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Velzatinib

Phase 3

Gastrointestinal Stromal Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

Velzatinib · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT07585266A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)Gastrointestinal Stromal Neoplasms
RECRUITING800 Analytics
PHASE3RECRUITING
A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
Gastrointestinal Stromal NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR)
Up to approximately 74 months

PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.

Confirmed objective response rate (ORR)
Up to 67 weeks

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

Secondary Endpoints

Confirmed Objective Response Rate (ORR) as assessed by BICR
Up to approximately 75 months
Overall survival (OS)
Up to approximately 75 months
Confirmed ORR as assessed by Investigator assessment
Up to approximately 75 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VelzatinibEXPERIMENTAL -
ImatinibEXPERIMENTAL -

Interventions

NameTypeDescription
VelzatinibDRUGVelzatinib will be administered
ImatinibDRUGImatinib will be administered
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF). * Has histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Has ...

Countries:United StatesArgentinaCanadaChinaJapanSouth KoreaTaiwan
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07585266Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07585266Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07585266Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07585266Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 8, 2026NCT07689201NEW_TRIAL: changed
LOWJul 8, 2026NCT07689201NEW_TRIAL: changed
LOWJul 7, 2026NCT07585266primaryCompletionDate: changed
LOWJul 7, 2026NCT07585266primaryCompletionDate: changed

Frequently asked questions about Velzatinib

What is Velzatinib used for?

Velzatinib is an investigational small molecule kinase inhibitor being studied for the treatment of gastrointestinal neoplasms, including gastrointestinal stromal tumors (GIST). It is being evaluated in patients with previously untreated metastatic and/or unresectable GIST, as well as in those whose disease has progressed after prior therapies.

Who makes Velzatinib?

Velzatinib is being developed by GSK plc, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol GSK.

What does Velzatinib target?

Velzatinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is designed to target specific kinases involved in tumor growth, though the exact molecular target has not been specified in available information.

What phase is Velzatinib in?

Velzatinib is currently in Phase 2 clinical development. It is being investigated in a Phase 2 study for patients with metastatic and/or unresectable gastrointestinal stromal tumors after prior treatment with imatinib, sunitinib, regorafenib, and pimitespib.

What clinical trials is Velzatinib in?

Velzatinib is being studied in two clinical trials. NCT07585266 is a Phase 3 study comparing Velzatinib with imatinib in previously untreated metastatic and/or unresectable GIST, currently recruiting 800 participants. NCT07689201 is a Phase 2 study in patients with GIST after prior therapies, not yet recruiting.

Is Velzatinib the same as imatinib?

No, Velzatinib is not the same as imatinib. Velzatinib is an investigational drug being compared with imatinib in a clinical trial for previously untreated gastrointestinal stromal tumors. Imatinib is an established standard treatment for this condition.