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A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations

RecruitingPhase 1/2

A Phase 1/2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).
2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.

Exclusion Criteria:

1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.
2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).
3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.
4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

About the study

A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.

What is being tested

Sponsor: Blueprint Medicines Corporation · Participants: 265 · Started: Jun 4, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07629960

Locations in the U.S.

FloridaFlorida Cancer Specialists & Research Institute - Sarasota, Sarasota
Moffitt Cancer Center, Tampa
LouisianaMary Bird Perkins Cancer Center, Baton Rouge (Not yet recruiting)
MassachusettsMassachusetts General Hospital - Main Campus, Boston (Not yet recruiting)
MichiganUniversity of Michigan Medical School Rogel Cancer Center, Ann Arbor (Not yet recruiting)
New JerseyHackensack University Medical Center, Hackensack (Not yet recruiting)
New YorkNYU Langone Health Perlmutter Cancer Center, New York (Not yet recruiting)
TennesseeTennessee Oncology, PLLC, Nashville (Not yet recruiting)
TexasThe University of Texas MD Anderson Cancer Center - Texas Medical Center, Houston (Not yet recruiting)
VirginiaNext Oncology Virginia Cancer Specialist, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.