This study is a prospective, single-arm, open-label, dose-escalation study. A total of 5 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC516
Time frame: 42 days after first dose
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of FC516
Time frame: Approximately 12 months
Determine the Maximum Tolerated Dose (MTD)
Determine the MTD of FC516
Time frame: Approximately 12 months
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Time frame: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Time frame: Approximately 12 months
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Time frame: Approximately 12 months
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