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Adebrelimab

Phase 1

Advanced Hepatocellular Carcinoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jun 21, 2024

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05444088Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular CarcinomaPHASE1 RECRUITING 129 — — Aug 2, 2022Jun 30, 2026Jun 21, 20241 China
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity
The observation period is 21 days after the first dose
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Objective Response Rate
At the time point of every 6 or 9 weeks, up to 2 years

determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

Secondary Endpoints
Disease Control Rate, determined using RECIST v1.1 criteria
At the time point of every 6 or 9 weeks, up to 2 years
Progression-Free-Survival assessed by investigator
up to 2 years]
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Adebrelimab in combination with BevacizumabEXPERIMENTAL -
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1EXPERIMENTAL -
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2EXPERIMENTAL -
Interventions
NameTypeDescription
AdebrelimabDRUGintravenous infusion
BevacizumabDRUGintravenous infusion
SHR-8068DRUGintravenous infusion
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18\~75 years old, both male and female; 2. Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment; 3. Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have...

Countries:China
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