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

Investigational Medication Study for Advanced Solid Tumors with KRAS Mutations

Recruiting
18 years or above
All
Phase 1/2
265 participants needed
1 Location

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.

This study investigates advanced pancreatic cancer, non-small cell lung cancer, and colorectal cancer with KRAS mutations. The purpose of this study is to explore how the investigational medication affects these conditions.

The study evaluates the safety, tolerability, and other effects of the investigational medication. It looks at how the body processes the medication and its potential impact on the tumors.

  • Who can participate: Adults with metastatic pancreatic, lung, or colorectal cancer that have specific KRAS mutations can participate. They must have measurable disease and a good performance status. Participants should have tried all standard treatments unless unable to due to medical reasons.
  • Study details: Participants will take the investigational medication to assess its effects. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, is not used in this study.
Updated on 01 Jun 2026. Study ID: NCT07629960

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