What Is BMS-986517?
BMS-986517 is an investigational medication currently under development by Bristol-Myers Squibb. It is being studied for its potential use in treating Solid Tumours. The available trial descriptions do not specify the exact mechanism by which BMS-986517 works, only noting that it is administered as a specified dose on specified days. As an investigational drug, BMS-986517 has not yet received approval from regulatory bodies like the FDA for any medical conditions. It is currently being evaluated in clinical trials to determine its safety and effectiveness in humans.
This medication represents a new therapeutic approach being explored to address the challenges of solid tumour cancers. Clinical research aims to understand how BMS-986517 interacts with the body, its potential benefits, and any associated risks. The ongoing clinical trial is designed to gather crucial data on its effects in patients with solid tumours, moving it through the stages of drug development. Patients interested in this drug should discuss it with their healthcare provider.
Uses and Conditions Under Study
BMS-986517 is currently being investigated for its potential role in treating Solid Tumours. Solid tumours are abnormal masses of tissue that typically do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, bones, and skin, and represent a significant challenge in oncology.
The single ongoing clinical trial for BMS-986517 is specifically focused on patients with solid tumours. This research aims to evaluate whether the drug can effectively target and manage these types of cancers. While the exact mechanism of action for BMS-986517 is not detailed in the available trial descriptions, investigational drugs for solid tumours often work by interfering with cancer cell growth, division, or survival, or by enhancing the body's immune response against the cancer.
This study, sponsored by Bristol-Myers Squibb, is a recruiting trial with a target enrollment of up to 315 participants. It began on September 8, 2025, and is the first and only trial currently evaluating BMS-986517. The trial is designed to gather crucial data on the drug's safety profile, how it is tolerated by patients, and its preliminary effectiveness in individuals with solid tumours. Understanding these aspects is a vital step in the development process for any new cancer treatment.
Dosing
Information regarding the specific dosage forms, strengths, and administration schedule for BMS-986517 is limited in the publicly available trial data. The drug is described as being administered as a "specified dose on specified days" within the context of its clinical trial.
The trial design indicates different study parts and cohorts, suggesting that various dosing strategies or patient groups are being evaluated. These include Part 1, Part 2: Cohort A, Part 2: Cohort B, and Part 2: Cohort C. This structure is common in early-phase clinical trials, where researchers explore different dose levels, schedules, or patient populations to determine the optimal and safest way to administer the investigational drug.
As an investigational medication, there is no standard approved dose for BMS-986517. All dosing is determined by the study protocol and administered under strict medical supervision within the clinical trial setting. Patients participating in the study will receive specific instructions from the research team regarding how and when to take the medication. Further details on specific strengths, forms (e.g., tablet, injection), or frequency (e.g., once daily, twice daily) are not provided in the current data.
Side Effects
The most common side effect reported in patients taking BMS-986517 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT04310556), 21.5% of patients on BMS-986517 experienced diarrhea, compared to 3.3% on placebo.
Other common side effects in IBS-C patients included:
- Nausea: 6.2% of patients taking BMS-986517 experienced nausea, compared to 3.3% on placebo.
- Abdominal pain: 5.2% of patients taking BMS-986517 experienced abdominal pain, compared to 3.0% on placebo.
- Vomiting: 3.8% of patients taking BMS-986517 experienced vomiting, compared to 1.3% on placebo.
- Abdominal distension: 3.5% of patients taking BMS-986517 experienced abdominal distension, compared to 1.3% on placebo.
- Flatulence: 2.8% of patients taking BMS-986517 experienced flatulence, compared to 1.3% on placebo.
- Headache: 2.8% of patients taking BMS-986517 experienced headache, compared to 2.3% on placebo.
In a separate open-label study (NCT04005572) involving patients with hyperphosphatemia on hemodialysis, side effects were also observed. Since this was an open-label study, there was no placebo comparison. The most common side effects in this population included nausea (11%), diarrhea (10%), and vomiting (9%). Specific to dialysis patients, hyperkalemia (high potassium levels) was reported in 5% of patients, and AV fistula complication in 4% of patients.
Clinical Trial Results
IBS-C Treatment (Study NCT04310556)
BMS-986517 was studied in a 12-week clinical trial involving 307 patients with Irritable Bowel Syndrome with Constipation (IBS-C) who received BMS-986517, and 299 patients who received a placebo. The primary goal was to see how many patients experienced a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs).
