First Human Trial of BLU-924 for Advanced Cancers with KRAS Mutations

Sponsor: Blueprint Medicines Corporation

Sponsor score: 40

ClinicalTrials ID:NCT07629960

This clinical trial is testing a new drug, BLU-924, to see if it is safe and effective in treating advanced pancreatic, lung, or colorectal cancers that have specific KRAS mutations.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of BLU-924, a new drug targeting KRAS mutations, in patients with advanced pancreatic, non-small cell lung, or colorectal cancer. Researchers will assess how well the drug works, how the body processes it, and any side effects it may cause.

Description

This trial is the first to test BLU-924, a drug designed to target KRAS mutations, in humans. It involves patients with advanced pancreatic, lung, or colorectal cancer that have specific KRAS mutations. The study is divided into several parts:

  • Dose Escalation: To find the safest dose by gradually increasing the amount given to participants.
  • Dose Enrichment: To gather more detailed information on safety and how the drug behaves in the body.
  • Dose Expansion: To further explore the drug's effects at a recommended dose.

Participants will be closely monitored for side effects and how their cancer responds to the treatment. The study does not currently include testing BLU-924 in combination with other treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced pancreatic, lung, or colorectal cancer with a specific KRAS mutation.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have already tried all standard treatments for their cancer type, unless unable to do so for medical reasons.

Exclusion Criteria

  • Have had another type of cancer within the last 2 years, with some exceptions.
  • Have active cancer that has spread to the brain, unless it is not causing symptoms.
  • Have previously received treatments specifically targeting KRAS mutations.
  • Have active or uncontrolled infections like tuberculosis, hepatitis B or C, or HIV.

Locations

FACILITYZIPCITYSTATE
Next Oncology Virginia Cancer Specialist22031FairfaxVirginia

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