This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Dose limiting toxicity
Time frame: Days 1-21
Percentage of patients with adverse events
Time frame: from the first drug administration to within 90 days for the last SHR-1802 dose
Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events
Time frame: At pre-defined intervals from initial dose up to 24 months
ORR
Time frame: At pre-defined intervals from initial dose up to 24 months
DOR
Time frame: At pre-defined intervals from initial dose up to 24 months
DCR
Time frame: At pre-defined intervals from initial dose up to 24 months
PFS
Time frame: At pre-defined intervals from initial dose up to 24 months
Maximum Concentration (Cmax) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Time of Maximum Concentration (Tmax) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Area Under the Curve (AUC) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
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Terminal Half-Life (T1/2) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Clearance (CL) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Volume of Distribution at Steady State (Vss) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Evaluation of the immunogenicity of SHR-1802
Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)