RecruitingPhase 1 / Phase 2NCT07629960
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBLU-924

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?Blueprint Medicines Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Blueprint Medicines Corporation
Interventions being studied
Drug: BLU-924
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer Specialists & Research Institute - SarasotaSarasota, Florida
  • Moffitt Cancer CenterTampa, Florida
  • Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana
  • Massachusetts General Hospital - Main CampusBoston, Massachusetts
  • University of Michigan Medical School Rogel Cancer CenterAnn Arbor, Michigan
  • Hackensack University Medical CenterHackensack, New Jersey
  • NYU Langone Health Perlmutter Cancer CenterNew York, New York
  • Tennessee Oncology, PLLCNashville, Tennessee
  • The University of Texas MD Anderson Cancer Center - Texas Medical CenterHouston, Texas
  • Next Oncology Virginia Cancer SpecialistFairfax, Virginia
  • Mi Cancer Center Barcelona (Pratia Sirius Barcelona)Barcelona, Catalonia
  • Hospital Universitario Vall d'HebronBarcelona, Catalonia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2026. Always confirm current availability with the study team.

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