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YS-0N-001

Phase 1

Cancer | Monoclonal antibody | Oncology |LakeShore Biopharma Co., Ltd|Last Updated: Dec 5, 2023

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03131765Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 31Apr 20, 2017Dec 16, 2019Dec 5, 20231 Singapore
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Study Endpoints
Primary Endpoints
Safety of YS-ON-001 by monitoring any adverse events (AE) and serious adverse events (SAE)
through study completion, an average of 1 year

To assess the safety of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors based on the identification of any adverse events through study completion

Tolerability of YS-ON-001 by recording AE /SAE, clinically significant changes in lab parameters and performance status (ECOG)
6 months

To assess the tolerability of YS-ON-001 in patients with advanced (metastatic and/or unresectable) solid tumors for recommended phase II dose (RP2D)

Dose-limiting toxicities (DLT)
For 4 weeks for DLTs

Number of Participants with a Dose Limiting Toxicity (DLT)

Secondary Endpoints
Antitumor Activity of YS-ON-001 by imaging measurement and assessing using RECIST Version 1.1
At 2 months, 4 months., 6months, 9 months and 1 year
Immunogenicity of YS-ON-001 evaluated by measuring serum titre level antibody against YS-ON-001
At 3 months, 6 months, 9 months and 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
YS-ON-001EXPERIMENTALPhase 1- Dose escalation based on YS-ON-001 safety and tolerability obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur. Phase 1b- recommended dose determined in Phase 1. Enrollment of two expansion cohorts will be restricted to the tumour types, breast cancer and liver cancer
Interventions
NameTypeDescription
YS-0N-001BIOLOGICALCancer vaccine
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Life expectancy ≥ 3 months * Patient with histologically or cytologically proven advanced (unresectable) or metastatic solid tumor who have failed standard therapies or are intolerant to standard therapies.Part 1: Any advanced or metastatic solid tumor patient Part 2: Selected...

Countries:Singapore
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