Recent Updates
Recently added Catalysts

CS3007

Phase 1

Gastrointestinal Stromal Tumors | Small molecule | Oncology |Blueprint Medicines Corporation|Last Updated: Apr 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04254939A Study of CS3007 in Subjects With Gastrointestinal Stromal TumorPHASE1 COMPLETED 65 — — Aug 15, 2019Apr 11, 2023Apr 27, 202316 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings
at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures
Phase II: ORR based on mRESIST 1.1
At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CS3007(BLU-285)EXPERIMENTAL -
Interventions
NameTypeDescription
CS3007 (BLU-285)DRUGA modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: 1. For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene...

Countries:China
Unlock Eligibility Criteria