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BMS-986365

BMS-986365 (also known as CC-94676) is an investigational drug currently being studied in various clinical trials to evaluate its safety, efficacy, and pharmacological properties. The clinical trials range from early Phase 1 studies in healthy volunteers to advanced Phase 3 trials in patients with metastatic castration-resistant prostate cancer (mCRPC). These studies aim to understand how the drug works in the body, how it’s processed, and most importantly, how it compares to existing treatments for prostate cancer. The research is designed to provide crucial information about proper dosing, potential side effects, and the overall benefit-risk profile of BMS-986365 before it can be considered for wider use in patient care.

Table of Contents

What is BMS-986365?

BMS-986365 (also known as CC-94676) is an investigational medication currently being studied in clinical trials. It is not yet approved by regulatory agencies for widespread use and is still in the research and development phase[1]. The drug is being developed by Bristol Myers Squibb, as indicated by the “BMS” prefix in its name.

At this stage, researchers are conducting various studies to understand how the drug works in the body, including how it’s absorbed, distributed, metabolized, and eliminated. These studies are essential steps in determining whether BMS-986365 could be safe and effective for treating specific conditions[2].

What Conditions Does BMS-986365 Treat?

Based on the clinical trial information available, BMS-986365 is primarily being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC)[3]. This is an advanced form of prostate cancer that has spread beyond the prostate to other parts of the body (metastasized) and continues to progress despite treatments that lower testosterone levels (castration therapy).

Metastatic castration-resistant prostate cancer represents one of the most challenging stages of prostate cancer to treat, as the cancer has developed resistance to standard hormone therapy approaches. New treatment options are needed for patients at this stage, which is why drugs like BMS-986365 are being investigated[3].

Current Clinical Research

BMS-986365 is currently being studied in several clinical trials that are designed to evaluate different aspects of the drug’s properties and effectiveness:

Phase 1 Studies

Two Phase 1 studies are focusing on understanding how BMS-986365 works in the body of healthy volunteers:

  • A study evaluating the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of BMS-986365 at different doses. This study also examines how food and acid-reducing medications like rabeprazole (a proton pump inhibitor) might affect how the drug is absorbed[1].
  • A study looking at how BMS-986365 is metabolized and excreted from the body, as well as its absolute bioavailability (the percentage of the drug that enters circulation when introduced into the body). This research uses radioactively labeled versions of the drug ([14C] BMS-986365) to track its movement through the body[2].

Phase 3 Study

A more advanced Phase 3 clinical trial called “rechARge” is comparing BMS-986365 to current standard treatments for metastatic castration-resistant prostate cancer. This study is designed to determine if BMS-986365 is more effective than existing therapies[3].

In this trial, BMS-986365 is being compared to the investigator’s choice of:

  • Docetaxel plus Prednisone/Prednisolone (a chemotherapy approach), or
  • Second Androgen Receptor Pathway Inhibitors (ARPIs) such as:
    • Abiraterone plus Prednisone/Prednisolone, or
    • Enzalutamide

The primary goal of this Phase 3 trial is to measure radiographic progression-free survival (rPFS), which is the length of time during and after treatment that the cancer does not grow or spread, as determined by imaging tests reviewed by independent experts[3].

Safety Monitoring and Side Effects

As with all investigational drugs, researchers are carefully monitoring the safety of BMS-986365. The clinical trials are tracking several safety measures, including[1][2][3]:

  • Adverse events (side effects)
  • Serious adverse events
  • Changes in laboratory tests (blood tests)
  • Electrocardiogram (ECG) findings to monitor heart function
  • Vital signs
  • Physical examination findings

Since BMS-986365 is still in clinical trials, a complete profile of potential side effects is not yet established. The ongoing studies will help identify what side effects might occur and how common they are[3].

Drug Interactions and Food Effects

Part of the research on BMS-986365 is examining how other factors might affect how the drug works in the body:

  • Food effects: Researchers are studying whether taking BMS-986365 with food (fed state) versus without food (fasted state) affects how well the drug is absorbed[1].
  • Acid-reducing medications: One study is specifically looking at how rabeprazole, a proton pump inhibitor that reduces stomach acid production, might interact with BMS-986365. This is important because many patients with cancer take medications to reduce stomach acid to manage symptoms or side effects of treatment[1].

