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

Study of an Investigational Study Drug for Metastatic KRAS-Mutant Cancers

Age
18 years or above
Gender
All
Phase
Phase 1/2
Participants needed
265
Locations
3
Find a study site near you

Study Overview

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.

Study Details

This is an open-label, multi-center, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of BLU-924, a pan-KRAS inhibitor, in participants with metastatic KRAS mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC). The monotherapy part of the study includes Dose Escalation, Dose Enrichment, and Dose Expansion. Participants enrolled during Dose Escalation and Dose Enrichment will be evaluated for dose limiting toxicities (DLTs) to determine the MTD. Participants enrolled into disease-specific Enrichment cohorts will enable a more robust characterization of safety, PK, pharmacodynamics, and preliminary clinical activity. Enrolment into Dose Expansion will follow the identification of at least 1 recommended dose for expansion (RDFE) based on data from the Dose Escalation and Dose Enrichment. No combination arm is active at this time.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
  • Age: 18 years or above
  • Gender: All

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.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in adults with metastatic (spread) pancreatic cancer, non-small cell lung cancer, or colorectal cancer that has a KRAS mutation.

Participants will receive the investigational study drug by itself. The study team will also watch for side effects and measure drug levels in the body (pharmacokinetics).

Who can participate:
Adults with metastatic pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer may be able to participate if they:

  • Have a KRAS mutation in their cancer (found in tumor tissue or in blood testing for tumor DNA)
  • Have cancer that can be measured on scans
  • Are able to do most daily activities (good overall physical functioning)
  • Have already received standard treatments for their cancer type for metastatic disease, unless they cannot receive them for medical reasons

Updated on 21 Aug 2026. Study ID: NCT07629960

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.