A Study of Velzatinib in Participants With Metastatic and... | NCT07689201

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

NCT07689201

Sponsor

GlaxoSmithKline

Status

Not yet recruiting

Last Update Posted

Jul 8, 2026Actual

Enrollment

24Estimated

Phase

Phase 2

Conditions

Gastrointestinal Neoplasms

Interventions

Velzatinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2026Estimated

Primary Completion Date

Dec 13, 2027Estimated

Completion Date

Aug 31, 2029Estimated

First Submitted Date

Jul 1, 2026

First Submission Date that Met QC Criteria

Jul 1, 2026

First Posted Date

Jul 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Label	Type	Description	Intervention Names
Velzatinib	Experimental		Drug: Velzatinib

Name	Type	Description	Arm Group Labels	Other Names
Velzatinib	Drug	Velzatinib will be administered.	Velzatinib	GSK6042981

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Duration of response (DOR)	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
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

IPD Sharing Statement Module

Plan to Share IPD

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D046152	Gastrointestinal Stromal Tumors

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases