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

Open to people ages 18 years and up

• 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.

• 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.