A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib

A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)

The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.

Inclusion Criteria:

• Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
• Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
• Documented mutation status of KIT and/or PDGFRA.
• Tumor tissue must be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy.
• Is willing to use adequate contraception male and/or female participants.

Exclusion Criteria:

• Known untreated or active central nervous system metastases.
• Has significant, uncontrolled, or active cardiovascular disease.
• Participants with a known allergy or hypersensitivity to any component of velzatinib. 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.
• Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
• Is pregnant or breastfeeding.
• Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.