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Olverembatinib

Phase 3

GIST | Small molecule | Other |Ascentage Pharma Group International - American Depository Shares|Last Updated: Dec 27, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06640361A Study of Olverembatinib in SDH-deficient GIST.PHASE3 RECRUITING 40Nov 11, 2024Jun 30, 2029Dec 27, 20241 China
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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
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OlverembatinibEXPERIMENTAL -
Interventions
NameTypeDescription
OlverembatinibDRUGOral administration with meal, QOD, every 28 days for a cycle.
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Eligibility Criteria
Age Range12 Years — N/A
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:China
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06640361primaryCompletionDate: changed
LOWMay 24, 2026NCT06640361studyFirstPostDate: changed