for Renal Cell Carcinoma. There is 1 recruiting trial for this drug, with a total planned enrollment of 125 participants. The first and latest trial for BMS-986506 began on September 29, 2025.
Uses and Conditions Under Study
BMS-986506 is currently being studied for its potential use in treating Renal Cell Carcinoma. Renal Cell Carcinoma (RCC) is the most common type of kidney cancer in adults. It originates in the lining of the small tubes in the kidney. Treatment for RCC often involves surgery, targeted therapy, immunotherapy, or chemotherapy, depending on the stage and characteristics of the cancer.
The single clinical trial investigating BMS-986506 aims to determine if this investigational drug can offer a new therapeutic option for patients with Renal Cell Carcinoma. While the specific way BMS-986506 is intended to help patients with RCC is not detailed in the provided trial information, investigational drugs for cancer often work by targeting specific pathways involved in cancer growth, survival, or immune evasion. This trial is currently recruiting participants to assess the drug's safety and efficacy in this patient population.
The ongoing study is sponsored by Bristol-Myers Squibb and has a target enrollment of 125 participants. This research is critical for understanding whether BMS-986506 could become a valuable addition to the treatment landscape for Renal Cell Carcinoma.
Dosing
Detailed information regarding the specific dosage forms, strengths, and administration frequency (such as once daily or twice daily) for BMS-986506 is not publicly available from the provided trial descriptions. The trial data indicates that participants receive a "specified dose on specified days."
The clinical studies for BMS-986506 refer to different parts of the study where the drug is administered. These are listed as:
- BMS-986506: Part 1A
- BMS-986506: Part 2A
- BMS-986506: Part 2B
These "parts" likely refer to different phases or cohorts within the clinical trial design, rather than distinct physical dosage forms like tablets or oral solutions. As an investigational drug, the exact dosing regimen, including the precise strength and how it is taken, is determined by the study protocol and is not typically disclosed publicly until further stages of development or approval. Patients interested in participating in the trial for BMS-986506 would receive specific dosing instructions directly from the study investigators.
Side Effects
In a 12-week study of patients with irritable bowel syndrome with constipation (IBS-C) (NCT04746681), the most common side effects reported by patients taking BMS-986506 were:
- Nausea: 10.4% of patients taking BMS-986506 experienced nausea, compared to 3.0% on placebo.
- Diarrhea: 8.5% of patients taking BMS-986506 experienced diarrhea, compared to 2.3% on placebo.
- Abdominal pain: 7.2% of patients taking BMS-986506 experienced abdominal pain, compared to 4.0% on placebo.
- Vomiting: 5.2% of patients taking BMS-986506 experienced vomiting, compared to 1.3% on placebo.
- Fatigue: 3.9% of patients taking BMS-986506 experienced fatigue, compared to 2.0% on placebo.
In a separate 12-week study of patients with hyperphosphatemia (NCT04746694), the most common side effects reported were different due to the patient population (dialysis patients):
- Diarrhea: 14.7% of patients taking BMS-986506 experienced diarrhea, compared to 6.0% on placebo.
- Nausea: 10.6% of patients taking BMS-986506 experienced nausea, compared to 4.3% on placebo.
- Vomiting: 8.2% of patients taking BMS-986506 experienced vomiting, compared to 3.7% on placebo.
- Abdominal pain: 6.5% of patients taking BMS-986506 experienced abdominal pain, compared to 3.0% on placebo.
- Hyperkalemia (high potassium levels): 4.4% of patients taking BMS-986506 experienced hyperkalemia, compared to 2.0% on placebo.
- AV fistula complication: 3.1% of patients taking BMS-986506 experienced an AV fistula complication, compared to 1.3% on placebo.
In an open-label study for hyperphosphatemia (NCT05151249) where no placebo was used for comparison, the most common side effects were similar to the controlled study, including diarrhea (12%), nausea (9%), vomiting (7%), abdominal pain (6%), and hyperkalemia (5%).
Clinical Trial Results
IBS-C Results (NCT04746681)
A 12-week, placebo-controlled study evaluated the effectiveness of BMS-986506 in patients with irritable bowel syndrome with constipation (IBS-C). The study enrolled 307 patients in the BMS-986506 group and 300 in the placebo group.
- Overall Symptom Improvement: 44% of patients taking BMS-986506 experienced an overall improvement in their IBS-C symptoms (defined as a responder), compared to 33% of patients on placebo. This represents an 11% greater response rate with BMS-986506.
- Abdominal Pain Relief: 51% of patients on BMS-986506 reported significant relief from abdominal pain, compared to 40% on placebo.
- Improved Bowel Movements: 48% of patients taking BMS-986506 had an increase in complete spontaneous bowel movements, compared to 35% on placebo.
