A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07218926

This study evaluates the efficacy and safety of IDRX-42 in adults with metastatic or unresectable GIST post-imatinib therapy. Eligible participants must have confirmed GIST with disease progression or imatinib intolerance. Tumor tissue is required for biomarker analysis. Participants will receive either IDRX-42 or sunitinib as part of the intervention.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.

Eligibility Criteria

Inclusion Criteria

  • Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
  • Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
  • Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

Exclusion Criteria

  • Known untreated or active central nervous system metastases.
  • Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site68130OmahaNebraska
GSK Investigational Site77030HoustonTexas
GSK Investigational Site98405TacomaWashington

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