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YS-0N-001

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

YS-0N-001 · 1 trial · 1 indication

Phase 1 1
NCT03131765Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid TumorsCancer
COMPLETED31 Analytics
PHASE1COMPLETED
Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors
CancerUnlock trial analytics

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 to 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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Frequently asked questions about YS-0N-001

What is YS-0N-001 used for?

YS-0N-001 is an investigational monoclonal antibody being developed for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in patients with advanced solid tumors to evaluate its safety and tolerability.

Who makes YS-0N-001?

YS-0N-001 is being developed by LakeShore Biopharma Co., Ltd, a company listed on the stock exchange under the ticker symbol LSB. The company is conducting clinical research to evaluate the drug's potential as a cancer treatment.

What phase is YS-0N-001 in?

YS-0N-001 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and dosing in patients with advanced solid tumors. The drug is investigational and has not yet received regulatory approval for any indication.

What clinical trials is YS-0N-001 in?

YS-0N-001 has been studied in a Phase 1 clinical trial registered as NCT03131765, titled "Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors." This trial, which enrolled 31 participants in Singapore, has been completed.

Is YS-0N-001 the same as YS-ON-001?

Yes, YS-0N-001 and YS-ON-001 refer to the same investigational drug. The clinical trial NCT03131765 uses the name YS-ON-001 in its title, while the drug is also referred to as YS-0N-001 in other contexts. Both names denote the same monoclonal antibody being developed for cancer.