A Phase Ia Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single-dose and Multiple-dose Of JS007 Injection In Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients With Advanced Solid Tumors
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- MTD
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
MTD
Time Frame: 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
Time Frame: 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
Time Frame: Up to 12 approximately months
AE is assessed according to NCI-CTCAE 5.0
Serious Adverse Events
Time Frame: Up to 12 approximately months
SAE（Serious adverse event） is assessed according to NCI-CTCAE 5.0
Incidence of immune-related adverse events (irAE)
Time Frame: Up to 12 approximately months
IrAE is assessed according to NCI-CTCAE 5.0
severity of immune-related adverse events (irAE)
Time Frame: Up to 12 approximately months
IrAE is assessed according to NCI-CTCAE 5.0
Secondary Outcomes
- peak concentration (Cmax)(Up to 12 approximately months)
- trough concentration (Ctrough)(Up to 12 approximately months)
- time to peak (Tmax)(Up to 18 approximately months)
- area under the plasma drug concentration-time curve (AUC0-t )(Up to 12 approximately months)
- apparent volume of distribution(Vd)(Up to 12 approximately months)
- volume of distribution (Vss)(Up to 12 approximately months)
- mean retention time (MRT)(Up to 12 approximately months)
- The number 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(Up to 12 approximately months)
- anti-drug body (ADA)(Up to 12 approximately months)
- neutralizing antibody (Nab)(Up to 12 approximately months)
- area under the plasma drug concentration-time curve (AUC0-inf)(Up to 12 approximately months)
- elimination half-life (t1/2)(Up to 12 approximately months)
- clearance rate (CL)(Up to 12 approximately months)