BLU-924 for advanced pancreatic, lung or colorectal cancer with KRAS mutations
Tests BLU-924, a KRAS inhibitor, in adults with advanced KRAS-mutated cancers.
Plain-language title generated from the registry record
Registry title: A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
Key facts
- Where
- Ann Arbor, Baton Rouge, Boston, Fairfax, Hackensack, Houston, Nashville, New York, Sarasota, and Tampa, United StatesSee the 10 sites
- Phase
- Phase 1/2
Where in United States
- University of Michigan Medical School Rogel Cancer CenterAnn Arbor, United StatesNot yet recruiting
- Mary Bird Perkins Cancer CenterBaton Rouge, United StatesNot yet recruiting
- Massachusetts General Hospital - Main CampusBoston, United StatesNot yet recruiting
- Next Oncology Virginia Cancer SpecialistFairfax, United StatesTaking people
- Hackensack University Medical CenterHackensack, United StatesNot yet recruiting
- The University of Texas MD Anderson Cancer Center - Texas Medical CenterHouston, United StatesNot yet recruiting
- Tennessee Oncology, PLLCNashville, United StatesNot yet recruiting
- NYU Langone Health Perlmutter Cancer CenterNew York, United StatesNot yet recruiting
- Florida Cancer Specialists & Research Institute - SarasotaSarasota, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Blueprint Medicines Corporation
- Trial code
- NCT07629960
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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); Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; 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: Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders; History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol; 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; Active brain metastases (participants with asymptomatic brain metastases may be eligible).