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

Recruiting now · Phase 3

Conditions studied: Gastrointestinal Neoplasms

In brief

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.

Key facts

Study ID

NCT07218926

Run by

GlaxoSmithKline

People needed

450

Starts

2025-12-03

Expected to finish

2030-11-29

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.
• Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.

You may not qualify if…

• GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
• 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.

Where it is running

• GSK Investigational Site — La Jolla, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — San Francisco, California, United States (enrolling)
• GSK Investigational Site — New Haven, Connecticut, United States (enrolling)
• GSK Investigational Site — Jacksonville, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Orlando, Florida, United States (enrolling)
• GSK Investigational Site — Tampa, Florida, United States (enrolling)
• GSK Investigational Site — Iowa City, Iowa, United States (enrolling)
• GSK Investigational Site — Overland Park, Kansas, United States (enrolling)
• GSK Investigational Site — Boston, Massachusetts, United States (enrolling)
• GSK Investigational Site — Boston, Massachusetts, United States (enrolling)
• GSK Investigational Site — Ann Arbor, Michigan, United States (enrolling)
• GSK Investigational Site — Rochester, Minnesota, United States (enrolling)
• GSK Investigational Site — St Louis, Missouri, United States (enrolling)
• GSK Investigational Site — Omaha, Nebraska, United States (enrolling)
• GSK Investigational Site — Lake Success, New York, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — Rochester, New York, United States (enrolling)
• GSK Investigational Site — Durham, North Carolina, United States (enrolling)
• GSK Investigational Site — Columbus, Ohio, United States (enrolling)
• GSK Investigational Site — Portland, Oregon, United States (enrolling)
• GSK Investigational Site — Philadelphia, Pennsylvania, United States (enrolling)
• GSK Investigational Site — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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