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JS207

Phase 2

Advanced Colorectal Cancer | Monoclonal antibody | Oncology |Co-Diagnostics, Inc.|Last Updated: Jun 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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06885385A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal CancerPHASE2 RECRUITING 60Apr 23, 2025Feb 13, 2027Jun 24, 20252 China
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity (DLT)
2 Years

Incidence and severity of DLT

Adverse event(AE)
2 Years

Adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance

RP3D
2 Years

Recommended dose for phase II trial

Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
2 years

Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

Secondary Endpoints
Progression free survival(PFS)
2 years
Overall survival (OS)
2 years
Immunogenicity
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JS207EXPERIMENTAL -
Interventions
NameTypeDescription
JS207BIOLOGICALJS207 will be administered every 3 weeks for a treatment cycle of 21 days
JS015BIOLOGICALJS015 will be administered every 3 weeks for a treatment cycle of 21 days
CapecitabineDRUGCapecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle
OxaliplatinDRUGOxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female 2. Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage ...

Countries:China
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Competitive Landscape -Colorectal Cancer 263 trials
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Veracyte, Inc.VCYT1PHASE3Tislelizumab
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