Actively Recruiting
Phase 1/2 Trial of BLU-924 (SAR449336) Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity in Advanced Pancreatic, Lung, and Colorectal Cancers with KRAS Mutations
Led by Blueprint Medicines Corporation · Updated on 2026-06-05
265
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
B
Blueprint Medicines Corporation
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying BLU-924 (SAR449336), a pan-KRAS inhibitor, in people with advanced pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer that have specific KRAS mutations. This open-label Phase 1/2 trial aims to assess the safety, tolerability, how the drug moves in the body, and its antitumor effects in these cancers. Participants will receive BLU-924 as a daily oral tablet during different study periods: Dose Escalation, Dose Enrichment, and Dose Expansion. Dose Escalation and Dose Enrichment focus on identifying side effects and the best dose for further study. Dose Expansion will further evaluate the safety and activity of the chosen dose in specific cancer groups. Throughout the trial, participants will undergo regular evaluations including monitoring for side effects, tumor response, and drug levels in the body. The study will measure how many participants experience dose-limiting toxicities, overall response rates, and other outcomes up to five years. This long-term follow-up will help understand the drug’s effects and safety over time.
CONDITIONS
Brief Title
A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed metastatic pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer with a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Received all standard therapies for metastatic cancer unless medically unable to do so
You will not qualify if you...
- History of another cancer within the past 2 years, except as allowed in the protocol
- Active brain metastases (asymptomatic brain metastases may be allowed)
- Prior treatment with KRAS-targeting therapies including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, or KRAS degraders
- Active or uncontrolled infections such as tuberculosis, Hepatitis B, Hepatitis C, or HIV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive BLU-924 oral tablet once daily as monotherapy during Dose Escalation, Dose Enrichment, and Dose Expansion phases. The treatment aims to evaluate safety, tolerability, pharmacokinetics, and antitumor activity in participants with metastatic pancreatic, lung, or colorectal cancers harboring KRAS mutations.
Visits scheduled according to phase and dosing requirements
Trial Site Locations
Total: 1 location
1
Next Oncology Virginia Cancer Specialist
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
B
Blueprint Medicines
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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