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Clinical Trials in Canada / NCT07218926
Recruiting Phase 3

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

NCT07218926 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-12-03
Last updated
2026-09-25

Condition(s) studied

Gastrointestinal Neoplasms

Investigational drug(s) / intervention(s)

IDRX-42 →Sunitinib →

IDRX-42: IDRX-42 will be administered.

Sunitinib: Sunitinib will be administered.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (155)

FacilityCityRegionStatus
GSK Investigational Site Phoenix Arizona Recruiting
GSK Investigational Site Duarte California Recruiting
GSK Investigational Site La Jolla California Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site San Francisco California Recruiting
GSK Investigational Site Santa Monica California Recruiting
GSK Investigational Site Upland California Recruiting
GSK Investigational Site Aurora Colorado Recruiting
GSK Investigational Site New Haven Connecticut Recruiting
GSK Investigational Site Washington D.C. District of Columbia Recruiting
GSK Investigational Site Jacksonville Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Orlando Florida Recruiting
GSK Investigational Site Tampa Florida Recruiting
GSK Investigational Site Chicago Illinois Recruiting
GSK Investigational Site Chicago Illinois Recruiting
GSK Investigational Site Iowa City Iowa Recruiting
GSK Investigational Site Overland Park Kansas Recruiting
GSK Investigational Site Baton Rouge Louisiana Recruiting
GSK Investigational Site Baltimore Maryland Recruiting
GSK Investigational Site Boston Massachusetts Recruiting
GSK Investigational Site Boston Massachusetts Recruiting
GSK Investigational Site Ann Arbor Michigan Recruiting
GSK Investigational Site Rochester Minnesota Recruiting
GSK Investigational Site St Louis Missouri Recruiting
GSK Investigational Site Omaha Nebraska Recruiting
GSK Investigational Site New Hyde Park New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site Rochester New York Recruiting
GSK Investigational Site Charlotte North Carolina Recruiting
GSK Investigational Site Durham North Carolina Recruiting
GSK Investigational Site Canton Ohio Recruiting
GSK Investigational Site Columbus Ohio Recruiting
GSK Investigational Site Portland Oregon Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site Pittsburgh Pennsylvania Recruiting
GSK Investigational Site Spartanburg South Carolina Recruiting
GSK Investigational Site Knoxville Tennessee Recruiting

+ 115 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218926 on ClinicalTrials.gov ↗ ← All trials in Canada