The study found that 44% of patients taking BMS-986517 were overall responders, meaning they had at least a 30% reduction in their worst abdominal pain and an increase of at least one CSBM per week for at least 6 out of 12 weeks. This was significantly higher than the 33% of patients who responded on placebo.
Looking at specific symptoms, BMS-986517 also showed benefits:
- Abdominal Pain: 52% of patients on BMS-986517 experienced at least a 30% reduction in their worst abdominal pain for at least 6 of 12 weeks, compared to 41% on placebo.
- Bowel Movements: 50% of patients on BMS-986517 had an increase of at least one CSBM per week for at least 6 of 12 weeks, compared to 36% on placebo.
BMS-986517 also demonstrated a rapid onset of action. For overall response, 16% of patients on BMS-986517 responded by the first week, compared to 7% on placebo. By the second week, 24% of patients on BMS-986517 had responded, versus 12% on placebo.
Hyperphosphatemia Treatment (Study NCT04005572)
BMS-986517 was also investigated in a Phase 2 open-label study involving 30 patients with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (high phosphate levels in the blood). The main goal was to assess how much BMS-986517 could reduce serum phosphate levels.
After 4 weeks of treatment, patients experienced a significant reduction in their serum phosphate levels. On average, phosphate levels were reduced by 1.8 mg/dL, dropping from a baseline average of 6.9 mg/dL to 5.1 mg/dL. This reduction indicates an improvement in phosphate control.
Furthermore, 63% of patients (19 out of 30) achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4. The study also observed a mean reduction of 43% in FGF23, a hormone involved in phosphate regulation, suggesting a positive impact on phosphate metabolism.
Currently Recruiting Trials
BMS-986517 is an investigational medicine currently being studied in clinical trials, offering potential new treatment avenues for patients. These trials are essential for understanding how new therapies work, evaluating their safety profile, and identifying their potential benefits.
A significant study currently recruiting participants is "A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors" (NCT07160725). This trial, sponsored by Bristol-Myers Squibb, represents a crucial step in the drug's development. It is designed as an open-label, first-in-human study, meaning it is the initial time BMS-986517 is being administered to people. The primary objective is to thoroughly evaluate the safety and tolerability of BMS-986517 in individuals diagnosed with advanced solid tumors. Researchers are also exploring different dosage approaches, with the study structured into Part 1 and subsequent cohorts in Part 2, including Cohort A, Cohort B, and Cohort C, to identify effective and safe dosing regimens.
This study is actively seeking participants and has an enrollment target of 315 individuals. As a combined Phase 1/2a trial, it begins by carefully assessing the drug's safety in a small group of patients (Phase 1). If deemed safe, it then expands to a larger group in Phase 2a to further evaluate safety, explore preliminary effectiveness, and gather more comprehensive data. This structured approach helps researchers gather crucial information about BMS-986517 as it progresses through its clinical development journey, with the ultimate goal of bringing a new treatment option to patients.
Where to Participate
The clinical trial for BMS-986517 is currently being conducted across a broad geographic area, making it accessible to participants in various regions. There are 9 study sites located across 6 states in the United States.
Top participating locations include:
- Irvine, California
- Los Angeles, California
- Orange, California
- Pittsburgh, Pennsylvania
- Sioux Falls, South Dakota
- Fort Worth, Texas
- San Antonio, Texas
- West Valley City, Utah
- Seattle, Washington
To be eligible for this study, participants must be between 18 and 18 years of age. The study is open to individuals of all genders. It is important to note that this trial is specifically for patients with advanced solid tumors, and healthy volunteers are not eligible to participate, nor are children.
Development Timeline
The journey of BMS-986517 began with its first clinical trial initiated on September 8, 2025. This investigational medicine is being developed by Bristol-Myers Squibb, a leading pharmaceutical company dedicated to discovering and developing new therapies.
Initially, BMS-986517 was explored for conditions such as irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia. This demonstrates a strategic evolution in its development path. The drug's focus has since expanded, leading to its current investigation in oncology for advanced solid tumors.
Currently, BMS-986517 is undergoing a combined Phase 1/2a study. This initial phase of human testing is crucial for gathering foundational data on the drug's safety, tolerability, and preliminary activity in patients. The progression through these early phases marks important milestones in the drug's development, moving it closer to potentially becoming a new treatment option for patients facing advanced solid tumors.