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A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

Primary Investigator
Schuetze, Scott
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT07218926
UM Number
2025.122
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Connective Tissue Oncology
ID (Protocol)
58122
Secondary Protocol No
HUM00282371
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Soft Tissue
Summary
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: 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.