Study on the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, for Advanced Gastrointestinal Cancers That Cannot Be Surgically Removed

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT06885034

This clinical trial is testing a new medicine, GSK5764227, to see how well it works and how safe it is for people with advanced gastrointestinal cancers that cannot be removed by surgery. The study includes participants from around the world who have already received treatment for their cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new drug, GSK5764227, in people with advanced gastrointestinal cancers that cannot be surgically removed. Researchers will also study how the body processes this drug. Participants in this study have previously received treatment for their cancer, and the study will take place in various locations worldwide.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old or the legal age of consent in the study location.

CRC Cohort:

  • Have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
  • Have received 1 to 2 previous treatments for advanced colorectal cancer, with cancer progression documented.
  • Provide a tumor sample from a recent biopsy or an archived sample.

PDAC Cohort:

  • Have a confirmed diagnosis of advanced pancreatic cancer that cannot be surgically removed.
  • Have received 1 previous treatment for advanced pancreatic cancer, with cancer progression documented.
  • Provide a tumor sample at screening, if possible.

All Cohorts:

  • Have at least one measurable tumor.
  • Agree to use effective contraception.
  • Be able to give informed consent and follow study requirements.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function.

Exclusion Criteria

  • Have another cancer that has progressed or required treatment in the past 24 months, except for certain skin or in-situ cancers that have been removed.
  • Have had major surgery within 28 days before starting the study.
  • Have had a bone marrow or organ transplant.
  • Have allergies to the study drug or its components.
  • Have severe or uncontrolled heart problems.
  • Have poorly controlled high blood pressure.
  • Have significant bleeding issues within 1 month before starting the study.
  • Have a serious infection within 4 weeks before starting the study.
  • Have active infections requiring treatment or known HIV.
  • Have had serious blood clots within 3 months before starting the study.
  • Have untreated or progressing brain or CNS cancer.
  • Have current or past lung inflammation requiring treatment within 90 days before starting the study.
  • Have a history of autoimmune disease requiring treatment in the past 2 years.
  • Have active kidney problems.
  • Have unresolved side effects from previous treatments.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have liver disease or cirrhosis.
  • Have active hepatitis B or C infections.
  • Have used immunosuppressive drugs within 30 days before starting the study.
  • Have received a specific type of cancer therapy before.
  • Have received a live vaccine within 30 days before starting the study.
  • Are participating in another clinical trial or have received other treatments within 4 weeks before starting the study.
  • Are pregnant or breastfeeding.
  • Cannot follow the study's schedule and requirements.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site90720Los AlamitosCalifornia
GSK Investigational Site90602WhittierCalifornia
GSK Investigational Site10065New YorkNew York
GSK Investigational Site27710DurhamNorth Carolina
GSK Investigational Site77479HoustonTexas
GSK Investigational Site78229San AntonioTexas
GSK Investigational Site98801WenatcheeWashington

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