Understanding these interactions will help determine the best way to administer BMS-986365 if it eventually receives approval for clinical use.

How BMS-986365 is Administered

The clinical trials indicate that BMS-986365 is being tested in different formulations, including tablets and capsules[1]. Part of the research is comparing how these different formulations are absorbed and utilized by the body (bioavailability).

The exact dosing schedule is still being determined through the clinical trials, with different dose levels being tested to find the optimal balance between effectiveness and safety. In the Phase 3 trial, two different dose levels of BMS-986365 are initially being evaluated in Part 1, with the more promising dose selected for further testing in Part 2[3].

Comparison to Other Treatments

The Phase 3 clinical trial is directly comparing BMS-986365 to current standard treatments for metastatic castration-resistant prostate cancer[3]. These standard treatments include:

  1. Docetaxel with Prednisone/Prednisolone: Docetaxel is a chemotherapy drug that works by interfering with cell division, while prednisone helps reduce inflammation and some cancer-related symptoms.
  2. Androgen Receptor Pathway Inhibitors (ARPIs):
    • Enzalutamide: This medication blocks the effect of testosterone and other male hormones on prostate cancer cells.
    • Abiraterone with Prednisone/Prednisolone: Abiraterone works by reducing androgen production throughout the body, not just in the testicles.

The clinical trial is measuring not only how BMS-986365 affects cancer progression compared to these treatments but also how it impacts patients’ quality of life and pain levels. This is being assessed using standardized questionnaires such as the Functional Assessment of Cancer Therapy – Prostate Cancer (FACT-P) and the Brief Pain Inventory – Short Form (BPI-SF)[3].

If BMS-986365 proves to be more effective than current treatments with a manageable safety profile, it could potentially become an important new option for patients with metastatic castration-resistant prostate cancer.

Trial Phase Trial Description Population Key Objectives Measurements
Phase 1 Two-part, open-label single ascending dose study (NCT06417229) Healthy adult males Evaluate safety, tolerability, pharmacokinetics, food effects, and relative bioavailability of different formulations Drug concentration, safety parameters, effects of food and acid-reducing medications
Phase 1 Open-label, two-part study of metabolism and absolute bioavailability (NCT06433505) Healthy adult males Assess pharmacokinetics, metabolite profile, routes of elimination, and absolute bioavailability Drug concentration, half-life, clearance, bioavailability, safety parameters
Phase 3 Randomized, open-label, adaptive study “rechARge” (NCT06764485) Patients with metastatic castration-resistant prostate cancer Compare efficacy and safety of BMS-986365 vs. standard therapies (docetaxel or second-line hormone therapy) Radiographic progression-free survival, overall survival, quality of life, pain progression, PSA response

