This is a Phase 1, open label, first-in-human study to evaluate safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and anti-tumor activity of SHR-4712 in patients with advanced solid tumors. Patients will treat with SHR-4712 until unacceptable toxicity or disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
SHR-4712 injection.
Fujian Cancer Hospital
Fuzhou, Fujian, China
Hunan Cancer Hospital
Changsha, Hunan, China
Dose Limited Toxicity (DLT)
Time frame: First 21 days of treatment.
Adverse Events (AEs)
Time frame: Approximately 24 months.
Time to peak concentration (Tmax)
Time frame: Approximately 24 months.
Peak concentration (Cmax)
Time frame: Approximately 24 months.
Trough concentration (Ctrough)
Time frame: Approximately 24 months.
Area under the concentration-time curve from time zero to the last measurable time point (AUC0-t)
Time frame: Approximately 24 months.
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Approximately 24 months.
Elimination half-life (t1/2)
Time frame: Approximately 24 months.
Apparent clearance (CL/F)
Time frame: Approximately 24 months.
Apparent volume of distribution (Vz/F)
Time frame: Approximately 24 months.
Objective response rate (ORR)
Time frame: Approximately 24 months.
Duration of objective tumor response (DoR)
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Time frame: Approximately 24 months.
Disease control rate (DCR)
Time frame: Approximately 24 months.
Progression-free survival (PFS)
Time frame: Approximately 24 months.
Overall survival (OS)
Time frame: Approximately 24 months.