BMS-986523 for Advanced solid tumor malignancies

Inclusion criteria

• {"criterion_text":"- Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known KRAS alteration (mutation or amplification): Part 1A: All tumor types (Arms A and B); Part 2A: NSCLC, CRC, and PDAC (Arm C); Part 1B: NSCLC (Arm D), CRC (Arm E), and PDAC (Arm F).\n- Participants should have previously received, be ineligible for, or declined (after having been provided adequate information to make an informed decision) select standard of care treatments depending on their assigned study arm."}

Exclusion criteria

• {"criterion_text":"- Untreated central nervous system (CNS) metastases.\n- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.\n- Prior treatment with a (K)RAS directed therapy including approved treatments and investigational agents."}

Primary endpoints

• {"endpoint_text":"- How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.","definition_or_measurement_approach":"Safety assessed by reporting of adverse events, including serious adverse events, events meeting dose-limiting toxicity (DLT) criteria per study rules, and treatment discontinuations or deaths (as described in the endpoint text)."}

Secondary endpoints

• {"endpoint_text":"- Overall response rate to BMS-986523 and how long that response lasts based on RECIST v1.1 as judged by the study doctor.","definition_or_measurement_approach":"Tumor response assessed by RECIST v1.1 as judged by the investigator; duration of response measured from first documented response until progression or death."}
• {"endpoint_text":"- How BMS-986523 moves through and is processed by the body, including the highest level of the drug in the blood (Cmax), how long it takes to reach that level (Tmax), and overall exposure (AUC), based on blood tests over time.","definition_or_measurement_approach":"Pharmacokinetic measures including Cmax, Tmax, and AUC determined from serial blood sampling and bioanalytical assays over time."}

Spain

Earliest CTIS Part Ii Submission Date

10-02-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

78

Number Of Sites

2

Number Of Participants

16

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Perceptive Informatics Inc.

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound, etc, Imaging Analysis

Name

Mosaic Laboratories LLC

Responsibilities

Biomarker (IHC on paired biopsies)

Name

Medidata Solutions Inc.

Responsibilities

Data management platform

Name

Endpoint Clinical Inc.

Responsibilities

IVRS – treatment randomisation Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment

Name

Azenta Germany GmbH

Responsibilities

Sample storage for CA256-0001

Name

Iqvia Inc.

Responsibilities

Site payments and multiple operational responsibilities

Name

Accenture Solutions Private Limited

Responsibilities

Embarc operations

Name

Pharmaceutical Product Development LLC

Responsibilities

Clinical laboratory and PK bioanalysis services (detailed duties listed)

Third parties

• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc, Imaging Analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Biomarker (IHC on paired biopsies)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data management platform","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Other - IVRS – treatment randomisation Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for CA256-0001","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Multiple operational duties including Site payments (other duties indicated by codes but not fully described)","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"clinical chemistry, clinical haematology, clinical microbiology, serology/ endocrinology, medical image analysis/ review - x ray, MRI, ultrasound, etc, PK Bioanalysis -PK Blood Sample and 4-Beta Hydroxycholesterol Blood Sample (Part 1A only)","organisation_type":"Pharmaceutical company"}