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

GlaxoSmithKline (GSK)

Status and phase

Enrolling

Phase 3

Conditions

Gastrointestinal Neoplasms

Treatments

Drug: Sunitinib

Drug: IDRX-42

Study type

Interventional

Funder types

Industry

Identifiers

NCT07218926

2025-522229-37-00 (EU Trial (CTIS) Number)

300383

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

Exclusion criteria

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.