Status:
RECRUITING
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2030
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07218926
Start Date
December 3 2025
End Date
November 29 2030
Last Update
January 8 2026
Active Locations (14)
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1
GSK Investigational Site
Boston, Massachusetts, United States, 02215
2
GSK Investigational Site
Omaha, Nebraska, United States, 68130
3
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
4
GSK Investigational Site
Houston, Texas, United States, 77030