A study to evaluate the safety and effectiveness of BMS-986523 alone or in combination with a drug combination for patients with advanced solid tumors and KRAS alterations.

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of the drug BMS-986523 in patients with Advanced Solid Tumor Malignancies, which are types of cancer that have formed masses in the body and have spread. The research focuses on cases where there are KRAS alterations, which are specific changes or mutations in the genes that help control cell growth. The study will look at how the drug works when used alone or when combined with other treatments such as pembrolizumab, cetuximab, or gemcitabine and nab-paclitaxel.

Participants in the study may receive the experimental medication as a single treatment or alongside other anti-cancer agents. During the trial, researchers will monitor how the body processes the medicine and how the drug moves through the bloodstream. The investigation aims to determine the most effective dose and schedule for the treatment while watching for any side effects that may occur.

Who Can Join the Study?

You must have a confirmed diagnosis of a solid tumor, which is a type of cancer that forms a lump or mass in the body, that is either locally advanced (has spread within the area where it started) or metastatic (has spread to other parts of the body).
The cancer must be unresectable, meaning it cannot be removed by surgery.
Your cancer must have a known KRAS alteration, which means there is a specific change or error in the KRAS gene (a part of your DNA that helps control how cells grow).
Depending on the specific part of the study you are assigned to, the cancer type may be limited to NSCLC (a type of lung cancer), CRC (colon cancer), or PDAC (a type of pancreatic cancer).
You must have already received certain standard of care treatments (the usual treatments doctors provide for your condition), or you must be unable to take them, or you must have chosen not to take them after being fully informed about the options.
The study is open to both males and females.
You must fall within the specific age range required for this study.

Who Cannot Join the Study?

You cannot join if you have untreated central nervous system (CNS) metastases, which means cancer that has spread to the brain or spinal cord and has not yet been treated.
You cannot participate if you have another type of cancer that needs treatment right now, or if you have had cancer that was active within the last 2 years.
You cannot join if you have previously taken any (K)RAS directed therapy, which refers to medicines specifically designed to target a certain type of genetic change in cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country	Status
Iwicvbsy Cqggnq Dbzszepphjgbivvmt	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	24.05.2026

Trial locations

BMS-986523 is an experimental medicine being tested to see if it is safe and effective for treating advanced types of solid cancer. In this study, it may be given by itself or used together with other cancer treatments.

Advanced solid tumor malignancies – These are types of cancer that form in organs or tissues rather than in the blood or bone marrow. These tumors develop from abnormal cell growth that has spread or become more extensive within the body. The disease involves cells that have acquired specific genetic changes, such as alterations in the KRAS gene. As the condition progresses, the cancerous cells multiply and can expand into surrounding healthy tissues. The tumors can also move from their original location to other parts of the body.

Trial ID:

2025-523547-35-00

Protocol code:

CA2560001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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A study to evaluate the safety and effectiveness of BMS-986523 alone or in combination with a drug combination for patients with advanced solid tumors and KRAS alterations.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?