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A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
Sponsor: Blueprint Medicines Corporation
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
Conditions
Interventions
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