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HC-1119

Phase 1

Metastatic Castration Resistant Prostate Cancer | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Nov 3, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03774056A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.PHASE1 COMPLETED 43 — — Feb 10, 2017Aug 28, 2019Nov 3, 20201 China
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Study Endpoints
Primary Endpoints
Dose-limiting toxicities(DLT)
From the first dose of the study to the 12th week after dose

Safety measures

Number of patients with adverse events
From the first dose of the study to the 12th week after dose

Safety measures

Secondary Endpoints
Maximum drug concentration(Cmax)
From the first dose of the study to the 12th week after dose
Time of maximum drug concentration(Tmax)
From the first dose of the study to the 12th week after dose
Area under curve from time 0 to 24h (AUC0-24h)
From the first dose of the study to the 12th week after dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
dose groupEXPERIMENTALDrug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg
Interventions
NameTypeDescription
HC-1119DRUGoral
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria (those who meet all of the following are eligible): 1. Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form; 2. Male , ≥18 years old; 3. With histologically or cytologically confirmed prostate cancer, without neur...

Countries:China
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