In short
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.
At a glance
- 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
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". 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). 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.
- Non-small cell lung cancer (NSCLC): A type of lung cancer that is one of the most common forms of the disease.
- 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.
Study Details
The current study of BMS-986449-03 is a Phase 1/2 clinical trial. This means it's in the early stages of testing in humans. The study is designed to evaluate:
- BMS-986449-03 used alone (monotherapy)
- 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.
Who can participate in the study?
The study has specific criteria for who can participate. Eligible participants include:
- Adults aged 18 years or older
- Patients with confirmed advanced, unresectable (cannot be removed by surgery), metastatic, or recurrent solid tumors
- Patients who have already tried existing therapies without success, or are not eligible for or cannot tolerate standard treatments
- Patients with measurable disease according to specific criteria (RECIST v 1.1)
- Patients who can provide a tumor biopsy (unless medically unable to do so)
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
- Conditions requiring systemic corticosteroid treatment within 14 days or other immunosuppressive medications within 30 days of starting the study
- Prior organ or tissue transplant
- History of severe side effects from previous immunotherapy treatments
- Any significant acute or chronic medical illness that could interfere with the study
- Untreated or symptomatic brain metastases or cancer that has spread to the protective layers of the brain (leptomeningeal metastases)
What are the study objectives?
The main goals of this study are:
- 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.
- 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.
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
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).
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.