In short
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.
At a glance
- 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
What is BMS-986340?
BMS-986340 is a new drug that is currently being investigated for the treatment of various advanced solid tumors. 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.
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.
How is BMS-986340 being studied?
The clinical trial for BMS-986340 is divided into several parts:
- 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.
- 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.
- Part 1C: This part examines BMS-986340 in combination with a chemotherapy drug called docetaxel.
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).
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.
- Effectiveness: The study is measuring how well the drug works against tumors. This includes looking at: These measures will be assessed at 6 months and 12 months after treatment starts.
- 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
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.
- 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.
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.
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.