A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants with Advanced Solid Tumors

Start 18 Dec 2025 · Status Ongoing, recruiting · 2 EU/EEA countries · 10 sites · Protocol CA2540001

Overview

Sponsor-declared trial summary

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

Status Ongoing, recruiting

Participants planned 58

Countries 2

Sites 10

Advanced Solid Tumors

To find out what doses of BMS-986517 are safe and how much people can tolerate in order to choose the best dose(s) for future use (Part 1) and check if giving BMS-986517 at the chosen dose(s) continues to be safe for people with specific cancers (Part 2).

Key facts

Sponsor: Bristol-Myers Squibb Services Unlimited Company
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 18 Dec 2025 → ongoing
Decision date (initial): 2025-11-07
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number: 2025-522203-23-00
WHO UTN: U1111-1322-1627

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Dose response, Pharmacodynamic, Efficacy

Secondary objectives 1

To see if BMS-986517 helps shrink or control tumors in people with these cancers and learn how BMS-986517 moves and changes in the body.

Conditions and MedDRA coding

Advanced Solid Tumors

Version	Level	Code	Term	System organ class
21.1	LLT	10065252	Solid tumor	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Participants must be at least 18 years of age at the time of signing the ICF.
They must have at least one measurable lesion and should be in good overall health, able to carry out most regular daily tasks.
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.
Participants must have already received treatment for their advanced cancer.

Exclusion criteria 4

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).
Concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment will be excluded.
Participants with history of serious recurrent infections will be excluded.
Participants with impaired cardiac function or history of severe heart disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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.

Secondary endpoints 1

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

BMS-986517

PRD12759190 · Product

Active substance: BMS-986517
Substance synonyms: BXA-246524
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation: Bristol-Myers Squibb Services Unlimited Company
Address: Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
City: Dublin 15
Postcode: D15 T867
Country: Ireland

Scientific contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Public contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Third parties 9

Organisation	City, country	Duties
Icon Clinical Research LLC ORG-100039864	Rochester, United States	Other
Illumina Inc. ORG-100049125	San Diego, United States	Other
Perceptive Informatics Inc. ORG-100013171	Burlington, United States	Other
QPS LLC ORG-100012847	Newark, United States	Other
Nordic Bioscience A/S ORG-100009315	Herlev, Denmark	Other
Endpoint Clinical Inc. ORL-000012879	Wakefield, United States	Other
Canopy Biosciences LLC ORG-100048464	Hayward, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Highland Heights, United States	Other
Azenta Germany GmbH ORG-100022621	Griesheim, Germany	Other

Locations

2 EU/EEA countries · 10 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ongoing, recruiting	11	3
Spain	Authorised, recruiting	18	7
Rest of world United States, Japan	—	29	—

Investigational sites

Denmark

3 sites · Ongoing, recruiting

Odense University Hospital

Odense University Hospital, Department of Oncology, J. B. Winsloews Vej 4, 5000, Odense C

Region Hovedstaden

Department of Oncology, Herlev and Gentofte Hospital, Borgmester Ib Juuls Vej 1, 2730, Herlev

Rigshospitalet

Copenhagen University Hospital, Rigshospitalet, Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe

Spain

7 sites · Authorised, recruiting

Hospital Universitario Virgen De La Victoria

Medical Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga

Hospital Universitario Hm Sanchinarro

Medical Oncology, Calle Ona 10, 28050, Madrid

Hospital Universitari Vall D Hebron

Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Institut Catala D'oncologia

Medical Oncology, Carretera Canyet S/n, 08916, Badalona

Hospital Universitario Fundacion Jimenez Diaz

Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Clinica Universidad De Navarra

Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid