A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody (JS002) Combined With Toripalimab in Patients With Advanced Cancer
Overview
- Phase
- Phase 1
- Intervention
- JS001(Toripalimab)+JS002
- Conditions
- Advanced Cancer
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicities (DLTs)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
JS001(Toripalimab)+JS002
Intervention: JS001(Toripalimab)+JS002
Outcomes
Primary Outcomes
Dose-limiting toxicities (DLTs)
Time Frame: 3 years
Safety endpoints
adverse events (AE)、SAE、irAE
Time Frame: 3 years
Safety endpoints: adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE);
MTD
Time Frame: 1 year
Maximum tolerated dose (MTD)
Recommended dose for extension (RDE)
Time Frame: 1 year
Recommended dose for extension (RDE)
Secondary Outcomes
- DCR(2 years)
- TTR(2 years)
- DOR(2 years)
- PFS(2 years)
- ORR(2 years)
- Peak concentration（Cmax）(2 years)
- Peak time（Tmax）(2 year)
- Elimination half-life (T1/2)(2 years)
- OS(2 years)
- 1-year OS rate(1 year)
- Pharmacokinetic (PK) characteristics(2 years)
- Clearance rate (CL)(2 years)
- Volume of distribution (Vss)(2 years)
- Area under blood concentration-time curve (AUC0-T and AUC0-)(2 years)
- ADA against(2 years)