In short
BMS-986523 is an investigational chemical substance being studied as an oral film-coated tablet for advanced solid tumour malignancies. It has no marketing authorisation and is supplied by Bristol-Myers Squibb International Corporation. One authorised Phase 1/2 trial (2025-523547-35-00) plans to enrol 252 participants to test the drug alone and with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in tumours with KRAS alterations.
Key points
- BMS-986523 is an investigational oral drug with no marketing authorisation.
- It is being studied in advanced solid tumour malignancies with KRAS alterations.
- The only registered trial is Phase 1/2 and plans to enrol 252 participants.
- The trial tests BMS-986523 alone and in combination with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel.
- The main goal is to measure safety, tolerability, and the best dose, including dose-limiting toxicities.
- The study is currently authorised in the EU Clinical Trials Information System.
What is BMS-986523?
BMS-986523 is an investigational chemical substance developed by Bristol-Myers Squibb International Corporation. It is a chemically synthesised small molecule that has not received marketing authorisation, meaning it is not yet approved as a medicine. The substance appears in the EU Clinical Trials Information System under the product name BMS-986523 and is being investigated for advanced solid tumour malignancies. BMS-986523 is classified in the therapeutic area of neoplasms, which covers cancers and other abnormal tissue growths.
How does BMS-986523 work?
The registry data do not describe the molecular target or mechanism of action of BMS-986523. The trial summary states that the study focuses on participants whose advanced solid tumours have KRAS alterations, which suggests the drug may be relevant to cancers driven by changes in the KRAS gene, but no further detail on how BMS-986523 acts is provided in the available sources.
Which conditions is BMS-986523 being studied for?
- Advanced solid tumour malignancies — cancers that have spread locally or to other parts of the body and cannot be removed by surgery alone, specifically those with KRAS alterations.
How is BMS-986523 given?
BMS-986523 is given as a film-coated tablet for oral use, meaning it is swallowed by mouth. The trial tests the drug as monotherapy and in combination with other anti-cancer agents, but the registry does not report the specific dose or schedule.
What do the clinical trials show?
One clinical trial is registered for BMS-986523: a Phase 1/2 study (2025-523547-35-00) that is currently authorised in the EU. The trial plans to enrol 252 participants with advanced solid malignancies that have KRAS alterations. The study is interventional and tests BMS-986523 alone as well as in combination with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel. The primary outcome measures safety and tolerability, including how often side effects occur, serious side effects, dose-limiting toxicities, and side effects that lead to stopping treatment or death. The study also aims to determine the best dose and schedule for BMS-986523.
What side effects are known?
No side effect data are available from the registry at this stage. The trial is designed to measure side effects as its primary outcome, but results have not been reported in the provided sources.