This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
AUC0-28d
Time frame: From time 0 to 28 days after the 1st dose(4 weeks)
AUCss
Time frame: From time 0 to 28 days after the 4th dose(16 weeks)
maximum serum drug concentration (Cmax)
Time frame: up to 16 weeks
trough serum drug concentration (Ctrough)
Time frame: up to 16 weeks
maximum serum drug concentration at steady state (Cmax,ss)
Time frame: up to 16 weeks
trough serum drug concentration at steady state (Ctrough,ss)
Time frame: up to 16 weeks
Disease-free survival (DFS)
Time frame: up to 12 months
Adverse events (AEs); Serious adverse events (SAEs); Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions)
Time frame: From enrollment to the end of 90-day safety follow-up (up to 15 months)
Number of participants with abnormal vital signs, abnormal physical examination findings, abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers) or abnormal 12-lead ECG readings.
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb)
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Time frame: up to 24 weeks