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Bms-986340

BMS-986340 is an investigational drug currently being studied in clinical trials for the treatment of various advanced solid tumors. This article provides an overview of the ongoing research, focusing on its potential as a monotherapy and in combination with other drugs like nivolumab and docetaxel. The study aims to assess the safety, tolerability, and recommended dosage of BMS-986340 in patients with different types of cancer, including lung, gastric, colorectal, and head and neck cancers, among others.

Table of Contents

What is BMS-986340?

BMS-986340 is a new drug that is currently being investigated for the treatment of various advanced solid tumors[1]. It is considered a “first-in-human” study, which means that this is the first time the drug is being tested in people. The main purpose of the ongoing clinical trial is to assess how safe and tolerable BMS-986340 is, and to determine the recommended dose for future treatments[1].

What conditions does BMS-986340 treat?

BMS-986340 is being studied for the treatment of several types of advanced solid tumors. These include:

  • Gastric and gastroesophageal junction adenocarcinoma: Cancer of the stomach or the area where the stomach meets the esophagus
  • Microsatellite stable colorectal cancer: A type of colon or rectal cancer that doesn’t have certain genetic changes
  • Non-small-cell lung cancer: The most common type of lung cancer
  • Squamous cell carcinoma of head and neck: Cancer that begins in the flat cells lining the inside of the mouth, nose, and throat
  • Renal cell carcinoma: The most common type of kidney cancer
  • Urothelial carcinoma: Cancer that typically occurs in the urinary system
  • Pancreatic adenocarcinoma: The most common type of pancreatic cancer
  • Ovarian neoplasms: Various types of tumors that can occur in the ovaries
  • Triple negative breast neoplasms: A type of breast cancer that doesn’t have certain receptors commonly found in other breast cancers
  • Cervical cancer: Cancer that occurs in the cells of the cervix
  • Melanoma: A serious type of skin cancer

This wide range of cancer types suggests that BMS-986340 may have broad potential in treating various solid tumors[1].

How is BMS-986340 being studied?

The clinical trial for BMS-986340 is divided into several parts:

  1. Part 1A and 2A: These parts focus on BMS-986340 as a single therapy (monotherapy). The goal is to find the right dose and see how well it works on its own[1].
  2. Part 1B and 2B: In these parts, BMS-986340 is combined with another drug called nivolumab (also known as BMS-936558-01). This combination is being tested to see if it works better than BMS-986340 alone[1].
  3. Part 1C: This part examines BMS-986340 in combination with a chemotherapy drug called docetaxel[1].

Each part of the study has a specific purpose, either to determine the right dose (dose escalation) or to further test the effectiveness of the drug at the chosen dose (dose expansion)[1].

Safety and Efficacy Measures

The study is closely monitoring several aspects of BMS-986340’s performance:

  • Safety: Researchers are tracking any side effects, including how often they occur and how severe they are. They’re particularly interested in serious side effects and any that might limit the dose that can be given[1].
  • Effectiveness: The study is measuring how well the drug works against tumors. This includes looking at:
    • Objective response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment
    • Disease control rate (DCR): The percentage of patients whose cancer shrinks or stays the same size
    • Duration of response (DOR): How long the cancer remains controlled after treatment
    • Progression-free survival rate (PFSR): The percentage of patients whose cancer doesn’t grow or spread after a certain time
    These measures will be assessed at 6 months and 12 months after treatment starts[1].

Combination Therapy with BMS-986340

BMS-986340 is being studied both alone and in combination with other drugs:

  • Nivolumab: This drug (also known as BMS-936558-01) is an immunotherapy that helps the body’s immune system attack cancer cells. The combination of BMS-986340 and nivolumab is being tested to see if it’s more effective than BMS-986340 alone[1].
  • Docetaxel: This is a type of chemotherapy drug. The combination of BMS-986340 and docetaxel is being studied to see if it provides better results than either drug on its own[1].

Understanding Pharmacokinetics of BMS-986340

The study is also looking at how BMS-986340 behaves in the body, both when given alone and in combination with other drugs. This includes measuring:

  • Maximum concentration (Cmax): The highest level of the drug in the blood
  • Time to maximum concentration (Tmax): How long it takes to reach the highest level
  • Area under the concentration-time curve (AUC): A measure of the total exposure to the drug over time
  • Concentration at the end of the dosing interval (Ctau): The level of drug just before the next dose is given

These measurements help researchers understand how the body processes the drug and how long it remains active[1].

The study is also checking for the development of anti-drug antibodies. These are proteins that the body might produce in response to the drug, which could potentially affect how well the treatment works[1].

Aspect Details
Drug Name BMS-986340
Study Type Phase 1/2 clinical trial
Study Purpose Assess safety, tolerability, and recommended dose(s) of BMS-986340
Treatment Approaches Monotherapy, combination with nivolumab, combination with docetaxel
Target Conditions Various advanced solid tumors (e.g., gastric, colorectal, lung, head and neck cancers)
Primary Outcomes Incidence of adverse events, serious adverse events, dose-limiting toxicities
Secondary Outcomes Pharmacokinetics, anti-drug antibodies, objective response rate, disease control rate, duration of response, progression-free survival rate
Evaluation Criteria RECIST v1.1
Evaluation Timeframes 6 months, 12 months

FAQ

  • What is BMS-986340? BMS-986340 is an investigational drug being studied for the treatment of advanced solid tumors. It is currently undergoing clinical trials to assess its safety, tolerability, and effectiveness in cancer patients.
  • What types of cancer is BMS-986340 being tested for? BMS-986340 is being tested for various types of advanced solid tumors, including gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, non-small-cell lung cancer, head and neck cancer, renal cell carcinoma, urothelial carcinoma, pancreatic adenocarcinoma, ovarian cancer, and triple-negative breast cancer.
  • How is BMS-986340 being administered in the clinical trial? BMS-986340 is being studied as a monotherapy (given alone) and in combination with other drugs, specifically nivolumab and docetaxel. The trial includes different parts to evaluate these various treatment approaches.
  • What are the main objectives of the BMS-986340 clinical trial? The main objectives of the trial are to assess the safety and tolerability of BMS-986340, determine the recommended dose, and evaluate its effectiveness in treating advanced solid tumors. The study also aims to understand how the drug behaves in the body (pharmacokinetics) and its potential side effects.
  • How is the effectiveness of BMS-986340 being measured in the trial? The effectiveness of BMS-986340 is being measured through various outcomes, including objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and progression-free survival rate (PFSR). These measurements will be assessed at 6 and 12 months using standard criteria for evaluating solid tumors (RECIST v1.1).

Ongoing Clinical Trials on Bms-986340

  • Study of BMS-986340, Nivolumab, and Docetaxel for Adults with Advanced or Metastatic Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany Italy Spain

Glossary

  • Advanced Solid Tumors: Cancers that have spread beyond their original site to other parts of the body and are typically difficult to treat.
  • Monotherapy: Treatment using a single drug or method.
  • Nivolumab: An immunotherapy drug that helps the immune system fight cancer cells.
  • Docetaxel: A chemotherapy drug used to treat various types of cancer.
  • Dose Escalation: A method of increasing the dose of a drug to determine the optimal safe dose.
  • Dose Expansion: A phase of clinical trials where more patients receive the drug at the determined safe dose to further evaluate its effects.
  • Adverse Events (AEs): Any unfavorable or unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, or cause significant disability.
  • Dose-Limiting Toxicity (DLT): Side effects severe enough to prevent an increase in drug dosage or require a dosage reduction.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Progression-Free Survival Rate (PFSR): The percentage of patients whose disease does not worsen for a specified time period after treatment.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.

References