A Phase 1/2a Study of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies

Overview

Sponsor-declared trial summary

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]

Decision date (initial)

2026-04-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523547-35-00

WHO UTN

U1111-1329-2476

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To find out if BMS-986523 is safe and tolerable and to figure out the best dose and schedule for using BMS-986523 alone or with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in participants with advanced solid malignancies that have KRAS alterations.

Secondary objectives 2

1. To see how well BMS-986523 works on its own and when combined with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in participants with advanced solid malignancies that have KRAS alterations.
2. To understand how BMS-986523 moves through and is processed by the body after it’s taken by mouth alone or when combined with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in participants with advanced solid malignancies that have KRAS alterations.

Conditions and MedDRA coding

Advanced Solid Tumor Malignancies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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).
2. 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 3

1. Untreated central nervous system (CNS) metastases.
2. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
3. Prior treatment with a (K)RAS directed therapy including approved treatments and investigational agents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 2

1. Overall response rate to BMS-986523 and how long that response lasts based on RECIST v1.1 as judged by the study doctor.
2. 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.

Investigational products

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

Test 2

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 8

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications