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 HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle
Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle
Oncology Physicians Network (OPN) - Glendale
Glendale, California, United States
RECRUITINGOncology Physicians Network (OPN)- Los Alamitos
Los Alamitos, California, United States
RECRUITINGHCA
Los Angeles, California, United States
NOT_YET_RECRUITINGLos Angeles Cancer Network
Los Angeles, California, United States
AUC0-21d
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose
Time frame: rom time 0 to 21 days after the 1st dose (3 weeks)
AUCss
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 6th dose
Time frame: from time 0 to 21 days after the 6th dose (18 weeks)
maximum serum drug concentration (Cmax),
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: up to 24 weeks
trough serum drug concentration at steady state (Ctrough,ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: up to 24 weeks
maximum serum drug concentration at steady state (Cmax,ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: up to 24 weeks
trough serum drug concentration (Ctrough)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: up to 24 weeks
DFS
Defined as the time from randomization to tumor recurrence, the development of new tumor lesions, or death due to any reasons (whichever occur first).
Time frame: up to 12 months
Adverse events
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
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Number of participants with abnormal physical examination findings
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Number of participants with abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Number of participants with abnormal 12-lead ECG readings
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Immunogenicity endpoint
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb)
Time frame: up to 24 weeks
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Oncology Physicians Network (OPN) - San Bernardino
San Bernardino, California, United States
RECRUITINGBRCR Global
Deerfield Beach, Florida, United States
NOT_YET_RECRUITINGD&H National Research Center
Margate, Florida, United States
RECRUITINGOcala Oncology
Ocala, Florida, United States
NOT_YET_RECRUITINGMid Florida Hematology and oncology Center
Orange City, Florida, United States
RECRUITINGOncology Consulatants (P1 Trials -Exigent Network)
Houston, Texas, United States
NOT_YET_RECRUITING...and 59 more locations