Clinical Trial

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

Recruiting Phase 3
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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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.
Protocol Amendment History 3 changes
notable Trial sites expanded: 121 -> 124 locations 2026-06-13
notable Trial sites expanded: 84 -> 121 locations 2026-05-28
notable Trial sites expanded: 20 -> 84 locations 2026-04-04
Trial Details
NCT Number NCT07218926
Lead Sponsor GlaxoSmithKline
Conditions Gastrointestinal Neoplasms
Enrollment 450 participants
Start Date 2025-12-03
Primary Completion 2028-05-30 (estimated)
Study Completion 2030-11-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-12