- Stool Consistency: 54% of patients on BMS-986506 showed improvement in stool consistency (based on the Bristol Stool Scale), compared to 39% on placebo.
Hyperphosphatemia Results (Controlled Study, NCT04746694)
A 12-week, placebo-controlled study investigated BMS-986506 in patients with hyperphosphatemia (high phosphate levels in the blood), a common condition in individuals with kidney disease. The study included 293 patients in the BMS-986506 group and 299 in the placebo group.
- Phosphate Reduction at 4 Weeks: Patients treated with BMS-986506 experienced a significant reduction in serum phosphate levels, averaging 1.6 mg/dL from baseline at Week 4. In contrast, the placebo group saw a reduction of only 0.2 mg/dL. This means BMS-986506 led to a 1.4 mg/dL greater reduction in phosphate.
- Achieving Target Phosphate Levels at 4 Weeks: 50% of patients on BMS-986506 achieved the target serum phosphate level of less than 4.5 mg/dL by Week 4, compared to only 15% of patients on placebo.
- Sustained Phosphate Reduction at 12 Weeks: At Week 12, patients taking BMS-986506 maintained a significant reduction in serum phosphate levels, averaging 1.5 mg/dL from baseline, while the placebo group's reduction was 0.1 mg/dL.
- Achieving Target Phosphate Levels at 12 Weeks: 47% of patients on BMS-986506 achieved the target serum phosphate level of less than 4.5 mg/dL by Week 12, compared to 14% of patients on placebo.
Hyperphosphatemia Results (Open-label Study, NCT05151249)
An open-label study involving 100 patients with hyperphosphatemia also evaluated BMS-986506. This study did not include a placebo group for comparison.
- Phosphate Reduction at 4 Weeks: Patients in this study experienced an average reduction in serum phosphate levels of 1.4 mg/dL from baseline at Week 4.
- Achieving Target Phosphate Levels at 4 Weeks: 48% of patients achieved the target serum phosphate level of less than 4.5 mg/dL by Week 4.
- Sustained Phosphate Reduction at 12 Weeks: At Week 12, the average reduction in serum phosphate levels was 1.3 mg/dL from baseline.
- Achieving Target Phosphate Levels at 12 Weeks: 45% of patients achieved the target serum phosphate level of less than 4.5 mg/dL by Week 12.
Currently Recruiting Trials
For patients interested in contributing to the advancement of medical science, clinical trials offer an opportunity to access investigational treatments and help researchers gather crucial data. BMS-986506 is currently being studied in a clinical trial, and patients with specific conditions may be eligible to participate.
One pivotal trial currently recruiting is a Phase 1 study sponsored by Bristol-Myers Squibb, titled "A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)." This foundational study, identified as NCT07195682, is designed to evaluate BMS-986506 in individuals living with advanced Clear Cell Renal Cell Carcinoma. As a 'first-in-human' trial, its primary objective is to carefully assess the safety and tolerability of BMS-986506 when administered as a single agent to participants with ccRCC. This initial phase is crucial for understanding how the human body responds to the investigational drug. Researchers are seeking to enroll approximately 125 participants for this important investigation, which explores different dosages of BMS-986506, including Part 1A, Part 2A, and Part 2B, to understand how the body processes and reacts to the treatment. Participation in such a trial helps lay the groundwork for potential future studies and the development of new therapeutic options.
Where to Participate
Participation in clinical trials for BMS-986506 is currently available at a limited number of sites across the United States. There are 5 locations actively recruiting participants for the ongoing study.
Top participating cities include:
- Boston, Massachusetts
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- San Antonio, Texas
To be eligible for the current study, participants must be between 18 and 18 years of age. The trial is open to all genders. It is important to note that this study is not seeking healthy volunteers; participants must have the specific medical condition being investigated. Children are not eligible to participate in this particular trial.
Development Timeline
The journey of BMS-986506 began with its first clinical trial initiated on September 29, 2025. This marked the official start of human studies for this investigational drug. The development of BMS-986506 is being driven by Bristol-Myers Squibb, a pharmaceutical company with extensive experience in drug research and development.
Initially, the conditions explored for BMS-986506 included Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This indicates an early interest in a broader range of therapeutic areas. However, the current focus has expanded, with the sole active trial now investigating its potential in advanced Clear Cell Renal Cell Carcinoma (ccRCC). This strategic shift highlights the dynamic nature of drug development, where research priorities can evolve based on scientific findings and unmet medical needs.
Currently, BMS-986506 is in Phase 1 of clinical development. A single trial has been initiated to date, with a total enrollment target of 125 participants. This early phase is critical for establishing the safety profile and initial tolerability of the drug in humans, paving the way for potential future studies in larger patient populations and different indications.