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
Fujian Medical University Union Hospital
Fuzhou, China
RECRUITINGThe First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
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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The Second Hospital of Tianjin Medical University
Tianjin, China
RECRUITINGThe First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
RECRUITINGUnion Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, China
RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
RECRUITINGTime frame: up to 24 weeks