JS201 is administered intravenously Q3W at the corresponding dose.

JS201

Pan He, Postgraduate

Ziping Wang, Prof

Ning Xu, Prof

Zhiming Li, Prof

Jundong Li, Prof

Xicheng Wang, Prof

Fangjian Zhou, Prof

Aimin Zang, Prof

Yanqiao Zhang, Prof

Yanqiu Zhao, Prof

Shujun Yang, Prof

Qingxia Fan, Prof

Guiling li, Prof

Hongjian Guo, Prof

Yong Mao, Prof

Yong Liu, Prof

Bin Hu, Prof

Bo Liu, Prof

Peng Zhang, Prof

Jiyan Liu, Prof

Yun Fan, Prof

Li Zhang, Prof

This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.

Clinical Study of JS201 in Patients With Advanced Malignant Tumors

An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors

DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0);

An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.

A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect

IrAE is assessed according to the judgement of investigators

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) or Lugano criteria (2014, lymphoma), including complete response (CR) and partial response (PR).

DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.

The efficacy evaluated by the investigator per RECIST 1.1 criteria (solid tumors) or Lugano criteria (2014, lymphoma), including CR, PR and stable disease (SD);

PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.

OS is defined as the time from the date of randomization to the date of death due to any cause.

Spots Global Cancer Trial Database for js201

Every month we try and update this database with for js201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for js201

Every month we try and update this database with for js201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for js201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.