A Study Explore JS001+JS002 in Patients With Advanced Cancer

Phase 1

Terminated

• Conditions: Advanced Cancer
• Interventions: Drug: JS001(Toripalimab)+JS002

• Registration Number: NCT05128539
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

This open-label phase I clinical study with clinical development phase will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS002 combined with Toripalimab in advanced cancer patients, who has failed standard therapy OR could not tolerate standard therapy OR refused/had no standard therapy.

This study is divided into two parts:

Part A. JS002 combined with Toripalimab dose escalation and dose expansion phase; Part B.JS002 combined with Toripalimab clinical expansion phase.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-22
• Study Start: 2022-02-10
• Primary Completion: 2023-11-10
• Study Completion: 2023-11-10
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS001(Toripalimab)+JS002	JS001(Toripalimab)+JS002	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLTs)	3 years	Safety endpoints
adverse events (AE)、SAE、irAE	3 years	Safety endpoints: adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE);
MTD	1 year	Maximum tolerated dose (MTD)
Recommended dose for extension (RDE)	1 year	Recommended dose for extension (RDE)

Secondary Outcome Measures

Name	Time	Method
DCR	2 years	Efficacy endpoints: Disease control rate (DCR) based on RECIST 1.1 criteria
TTR	2 years	Efficacy endpoints:Time to response (TTR) based on RECIST 1.1 criteria
PFS	2 years	Efficacy endpoints:progression-free survival (PFS) based on RECIST 1.1 criteria
DOR	2 years	Efficacy endpoints: Uration of response (DOR) based on RECIST 1.1 criteria
ORR	2 years	Efficacy endpoints: Objective response rate (ORR) based on RECIST 1.1 criteria
Peak concentration（Cmax）	2 years	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) :peak concentration (Cmax) ;
Peak time（Tmax）	2 year	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) ：peak time (Tmax) ;
Elimination half-life (T1/2)	2 years	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) ：elimination half-life (T1/2)
OS	2 years	Efficacy endpoints:overall survival (OS) based on RECIST 1.1 criteria
1-year OS rate	1 year	Efficacy endpoints: 1-year OS rate based on RECIST 1.1 criteria
Pharmacokinetic (PK) characteristics	2 years	Drug concentration of individual subjects at different time points after administration;
Clearance rate (CL)	2 years	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) ：clearance rate (CL) ;
Volume of distribution (Vss)	2 years	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) ：volume of distribution (Vss)
Area under blood concentration-time curve (AUC0-T and AUC0-)	2 years	The pharmacokinetic parameters of JS002 and Toripalimab (JS001) :area under blood concentration-time curve (AUC0-T and AUC0-) ;
ADA against	2 years	Incidences of ADA against JS002 and Toripalimab (JS001), respectively

Trial Locations

Locations (1)

Henan Tumor Hospital; 🇨🇳 Zhengzhou, Henan, China