Clinical Trial 24291

• Overview

  Study Title:

  A Phase 1/2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants with Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations

  Summary:

  The main purpose of this study is to see how safe and tolerable BLU-924 is in participants. 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).

  Objective:

  Dose Escalation and Dose Enrichment Primary objectives: - To evaluate the safety and tolerability of BLU-924 monotherapy - To establish the MTD and/or RDFE of BLU-924 monotherapy Secondary objectives: - To assess the preliminary evidence of antitumor activity following administration of BLU-924 monotherapy - To characterize the PK profile of BLU-924 monotherapy Dose Expansion Primary objectives: - To evaluate the safety and tolerability of BLU-924 monotherapy - To assess the antitumor activity of BLU-924 monotherapy at the RDFE Secondary objectives: - To further assess the antitumor activity of BLU-924 monotherapy at the RDFE - To further characterize the PK profile of BLU-924 monotherapy Dose Escalation, Dose Enrichment, and Dose Expansion Exploratory objective: - To characterize the pharmacodynamic activity of BLU-924 and relationship to study intervention exposure, antitumor activity, and resistance

• Treatments

  Therapies:

  pan-KRAS inhibitor

  Medications:

  BLU-924 ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • 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).
  • Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.