This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
SYS6010 by intravenous (IV)
Investigator's choice of monotherapy means the therapy chosen by investigators to treat HNSCC including docetaxel (35 mg/m\^2 by IV on Day 1、8、15, every 28 days),methotrexate(40 mg/m\^2 by IV on Day 1、8、15, every 21 days), paclitaxel (80 mg/m\^2 by IV on Day 1、8、15, every 28 days) or cetuximab(400 mg/m\^2 by IV on C1D1, followed by 250 mg/m\^2 weekly).
Objective Response Rate (ORR) as assessed by IRC per RECIST v.1.1.
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Time frame: Up to approximately 2 years
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) as assessed by investigators
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Time frame: Up to approximately 2 years
Kunyu Yang
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Incidence of adverse events assessed by CTCAE v6.0.
Time frame: Up to approximately 2 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to approximately 2 years
Plasma concentrations of toxin-bound antibodies
Tests are conducted after single and continuous administration of SYS6010.
Time frame: Up to approximately 2 years
Plasma concentrations of total antibodies
Tests are conducted after single and continuous administration of SYS6010.
Time frame: Up to approximately 2 years