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

NCT07689201 | Recruiting Phase 2

• 1 other identifier: 309344
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gastrointestinal Neoplasms

Keywords

Velzatinib; GSK6042981; IDRX-42; Gastrointestinal Stromal Tumors (GIST)

Outcome Measures

Primary Outcomes (1)

• Confirmed objective response rate (ORR)

  ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).

  Up to 67 weeks

Secondary Outcomes (9)

• Duration of response (DOR)

  Up to 156 weeks

• Disease control rate for minimum 8-week period (DCR8)

  Up to 156 weeks

• Progression free survival (PFS)

  Up to 156 weeks

• Overall survival (OS)

  Up to 156 weeks

• Confirmed ORR

  Up to 156 weeks

Study Arms (1)

Velzatinib

EXPERIMENTAL

Drug: Velzatinib

Interventions

Velzatinib DRUG

Velzatinib will be administered.

Also known as: GSK6042981

Velzatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Investigators may consult with the sponsor regarding the enrolment of participants for whom archival tissue is no longer available and who are not eligible to undergo a new biopsy.
• Is willing to use adequate contraception male and/or female participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Fukuoka, 812-8582, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 060-8648, Japan

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): August 17, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)