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OriC902

Phase 1

HCC | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Mar 24, 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 Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06891742Phase I Study of OriC902 in Treatment of Advanced HCCPHASE1 RECRUITING 44Feb 24, 2025Mar 31, 2028Mar 24, 20252 China
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Study Endpoints
Primary Endpoints
MTD or biologically effective dose
1year

SRC will select MTD or biologically effective dose

RP2D
1year

SRC will select RP2D based on safety, initial efficacy (if any) and PK data

Incidence and severity of AE and SAE,
2year

To evaluate the incidence and severity of AE and SAE

Secondary Endpoints
PK of OriC902
2year
Peripheral blood concentration of two antibodies(PD-L1&VEGF)
2year
Evaluate initial efficacy of OriC902
3year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OriC902EXPERIMENTALOriC902 injection, dosage is divided into 1E6/Kg, 3E6/ Kg, 6E6/Kg, 1E7/Kg
Interventions
NameTypeDescription
OriC902DRUGWhole peripheral blood mononuclear cells are extracted from patients (or donors) through leukocyte separation, and then the required T cell subsets are isolated, which will become the basis for the subsequent preparation of CAR T cells
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form (ICF) prior to conducting any assessment/procedure related to the study; 2. Ages 18 to 75 at the time of signing the ICF (including 18 and 75); 3. HCC was diagnosed according to the Primary Liver Cancer Diagnosis and Tr...

Countries:China
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