Clinical Study of JS007 in Patients With Advanced Solid Tumors

Phase 1

• Conditions: Patients With Advanced Solid Tumors
• Interventions: Biological: JS007

• Registration Number: NCT05049265
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

This is an open label, phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS007 in the patients with advanced solid tumors who have progressed after standard of care, or lack of effective standard therapeutic regimen. This study is divided into two periods: dose escalation period, dose expansion period.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2021-11-17
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS007	JS007	-

Primary Outcome Measures

Name	Time	Method
MTD	Up to 12 approximately months	The maximum tolerated dose (MTD) is defined as the highest dose at which DLT （Dose-Limiting Toxicity）occurs in \<1/3 subjects
DLT	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)
Adverse Events	Up to 12 approximately months	AE is assessed according to NCI-CTCAE 5.0
Serious Adverse Events	Up to 12 approximately months	SAE（Serious adverse event） is assessed according to NCI-CTCAE 5.0
Incidence of immune-related adverse events (irAE)	Up to 12 approximately months	IrAE is assessed according to NCI-CTCAE 5.0
severity of immune-related adverse events (irAE)	Up to 12 approximately months	IrAE is assessed according to NCI-CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
peak concentration (Cmax)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);
trough concentration (Ctrough)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)
time to peak (Tmax)	Up to 18 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);
area under the plasma drug concentration-time curve (AUC0-t )	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t )
apparent volume of distribution(Vd)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; apparent volume of distribution(Vd)
volume of distribution (Vss)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)
mean retention time (MRT)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)
The number of lymphocyte in peripheral blood before and after administration	Up to 12 approximately months	The number of lymphocyte in peripheral blood before and after administration
The proportion of lymphocyte in peripheral blood before and after administration	Up to 12 approximately months	The proportion of lymphocyte in peripheral blood before and after administration
anti-drug body (ADA)	Up to 12 approximately months	incidence of anti-drug body (ADA)
neutralizing antibody (Nab)	Up to 12 approximately months	concentration of neutralizing antibody (Nab)
area under the plasma drug concentration-time curve (AUC0-inf)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);
elimination half-life (t1/2)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)
clearance rate (CL)	Up to 12 approximately months	Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medical; 🇨🇳 Shanghai, China