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IBI308

Phase 2

Esophageal Squamous Cell Carcinoma | Monoclonal antibody | Oncology |Co-Diagnostics, Inc.|Last Updated: Feb 3, 2021

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03116152Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line TreatmentPHASE2 COMPLETED 190May 10, 2017Oct 2, 2019Feb 3, 20211 China
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Study Endpoints
Primary Endpoints
Overall Survival
Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

Secondary Endpoints
Progression-free Survival
Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)
Objective Response Rate
Through Final Analysis data cut-off date of 2-August-2019 (up to approximately 26 months)
Duration of Response
Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IBI308EXPERIMENTALIBI308 200mg Intravenous drip every three weeks
paclitaxel/irinotecanACTIVE_COMPARATORpaclitaxel 175mg/㎡ Intravenous drip every three weeks; irinotecan 180mg/㎡ Intravenous drip every two weeks
Interventions
NameTypeDescription
IBI308BIOLOGICALIBI308 200mg Intravenous drip every three weeks;
paclitaxel/ irinotecanDRUGpaclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma (excluding mixed adenosquamous carcinoma and other pathological types). 2. Imaging evidence (e.g. CT scan) or clinical evidence (e.g. cytological report of...

Countries:China
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