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Bms-986449-03

BMS-986449-03 is an investigational drug currently being studied in clinical trials for patients with advanced solid tumors. This article provides an overview of the ongoing research, including the drug’s potential benefits, side effects, and eligibility criteria for participation in the trials. The information presented is based on a Phase 1/2 study combining BMS-986449 with nivolumab, aimed at evaluating its safety and effectiveness in treating various types of advanced cancer.

Table of Contents

What is BMS-986449-03?

BMS-986449-03 is a new drug being developed by Bristol-Myers Squibb International Corporation. It’s also known by its product name “HELIOS Degrader” or its sponsor product code “BMS-986449”[1]. This medication is currently in the experimental stage and is being tested in clinical trials to evaluate its effectiveness and safety in treating certain types of cancer.

The drug comes in the form of a hard capsule and is taken orally (by mouth)[1]. It’s important to note that as an investigational drug, it’s not yet approved for general use and is only available to patients participating in clinical trials.

What conditions does BMS-986449-03 target?

BMS-986449-03 is being studied for the treatment of advanced solid tumors. Specifically, it’s being investigated for:

  • Advanced, metastatic, or recurrent solid tumors: These are cancers that have spread from where they started to other parts of the body or have come back after initial treatment[1].
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is one of the most common forms of the disease[1].
  • Triple-negative breast cancer (TNBC): A particularly aggressive type of breast cancer that lacks three common receptors found in other types of breast cancer, making it harder to treat[1].

Study Details

The current study of BMS-986449-03 is a Phase 1/2 clinical trial[1]. This means it’s in the early stages of testing in humans. The study is designed to evaluate:

  1. BMS-986449-03 used alone (monotherapy)
  2. BMS-986449-03 used in combination with another drug called nivolumab

Nivolumab is an existing immunotherapy drug that helps the immune system fight cancer cells. By combining BMS-986449-03 with nivolumab, researchers hope to enhance the effectiveness of cancer treatment[1].

Who can participate in the study?

The study has specific criteria for who can participate. Eligible participants include:

  • Adults aged 18 years or older[1]
  • Patients with confirmed advanced, unresectable (cannot be removed by surgery), metastatic, or recurrent solid tumors[1]
  • Patients who have already tried existing therapies without success, or are not eligible for or cannot tolerate standard treatments[1]
  • Patients with measurable disease according to specific criteria (RECIST v 1.1)[1]
  • Patients who can provide a tumor biopsy (unless medically unable to do so)[1]

Who cannot participate in the study?

Certain conditions may prevent a person from participating in the study. These include:

  • Active, known, or suspected autoimmune diseases[1]
  • Conditions requiring systemic corticosteroid treatment within 14 days or other immunosuppressive medications within 30 days of starting the study[1]
  • Prior organ or tissue transplant[1]
  • History of severe side effects from previous immunotherapy treatments[1]
  • Any significant acute or chronic medical illness that could interfere with the study[1]
  • Untreated or symptomatic brain metastases or cancer that has spread to the protective layers of the brain (leptomeningeal metastases)[1]

What are the study objectives?

The main goals of this study are:

  1. Safety and tolerability: To understand how safe BMS-986449-03 is when used alone and in combination with nivolumab, and how well patients can tolerate the treatment[1].
  2. Pharmacokinetics: To study how the drug moves through the body, including how it’s absorbed, distributed, and eliminated. This helps researchers understand the best dosing strategies[1].

How is safety monitored?

The study closely monitors the safety of participants. This includes:

  • Tracking the occurrence of dose-limiting toxicities (side effects severe enough to prevent increasing the dose)
  • Monitoring for adverse events (AEs) and serious adverse events (SAEs)
  • Recording any side effects that lead to discontinuation of the treatment
  • Tracking any deaths that occur during the study[1]

All of these events are categorized using a standardized system called the NCI-CTCAE v5.0 (National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0)[1].

Data Sharing and Transparency

Bristol-Myers Squibb, the company developing BMS-986449-03, has committed to sharing data from this study. They will provide access to individual anonymized participant data to qualified researchers, subject to certain criteria. This approach promotes transparency and allows for further analysis that may benefit future patients and advance medical knowledge[1].

Aspect Details
Drug Name BMS-986449-03 (HELIOS Degrader)
Study Type Phase 1/2 clinical trial
Target Conditions Advanced solid tumors, including NSCLC and TNBC
Administration Oral capsule
Combination Therapy Tested alone and with nivolumab
Primary Objectives Safety, tolerability, and pharmacokinetics
Key Eligibility Criteria Age ≥18, advanced solid tumors, prior treatment failure
Main Exclusion Criteria Active autoimmune disease, recent immunosuppressive treatment, certain prior treatment toxicities
Effectiveness Measures Adverse events, pharmacokinetic parameters

FAQ

  • What is BMS-986449-03? BMS-986449-03 is an investigational drug being studied for the treatment of advanced solid tumors. It is administered orally in the form of a hard capsule and is being tested both alone and in combination with another drug called nivolumab.
  • What types of cancer is BMS-986449-03 being studied for? The clinical trial is focusing on patients with advanced, metastatic, or recurrent solid tumors. Specific cancer types mentioned in the study include non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
  • What are the main goals of the clinical trial? The primary objectives of the trial are to evaluate the safety and tolerability of BMS-986449-03 when used alone and in combination with nivolumab. The study also aims to understand how the drug behaves in the body (pharmacokinetics) in both scenarios.
  • Who is eligible to participate in the clinical trial? Eligible participants must be 18 years or older with confirmed advanced solid tumors. They should have already tried existing therapies or be ineligible for them. Participants must have measurable disease and be willing to undergo a tumor biopsy. However, there are specific exclusion criteria, such as having active autoimmune diseases or certain previous treatment-related side effects.
  • How is the effectiveness of BMS-986449-03 being measured? The trial measures the drug's effectiveness by monitoring side effects, including dose-limiting toxicities and adverse events. It also examines how the drug and its metabolites behave in the body by measuring various pharmacokinetic parameters in the blood.

Ongoing Clinical Trials on Bms-986449-03

  • Study of BMS-986449 and Nivolumab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Italy The Netherlands Spain

Glossary

  • Advanced solid tumors: Cancers that have spread from where they started to other parts of the body and are usually difficult to treat.
  • Metastatic: Cancer that has spread from its original location to other parts of the body.
  • Pharmacokinetic (PK) profile: The way a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • NSCLC: Non-small cell lung cancer, a type of lung cancer that is one of the most common forms of the disease.
  • TNBC: Triple-negative breast cancer, an aggressive type of breast cancer that lacks certain receptors, making it harder to treat with some common therapies.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Dose-limiting toxicities: Side effects of a drug that are severe enough to prevent increasing the dose or continuing treatment.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it is caused by the treatment.
  • CNS metastases: Cancer that has spread to the brain or spinal cord (central nervous system) from its original location in the body.
  • Nivolumab: A type of immunotherapy drug that helps the immune system fight cancer cells.

References

  1. http://clinicaltrials.eu/trial/study-of-bms-986449-and-nivolumab-for-patients-with-advanced-solid-tumors/