Study on the Safety and Initial Effectiveness of GSK5460025 Alone or with Other Cancer Treatments in Patients with Solid Tumors

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07213609

This clinical trial is exploring whether the drug GSK5460025, used alone or with other cancer treatments, can safely reduce the size of solid tumors that have specific genetic traits making them harder to treat.

Patient Parameters

Program Overview

Solid tumors are abnormal growths that can appear in various parts of the body. This study focuses on tumors with certain genetic features that make them more aggressive and difficult to treat. The trial will test if GSK5460025, either by itself or combined with other cancer drugs, can safely shrink these tumors and how the body processes the drug over time.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor that cannot be removed by surgery, has spread, or has come back.
  • Have a specific genetic status (dMMR/MSI-H) confirmed by a lab test, or be willing to have this status tested.
  • Provide a sample of the tumor tissue, either from a previous biopsy or a new one.
  • Plan to use GSK5460025 as the next treatment option.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of at least 3 months.
  • Have good organ function as specified in the study.

Part 1 inclusion criteria:

  • Have an advanced solid tumor and have tried all standard treatment options.

Part 2 inclusion criteria:

  • Have advanced colorectal or endometrial cancer.
  • Have received 1 to 3 previous cancer treatments, including at least one immune therapy.
  • Have at least one measurable tumor during the screening period.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments.
  • Have previously been treated with a Werner inhibitor or NERT agent.
  • Cannot swallow pills or keep them down.
  • Have untreated or worsening cancer in the brain or central nervous system.
  • Have another cancer that has progressed or needed treatment in the last 2 years, except for certain skin cancers or in situ cancers that have been removed.
  • Have digestive issues that could affect how the study drugs are absorbed.
  • Have liver cirrhosis or unstable liver or bile duct disease.
  • Have allergies to any of the study drugs or their ingredients.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site44718CantonOhio
GSK Investigational Site37203NashvilleTennessee

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