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Olverembatinib

Phase 3

GIST | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Dec 23, 2025

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical trial landscape

Olverembatinib · 4 trials · 7 indications

Phase 3 3Phase 1 1
NCT06423911Study of Olverembatinib (HQP1351) in Patients With CP-CMLChronic Myeloid Leukemia
RECRUITING285 Analytics
NCT06051409A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.Ph+ ALL
RECRUITING350 Analytics
NCT06640361A Study of Olverembatinib in SDH-deficient GIST.GIST
RECRUITING40 Analytics
PHASE3RECRUITING
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Chronic Myeloid LeukemiaUnlock trial analytics
PHASE3RECRUITING
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
Ph+ ALLUnlock trial analytics
PHASE3RECRUITING
A Study of Olverembatinib in SDH-deficient GIST.
GISTUnlock trial analytics
Study Endpoints
Primary Endpoints
Progression-free survival(PFS) rate
36 months

Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.

Secondary Endpoints
Plasma concentrations of olverembatinib
Cycle 2 to Cycle 3 (each cycle is 28 days)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Through study completion,an average of 2 years.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OlverembatinibEXPERIMENTAL -
Interventions
NameTypeDescription
olverembatinibDRUGolverembatinib QOD
BosutinibDRUGBosutnib QD
ImatinibDRUGOrally, once daily (QD).
Olverembatinib 20mgDRUGorally after meal, single dose
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Eligibility Criteria
Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator. 2. Must have at least one measurable target ...

Countries:United StatesAustraliaChina
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06640361primaryCompletionDate: changed
LOWMay 24, 2026NCT06423911studyFirstPostDate: changed
LOWMay 24, 2026NCT07282093studyFirstPostDate: changed
LOWMay 24, 2026NCT06640361studyFirstPostDate: changed
LOWMay 24, 2026NCT06051409studyFirstPostDate: changed