A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Start
- 2026-06-04
- End
- 2031-07
- Enrollment
- 265
- Sites
- 16
- Sponsor class
- INDUSTRY
Not in the data yet: a trial card. A one-glance card (population, design, endpoints, result, each tied to a quote) is not built yet. The fields above are registry or bibliographic metadata, not quotes.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you get that instead of a guess.
Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: BLU-924. Tablet
Arm · public domain (ClinicalTrials.gov) · T1
Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose Expansion (experimental): Participants will receive BLU-924 oral tablet, once daily as monotherapy during Dose Escalation followed by Dose Enrichment. During Dose Enrichment, participants with PDAC, NSCLC or CRC will receive BLU-924 at selected dose levels below the current escalation dose or, if Dose Escalation is complete, below the MTD. During Dose Expansion, participants will receive RDFE of BLU-924 oral tablet, once daily as monotherapy determined during escalation monotherapy part. Dose Expansion may be initiated to further assess the safety, antitumor activity, PK, and pharmacodynamics of BLU-924 at RDFE in indication-specific cohorts (PDAC, NSCLC, or CRC) harboring a KRAS mutation.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs). 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. Time frame: Up to 5 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs. 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. Time frame: Up to 5 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924. Time frame: Up to 5 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924. Time frame: Up to 5 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Expansion: Overall Response Rate (ORR). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation and Enrichment: Overall Response Rate (ORR). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation, Enrichment, and Expansion: Duration of Response (DOR). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation, Enrichment, and Expansion: Disease Control Rate (DCR). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation, Enrichment and Expansion: Progression-free Survival (PFS). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Expansion: Overall Survival (OS). Time frame: Up to 5 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Dose Escalation, Enrichment and Expansion: AUC - Area Under the Plasma Concentration Time Curve for BLU-924. Time frame: Up to 2 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
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.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 265 participants (estimated).