This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Dose-limiting toxicities (DLTs)
Number of participants with DLTs
Time frame: Up to 3 weeks
Recommended phase II dose
The Recommended phase II dose of SHR-7367 injection
Time frame: first dose of study medication up to 21 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to 12 months
Tumor response using RECIST 1.1
Time frame: From first dose to disease progression or death, whichever comes first, up to 12 months
peak time (Tmax)
Time frame: Up to 12 months
peak concentration (Cmax)
Time frame: Up to 12 months
area under curve from 0 to the last measurable concentration time point t (AUC0-t),
Time frame: Up to 12 months
area under curve from 0 to infinity (AUC0-∞)
Time frame: Up to 12 months
elimination half-life (t1/2)
Time frame: Up to 12 months
clearance rate (CL)
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
steady-state apparent volume of distribution (Vss)
Time frame: Up to 12 months
steady-state peak concentration (Cmax, ss)
Time frame: Up to 12 months
steady-state valley concentration (Ctrough, ss)
Time frame: Up to 12 months
accumulation ratio (Rac)
Time frame: Up to 12 months
percentage of activated B lymphocyte subsets in peripheral blood
Time frame: Up to 12 months
Immunogenicity index: drug-resistant antibody (ADA)
Time frame: Up to 12 months
Efficacy endpoints: Objective response rate (ORR)
Time frame: Up to 12 months