Study on the Safety and Effectiveness of GSK4418959 Alone or with Other Cancer Drugs in Patients with Solid Tumors

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT06710847

Provider View

This clinical trial is testing a new drug, GSK4418959, alone or with another cancer drug, to see if it can safely reduce tumor size in patients with solid tumors that have specific genetic traits. The study will also look at how the drug is processed in the body over time.

Patient Parameters

Program Overview

Solid tumors are abnormal growths that can appear in different parts of the body. This study focuses on tumors with certain genetic features that make them more aggressive and harder to treat. Researchers are testing whether the drug GSK4418959, used alone or with a PD-1 inhibitor, can safely shrink these tumors and how the drug is broken down in the body 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 known or unknown genetic status related to tumor aggressiveness, which will be tested if unknown.
  • Provide a sample of the tumor tissue for testing.
  • Plan to receive GSK4418959, either alone or with a PD-1 inhibitor, as the next treatment.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have good organ function based on specific medical tests.

Additional criteria for Parts 1 and 3:

  • Have an advanced solid tumor and have tried all standard treatments without success.

Additional criteria for Part 2:

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

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments.
  • Have taken a WRN inhibitor before.
  • Cannot swallow pills.
  • Have uncontrolled cancer spread to the brain or spinal fluid.
  • Have another cancer that has progressed or needed treatment in the last 2 years, except for certain skin cancers or low-risk cancers.
  • Have digestive issues that affect drug absorption.
  • Have severe liver damage or disease.
  • Are allergic to the study drugs or their ingredients.
  • Have WRN syndrome.
  • Have an active autoimmune disease needing treatment in the last 2 years.

Additional criteria for Part 3:

  • Have had severe side effects from previous immunotherapy, such as severe skin reactions, heart inflammation, or lung disease.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site80218DenverColorado

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