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Theliatinib

Phase 1

Cancer | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Feb 13, 2020

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02601248Study of Theliatinib (HMPL-309) in Patients With Advanced Solid TumorPHASE1 COMPLETED 24Oct 1, 2012May 1, 2016Feb 13, 20201 China
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Study Endpoints
Primary Endpoints
Safety :the incidence of all adverse events by type and grade, abnormal laboratory changes
from day 1 of first dosing to 30days after permanent discontinuation of Thialitinib

for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation

Secondary Endpoints
Area under the plasma concentration versus time curve (AUC)
Day 1-3 Single Dose and Day 1-28 Steady State
Peak Plasma Concentration (Cmax)
Day 1-3 Single Dose and Day 1-28 Steady State
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TheliatinibEXPERIMENTALTheliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 5 dose cohorts,including120mg/160mg/200mg/220mg/300mg, QD in the dose escalation stage .
Interventions
NameTypeDescription
TheliatinibDRUGTheliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histopathology confirmed solid tumors * Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions) * Age 18-75 * Performance status of 0, or 1, and no worse within 7days * Life expec...

Countries:China
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