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Bms-986442

BMS-986442, also known as AGEN1777, is an investigational drug being studied in clinical trials for the treatment of advanced solid tumors and non-small cell lung cancer. This article explores the ongoing research on BMS-986442 in combination with other therapies, providing insights into its potential benefits and the current state of clinical trials.

Table of Contents

What is BMS-986442?

BMS-986442, also known as AGEN1777, is a new drug being studied for the treatment of advanced solid tumors and non-small cell lung cancer (NSCLC)[1]. It is classified as a targeted antineoplastic antibody, which means it’s a type of medication designed to specifically target cancer cells while minimizing damage to healthy cells[1].

Medical Conditions Targeted

The primary focus of the clinical trials for BMS-986442 is on treating:

  • Advanced solid tumors: These are cancers that form solid masses in various parts of the body and have progressed to an advanced stage.
  • Non-small cell lung cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers[1].

How is it Administered?

BMS-986442 is administered as a solution for injection through intravenous (IV) infusion[1]. This means the medication is given directly into a vein, allowing it to enter the bloodstream quickly and reach cancer cells throughout the body.

Clinical Trial Details

The ongoing clinical trial for BMS-986442 is a Phase 1b/2 study, which aims to evaluate the drug’s safety, effectiveness, and optimal dosing[1]. The study is exploring BMS-986442 in combination with other treatments:

  1. BMS-986442 in combination with nivolumab (another immunotherapy drug)
  2. BMS-986442 in combination with nivolumab and chemotherapy

The main objectives of the trial are:

  • To assess the safety and tolerability of BMS-986442 in these combinations
  • To determine the Maximum Tolerated Dose (MTD), Maximum Administered Dose (MAD), and/or Recommended Phase 2 Dose (RP2D)[1]

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria. Some key eligibility requirements include:

  • Having measurable disease according to specific criteria (RECIST v1.1)[1]
  • Having an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which indicates the patient is relatively active and able to care for themselves[1]
  • Having a life expectancy of at least 3 months[1]

Some conditions that may exclude a patient from participating include:

  • Untreated symptomatic brain metastases or cancer that has spread to the protective layers of the brain and spinal cord[1]
  • Having another type of cancer that requires treatment or has been active in the past 2 years[1]
  • Having an active, known, or suspected autoimmune disease[1]

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks associated with participating in the BMS-986442 clinical trial:

Potential Benefits:

  • Access to a new, potentially effective treatment for advanced solid tumors or NSCLC
  • Close monitoring by healthcare professionals throughout the trial
  • Contributing to the advancement of cancer research

Potential Risks:

  • Possible side effects or adverse reactions to the medication
  • The treatment may not be effective for every participant
  • Time commitment required for study visits and procedures

The trial is closely monitoring for any adverse events (AEs), serious adverse events (SAEs), and other safety concerns[1]. Patients considering participation should discuss the potential risks and benefits with their healthcare provider.

Aspect Details
Drug Name BMS-986442 (AGEN1777)
Study Type Phase 1b/2 clinical trial
Target Conditions Advanced solid tumors and non-small cell lung cancer
Combination Therapy With nivolumab or nivolumab and chemotherapy
Main Objectives Safety, tolerability, MTD, MAD, and/or RP2D determination
Secondary Objectives Pharmacokinetics, immunogenicity, preliminary anti-tumor activity
Key Inclusion Criteria Measurable disease (RECIST v1.1), ECOG 0-1, life expectancy ≥3 months
Key Exclusion Criteria Untreated CNS metastases, concurrent malignancy, active autoimmune disease
Primary Endpoints Incidence of AEs, SAEs, DLTs, discontinuations, and death
Secondary Endpoints PK parameters, ADA incidence, anti-tumor efficacy (ORR, DOR, DCR, PFSR)

FAQ

  • What is BMS-986442 and what is it being studied for? BMS-986442, also known as AGEN1777, is an investigational drug being studied for the treatment of advanced solid tumors and non-small cell lung cancer. It is being tested in combination with nivolumab or with nivolumab and chemotherapy.
  • What is the main objective of the clinical trial involving BMS-986442? The main objective is to characterize the safety and tolerability of BMS-986442 in combination with other treatments, and to establish the maximum tolerated dose (MTD), maximum administered dose (MAD), and/or recommended phase 2 dose (RP2D).
  • Who is eligible to participate in this clinical trial? Eligible participants must have measurable disease according to RECIST v1.1 criteria, an ECOG Performance Status of 0 or 1, and a life expectancy of at least 3 months. Other specific inclusion and exclusion criteria apply.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include untreated symptomatic central nervous system metastases, concurrent malignancy requiring treatment, and active, known, or suspected autoimmune disease. However, there are other protocol-defined criteria that apply.
  • What are the primary endpoints of the study? The primary endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death. These are assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Ongoing Clinical Trials on Bms-986442

  • Study of BMS-986442 and Nivolumab, Alone or with Chemotherapy, for Patients with Advanced Solid Tumors and Non-Small Cell Lung Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Italy Poland Spain

Glossary

  • BMS-986442 (AGEN1777): An investigational drug being studied for the treatment of advanced solid tumors and non-small cell lung cancer.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers.
  • Nivolumab: An immunotherapy drug that works by helping the immune system recognize and attack cancer cells.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Maximum Administered Dose (MAD): The highest dose of a drug given in a clinical trial.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug recommended for further testing in phase 2 clinical trials.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • CTCAE v5.0: Common Terminology Criteria for Adverse Events version 5.0, a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.

References

  1. http://clinicaltrials.eu/trial/study-of-bms-986442-and-nivolumab-alone-or-with-chemotherapy-for-patients-with-advanced-solid-tumors-and-non-small-cell-lung-cancer/