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.
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).
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
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.
History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.
Active brain metastases (participants with asymptomatic brain metastases may be eligible).
Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.
Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).
Sequential
BLU-924
DrugTablet
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.
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.
Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924
Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924
Dose Escalation and Enrichment: Overall Response Rate (ORR)
Dose Escalation, Enrichment, and Expansion: Duration of Response (DOR)
Dose Escalation, Enrichment, and Expansion: Disease Control Rate (DCR)
Dose Escalation, Enrichment and Expansion: Progression-free Survival (PFS)
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Blueprint Medicines Corporation
Lead sponsor
Sanofi
Collaborator
