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Clinical Trials in the USA / NCT07223047
Recruiting Phase 1/2

A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

NCT07223047 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/2
Started
2025-11-25
Last updated
2026-05-28

Condition(s) studied

Advanced Solid MalignanciesNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)

Investigational drug(s) / intervention(s)

BMS-986523GemcitabineNab-PaclitaxelCetuximabPembrolizumab

BMS-986523: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Nab-Paclitaxel: Specified dose on specified days

Cetuximab: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted. * Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Johns Hopkins Hospital Baltimore Maryland Recruiting
NEXT Oncology San Antonio Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
BC Cancer Vancouver Vancouver British Columbia Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Local Institution - 0006 Badalona Barcelona [Barcelona] Not Yet Recruiting
Local Institution - 0008 Hortaleza Madrid Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223047 on ClinicalTrials.gov ↗ ← All trials in the USA