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SHR-8068

Phase 1

Colorectal Cancer | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Apr 18, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06373133SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal CancerPHASE1 NOT YET_RECRUITING 36May 1, 2024Nov 1, 2026Apr 18, 2024 -
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity
The first 21 days of the first cycle of medication

The dose is considered tolerable if the incidence of DLT is less than 33.3%.

PFS
Up to 2 years

Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR-8068+Adebrelimab+BP102EXPERIMENTALThe first 9 subjects will be treated with low dose SHR-8068 (1mg/kg, q6w), and the subsequent subjects will be treated with high dose SHR-8068 (4mg/kg, q12w) if the toxicity of DLT is tolerable during the observation period.
Interventions
NameTypeDescription
SHR-8068DRUG1mg/kg,ivgtt, d1, q6w or 4mg/kg,ivgtt, d1, q12w
AdebrelimabDRUG1200mg, ivgtt, d1, q3w
BP102DRUG7.5mg/kg, ivgtt, d1, q3w
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. pathologically confirmed metastatic colorectal adenocarcinoma; 2. Age of 18-75 years old, both sexes; 3. predicted survival time ≥12 weeks; 4. Eastern Cooperative Oncology Group performance status (ECOG) score 0-2; 5. Participants who had failed second-line or higher standard...

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Competitive Landscape -Colorectal Cancer 263 trials
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Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
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BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
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Veracyte, Inc.VCYT1PHASE3Tislelizumab
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