First-in-human test of BLU-924 for KRAS-mutant advanced cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label Phase 1/2 study evaluating BLU-924 as a single agent in patients with metastatic KRAS-mutant pancreatic, lung, or colorectal cancer. The study progresses from dose escalation to enrichment and expansion cohorts to identify a safe dose and to characterize safety, PK, PD, and early signs of activity. Participants are monitored for dose-limiting toxicities and response, with disease-specific cohorts enabling more precise assessment of activity. No combination therapies are used in this protocol at this time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Florida Cancer Specialists & Research Institute - Sarasota
  Sarasota, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Next Oncology Virginia Cancer Specialist
  Fairfax, Virginia, United States Recruiting
• Mary Bird Perkins Cancer Center
  Baton Rouge, Louisiana, United States Not yet recruiting
• Massachusetts General Hospital - Main Campus
  Boston, Massachusetts, United States Not yet recruiting
• University of Michigan Medical School Rogel Cancer Center
  Ann Arbor, Michigan, United States Not yet recruiting

Study contacts

• Study coordinator: Blueprint Medicines
• Email: medinfo@blueprintmedicines.com
• Phone: 1-888-258-7768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.