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Colorectal Neoplasms / Advanced Solid Tumor / BLU-924 · Phase 1/2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human phase 1/2 registration for BLU-924 (SAR449336), a pan-KRAS inhibitor, in KRAS-mutant advanced solid tumors. The study is currently recruiting and has not yet posted results; it is designed to establish maximum tolerated dose, recommended expansion dose, safety profile, and preliminary antitumor activity over up to 5 years of follow-up.
Phase 1/2, Interventional, Sequential, Open label, Treatment purpose. Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma; age from 18 Years. Intervention: Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment,…. n = 265. 2 sites: United States.
Planned enrollment: 265 participants with advanced pancreatic, non-small cell lung, or colorectal cancer harboring KRAS mutations Primary endpoints include dose-limiting toxicity percentage, treatment-emergent adverse event incidence and severity, maximum tolerated dose, recommended dose for expansion, and overall response rate
No published efficacy, safety, or pharmacokinetic data are available Primary endpoints include dose-limiting toxicity percentage, treatment-emergent adverse event incidence and severity, maximum tolerated dose, recommended dose for expansion, and overall response rate
This registration indicates an active first-in-human investigation of a novel pan-KRAS inhibitor. Clinicians should monitor for results from this trial, as KRAS-mutant cancers represent a significant clinical need; however, no efficacy or safety data are yet available from this registry record.
This is a first-in-human, phase 1/2 trial registration with no results posted; the study is actively recruiting and designed to establish safety, tolerability, and initial antitumor activity of a novel pan-KRAS inhibitor.
As stated by the source record.
Quoted from the source exactly as published.
This registration indicates an active first-in-human investigation of a novel pan-KRAS inhibitor. Clinicians should monitor for results from this trial, as KRAS-mutant cancers represent a significant clinical need; however, no efficacy or safety data are yet available from this registry record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07629960). This is a study registration, not published results. Lead sponsor: Blueprint Medicines Corporation. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 265 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma. Interventions: DRUG: BLU-924. Primary outcome measures: Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs) , Up to 5 years; Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs , Up to 5 years; Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924 , Up to 5 years; Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924 , Up to 5 years; Dose Expansion: Overall Response Rate (ORR) , Up to 5 years. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.