FAQ

  • What is BMS-986365 and what is it being studied for? BMS-986365 (also known as CC-94676) is an investigational drug currently being evaluated in clinical trials. It's being studied primarily for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in a Phase 3 trial, where it's being compared to standard therapies like docetaxel and androgen receptor pathway inhibitors. It's also undergoing Phase 1 trials in healthy volunteers to understand how the drug behaves in the human body.
  • What types of clinical trials are being conducted with BMS-986365? There are several types of trials currently underway for BMS-986365. These include Phase 1 studies in healthy volunteers to assess safety, drug levels, metabolism, and how food affects absorption. There's also an advanced Phase 3 trial (called 'rechARge') comparing BMS-986365 to existing treatments for metastatic castration-resistant prostate cancer to determine if it's more effective and safer than current options.
  • How is BMS-986365 being compared to existing prostate cancer treatments? In the Phase 3 'rechARge' trial, BMS-986365 is being compared to investigator's choice of therapy, which includes either docetaxel plus prednisone/prednisolone (chemotherapy) or second-line hormone therapies like enzalutamide or abiraterone plus prednisone/prednisolone. The main outcome being measured is radiographic progression-free survival (rPFS), which shows how long patients live without their cancer growing or spreading as seen on imaging tests. Other important outcomes include overall survival and quality of life measures.
  • What information are researchers trying to learn from the Phase 1 studies of BMS-986365? The Phase 1 studies are designed to understand fundamental aspects of how BMS-986365 works in the body. Researchers are investigating the drug's pharmacokinetics (how the body processes the drug), including how it's absorbed, distributed, metabolized, and eliminated. They're also studying different formulations (tablets vs. capsules), the effects of food on drug absorption, and the impact of acid-reducing medications like rabeprazole. These studies help determine the optimal dosing strategy and identify any initial safety concerns before testing in patients with cancer.
  • What are the main outcomes being measured in the clinical trials of BMS-986365? In the Phase 1 trials, researchers are primarily measuring pharmacokinetic parameters such as maximum drug concentration in the blood, how long the drug stays in the body, and how it's cleared. They're also closely monitoring for any side effects or safety concerns. In the Phase 3 prostate cancer trial, the main outcome is radiographic progression-free survival (how long patients live without their cancer growing on scans). Secondary outcomes include overall survival, response rates, pain progression, quality of life measures, and safety assessments.

Ongoing Clinical Trials on BMS-986365

  • Study Comparing BMS-986365 with Other Treatments for Patients with Metastatic Castration-resistant Prostate Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Czechia Denmark France Germany Ireland +6

  • BMS-986365 in Metastatic Castration-Sensitive Prostate Cancer in Patients with Suboptimal PSA Response After ADT and ARPI

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect. Absolute bioavailability compares the drug given orally versus intravenously.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Metastatic Castration-resistant Prostate Cancer (mCRPC): An advanced form of prostate cancer that has spread beyond the prostate (metastatic) and continues to grow despite treatments that reduce testosterone levels (castration-resistant).
  • Radiographic Progression-Free Survival (rPFS): The length of time during and after treatment that a patient lives with cancer without it growing or spreading, as determined by imaging tests.
  • Androgen Receptor Pathway Inhibitor (ARPI): A type of medication that blocks the effects of male hormones (androgens) on prostate cancer cells, which can help slow cancer growth.
  • Mass Balance: A study that tracks where a drug goes in the body and how it's eliminated by using a radioactive label (like 14C) to follow the drug and its metabolites.
  • Maximum Observed Concentration (Cmax): The highest concentration of a drug in the blood after administration, which helps determine how much of the drug reaches the bloodstream.
  • Area Under the Curve (AUC): A measurement of the total exposure to a drug over time, which helps determine the appropriate dosage.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a drug, whether or not considered related to the drug.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes a persistent or significant disability, or other important medical events.
  • Proton Pump Inhibitor: A type of medication (like rabeprazole) that reduces stomach acid production, which can potentially affect how some drugs are absorbed in the body.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors – a standardized way to measure if tumors in cancer patients respond to treatment, shrink, or grow.
  • PCWG3: Prostate Cancer Clinical Trials Working Group 3 – guidelines for designing and conducting clinical trials in prostate cancer, including how to assess bone metastases.
  • Overall Survival (OS): The length of time from the start of treatment until death from any cause, a key measure of treatment effectiveness in cancer trials.
  • FACT-P: Functional Assessment of Cancer Therapy – Prostate, a questionnaire that measures quality of life in prostate cancer patients.
  • Half-life (T-HALF): The time it takes for the concentration of a drug in the body to be reduced by half, which helps determine how often a drug needs to be taken.
  • Prostate-Specific Antigen (PSA): A protein produced by the prostate gland; elevated levels in the blood may indicate prostate cancer or other prostate conditions. PSA response rate refers to the percentage of patients whose PSA levels decrease by a certain amount after treatment.

References

  1. https://clinicaltrials.gov/study/NCT06417229
  2. https://clinicaltrials.gov/study/NCT06433505
  3. https://clinicaltrials.gov/study/NCT06764485