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RECRUITING
NCT07629960
PHASE1/PHASE2

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

Sponsor: Blueprint Medicines Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2026-06-04

Completion Date

2031-07

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

BLU-924

Tablet

Locations (16)

Florida Cancer Specialists & Research Institute - Sarasota

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Massachusetts General Hospital - Main Campus

Boston, Massachusetts, United States

University of Michigan Medical School Rogel Cancer Center

Ann Arbor, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Langone Health Perlmutter Cancer Center

New York, New York, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, United States

Next Oncology Virginia Cancer Specialist

Fairfax, Virginia, United States

Mi Cancer Center Barcelona (Pratia Sirius Barcelona)

Barcelona, Catalonia, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital General Universitrio Gregorio Maranon

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

NEXT Oncology - Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad de Navarra (CUN)

Pamplona, Navarre, Spain