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Recruiting Phase 1/2

A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations

NCT07629960 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2026-06-04
Last updated
2026-09-21

Condition(s) studied

Advanced Solid TumorNon-Small Cell Lung CancerColorectal NeoplasmsPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

BLU-924

BLU-924: Tablet

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs) — Up to 5 years
    Any of the prespecified AEs that are attributable to the study treatment, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.
  • Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs — Up to 5 years
    An adverse event (AE) is any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
  • 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

Trial sites (16)

FacilityCityRegionStatus
Florida Cancer Specialists & Research Institute - Sarasota Sarasota Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Not Yet Recruiting
Massachusetts General Hospital - Main Campus Boston Massachusetts Not Yet Recruiting
University of Michigan Medical School Rogel Cancer Center Ann Arbor Michigan Not Yet Recruiting
Hackensack University Medical Center Hackensack New Jersey Not Yet Recruiting
NYU Langone Health Perlmutter Cancer Center New York New York Not Yet Recruiting
Tennessee Oncology, PLLC Nashville Tennessee Not Yet Recruiting
The University of Texas MD Anderson Cancer Center - Texas Medical Center Houston Texas Not Yet Recruiting
Next Oncology Virginia Cancer Specialist Fairfax Virginia Recruiting
Mi Cancer Center Barcelona (Pratia Sirius Barcelona) Barcelona Catalonia Not Yet Recruiting
Hospital Universitario Vall d'Hebron Barcelona Catalonia Not Yet Recruiting
Hospital General Universitrio Gregorio Maranon Madrid Madrid Not Yet Recruiting
Hospital Universitario 12 de Octubre Madrid Madrid Not Yet Recruiting
NEXT Oncology - Madrid Pozuelo de Alarcón Madrid Not Yet Recruiting
Clinica Universidad de Navarra (CUN) Pamplona Navarre Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07629960 on ClinicalTrials.gov ↗ ← All trials in the USA