BMS-986517 for Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- Participants must be at least 18 years of age at the time of signing the ICF."}
• {"criterion_text":"- They must have at least one measurable lesion and should be in good overall health, able to carry out most regular daily tasks."}
• {"criterion_text":"- Participants must have advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The types of cancer include lung, head and neck, triple-negative breast cancer, and a certain kind of hormone receptor-positive breast cancer."}
• {"criterion_text":"- Participants must have already received treatment for their advanced cancer."}

Exclusion criteria

• {"criterion_text":"- Untreated CNS metastases will be excluded. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment)."}
• {"criterion_text":"- Concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment will be excluded."}
• {"criterion_text":"- Participants with history of serious recurrent infections will be excluded."}
• {"criterion_text":"- Participants with impaired cardiac function or history of severe heart disease."}

Primary endpoints

• {"endpoint_text":"- To monitor how often side effects that meet specific criteria (known as Dose Limiting Toxicities, DLTs) happen during the first 21 days from the first dose and how often side effects, serious side effects, DLTs, side effects causing treatment to stop, or deaths happen until 30 days after the last treatment.","definition_or_measurement_approach":"DLTs monitored during the first 21 days from first dose; monitoring of AEs/SAEs/DLTs/ treatment discontinuation events and deaths up to 30 days after last treatment."}

Secondary endpoints

• {"endpoint_text":"- To track whether participants’ tumors shrink and how long such responses last, as judged by study doctors, up to 3 years from the first treatment and monitor how BMS-986517 and its main components move through and are processed by the body up to 30 days after the last treatment.","definition_or_measurement_approach":"Tumor response and duration assessed by study doctors up to 3 years from first treatment; pharmacokinetics of BMS-986517 and components assessed up to 30 days after last treatment."}

Denmark

Earliest CTIS Part Ii Submission Date

29-10-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

9

Number Of Sites

3

Number Of Participants

11

Spain

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

11

Number Of Sites

8

Number Of Participants

18

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Third parties

• {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"ECG analysis / review","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Illumina Inc.","duties_or_roles":"Plasma for ctDNA","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"TS and BioA","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
• {"country":"United States","full_name":"Canopy Biosciences LLC","duties_or_roles":"Spatial Transcriptomics from Tumor Tissue (bock/slide)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology, serology/endocrinology, medical image analysis / review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for biomarker samples (no genetic analysis)","organisation_type":"Pharmaceutical company"}