An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors
Overview
- Phase
- Phase 1
- Intervention
- JS201
- Conditions
- Patients With Advanced Malignant Tumors
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 244
- Locations
- 18
- Primary Endpoint
- Number of Subjects with serious adverse event (SAE)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
JS201
Intervention: JS201
Outcomes
Primary Outcomes
Number of Subjects with serious adverse event (SAE)
Time Frame: 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)
Time Frame: Up to 2 years
IrAE is assessed according to the judgement of investigators
Number of Subjects with adverse event (AE)
Time Frame: 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)
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);
Secondary Outcomes
- elimination half-life (t1/2)(Up to 2 years)
- OS(Up to 2 years)
- trough concentration (Ctrough)(Up to 2 years)
- area under the plasma drug concentration-time curve (AUC0-t )(Up to 2 years)
- volume of distribution (Vss)(Up to 2 years)
- clearance rate (CL)(Up to 2 years)
- ORR(Up to 2 years)
- DOR(Up to 2 years)
- anti-drug body (ADA)(Up to 2 years)
- peak concentration (Cmax)(Up to 2 years)
- DCR(Up to 2 years)
- PFS(Up to 2 years)