NCT07218926

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DRUG	IDRX-42	IDRX-42 will be administered.
DRUG	Sunitinib	Sunitinib will be administered.

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-05-30
• Completion: 2030-11-29
• First posted: 2025-10-21
• Last updated: 2026-04-03

Locations

84 sites across 18 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study