drugset / Trial / NCT07218926

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

NCT07218926

Phase 3 Recruiting 450 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-03
Primary completion
2028-05-30
Completion
2030-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject IDRX-42 Small molecule
Comparator Sunitinib Small molecule