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

September 4, 2026 updated by: GlaxoSmithKline

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eiji Oki
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshito Komatsu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Velzatinib
Drug: Velzatinib
Velzatinib will be administered.
Other Names:
  • GSK6042981

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed objective response rate (ORR)
Time Frame: Up to 67 weeks
ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).
Up to 67 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: Up to 156 weeks
DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented disease progression (PD) or death due to any cause, whichever comes first.
Up to 156 weeks
Disease control rate for minimum 8-week period (DCR8)
Time Frame: Up to 156 weeks
DCR8 is defined as the percent of participants reaching confirmed CR or PR, or stable disease (SD) sustained for a minimum period of 8 weeks.
Up to 156 weeks
Progression free survival (PFS)
Time Frame: Up to 156 weeks
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death due to any cause, whichever comes first.
Up to 156 weeks
Overall survival (OS)
Time Frame: Up to 156 weeks
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
Up to 156 weeks
Confirmed ORR
Time Frame: Up to 156 weeks
ORR is defined as the percent of participants reaching confirmed CR or PR.
Up to 156 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17)
Time Frame: Baseline (Day 1) up to 156 weeks
The EORTC QLQ-F17 is a shorter version of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Scores for each scale are averaged and transformed linearly to a score ranging from 0-100. A high score for functional scales and for Global Health Status/QoL represents better functioning ability or HRQoL.
Baseline (Day 1) up to 156 weeks
Change from baseline in EQ-5D-5L score
Time Frame: Baseline (Day 1) up to 156 weeks
The EQ-5D-5L is a validated standardised, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Baseline (Day 1) up to 156 weeks
Plasma concentrations of velzatinib
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), dose reductions and interruptions and discontinuation of study treatment due to toxicity by severity
Time Frame: Up to 156 weeks
Up to 156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2026

Primary Completion (Estimated)

November 29, 2027

Study Completion (Estimated)

August 17, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 309344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe