Back to search results

A Study of IDRX-42 vs Sunitinib for GIST After Imatinib Therapy

This study is comparing a new drug, IDRX-42, to an existing drug, Sunitinib, for adults with Gastrointestinal Stromal Tumors (GIST). You may be eligible if your GIST has spread or cannot be removed by surgery, and has progressed after treatment with Imatinib. Researchers want to see if IDRX-42 is effective and safe. They will measure how long you live without your cancer getting worse (Progression-Free Survival) for up to about 130 weeks. Your tumor's genetic makeup, specifically mutations in KIT and/or PDGFRA, will be checked. The study plans to enroll 450 participants, but its current status is unclear.

Study design
This study is comparing two different drugs, IDRX-42 and Sunitinib, in about 450 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Progression-Free Survival, will be measured for up to approximately 130 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218926

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
GlaxoSmithKline
~450 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:IDRX-42Sunitinib

At a glance

Recruiting sites
124 of 124 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to approximately 130 weeks

Conditions

Gastrointestinal Neoplasms

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

124 sites across 48 states
Japan10
Spain9
France8
South Korea8
Italy7
United Kingdom7
Taiwan6
China5

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-Free Survival (PFS)Up to approximately 130 weeks

    PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.