This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
All participants receive SHR-1906 alone
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 8 months
AEs (Adverse Events)
Time frame: 30 days after last dose
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1916
Time frame: 30 days after last dose
Minimum observed plasma concentration (Cmin) of SHR-1916
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1916
Time frame: 30 days after last dose
Percentage of NK cell and CD8+ T cell by flow cytometry
Time frame: 30 days after last dose
Absolute count values of NK cell and CD8+ T cell by flow cytometry
Time frame: 30 days after last dose
Peripheral plasma concentration of sCD25
Time frame: 30 days after last dose
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Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum
Time frame: 30 days after last dose
ORR(Objective Response Rate)
Time frame: at the time point of every 9 weeks
DCR(Disease Control Rate)
Time frame: at the time point of every 9 weeks
DoR(Duration of Response)
Time frame: up to 2 years
PFS(Progression-Free-Survival)
Time frame: up to 2 years
12-month-survival Rate
Time frame: up to 2 years