What is BLU-924 studying for advanced solid tumors with KRAS mutations?

BLU-924 is being studied to evaluate its safety, tolerability, how it behaves in the body, and its antitumor activity in advanced cancers with KRAS mutations. Researchers want to understand how this drug might work in pancreatic, lung, or colorectal cancers. Blueprint Medicines Corporation is leading this research.

Who may be eligible for this advanced solid tumor clinical trial?

Adults 18 years or older with metastatic pancreatic, lung, or colorectal cancer that has a specific KRAS mutation may be eligible. Participants should have measurable disease, good performance status, and have received standard treatments unless unable. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07629960

Phase 12 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

Research Sites

95 weeks

Total Duration

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 12 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 drugs 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

Age: 18Years +

All Genders

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

Research Team

Blueprint Medicines

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