Clinical Study of JS201 in Patients With Advanced Malignant Tumors
- Registration Number
- NCT04956926
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JS201 JS201 -
- Primary Outcome Measures
Name Time Method Number of Subjects with serious adverse event (SAE) Up to 2 years 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
Number of Subjects with immune related adverse event (irAE) Up to 2 years IrAE is assessed according to the judgement of investigators
Number of Subjects with adverse event (AE) Up to 2 years 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.
Number of subjects with DLT (Dose limiting Toxicity) 21 days after first infusion of study drug 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);
- Secondary Outcome Measures
Name Time Method volume of distribution (Vss) Up to 2 years Vss after JS201 administration
anti-drug body (ADA) Up to 2 years incidence of anti-drug body (ADA)
peak concentration (Cmax) Up to 2 years Cmax after JS201 administration
elimination half-life (t1/2) Up to 2 years t1/2 after JS201 administration
OS Up to 2 years OS is defined as the time from the date of randomization to the date of death due to any cause.
trough concentration (Ctrough) Up to 2 years Ctrough after JS201 administration
area under the plasma drug concentration-time curve (AUC0-t ) Up to 2 years AUC0-t after JS201 administration
clearance rate (CL) Up to 2 years CL after JS201 administration
ORR Up to 2 years 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 Up to 2 years 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.
DCR Up to 2 years 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 Up to 2 years 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.
Trial Locations
- Locations (18)
Beiijng Cancer Hospital
🇨🇳Beijin, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangong, China
Harbin medical University cancer hospital
🇨🇳Harbin, Heilongjiang, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhenzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Techonoly
🇨🇳Wuhan, Hubei, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Shandong Tumor Hospital
🇨🇳Jinan, Shandong, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Cancer Hospital of the University of Chinese Academy of Sciences
🇨🇳Hangzhou, Zhejiang, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China