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DCC-2618

Phase 2

Gastrointestinal Stromal Tumors | Small molecule | Oncology |Zai Lab Limited|Last Updated: Mar 3, 2025

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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04282980A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)PHASE2 COMPLETED 39Apr 23, 2020Aug 23, 2022Mar 3, 20259 China
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS)
Approximately 10 months since the first subject enrolled.

Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).

Secondary Endpoints
Objective Response Rate (ORR)
Approximately 15 months since the first subject enrolled.
Overall Survival (OS)
Approximately 28 months since the first subject enrolled.
Time to Best Response (TBR)
Approximately 15 months since the first subject enrolled.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DCC-2618EXPERIMENTALDCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
Interventions
NameTypeDescription
DCC-2618DRUGOral kinase inhibitor
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female patients ≥18 years of age. * Patients with advanced gastrointestinal stromal tumors. * Subjects who have progressed or documented intolerance after previous treatments. * Sign informed consent, understand the Protocol and could follow the Protocol. * The subject...

Countries:China
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