This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening/baseline and prior to dosing at subsequent visits.
Dose limiting toxicity (DLT)
Time frame: From Day 1 to Day 21
Frequency and severity of AE
Time frame: From Day 1 to 30 days after last dose.
Maximal tolerable dose (MTD)
Time frame: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Time frame: From Day 1 to 12 months.
ORR
Time frame: From Day 1 to 12 months.
Cmax
Time frame: From Day 1 to 12 months.
AUCss,
Time frame: From Day 1 to 12 months.
ORR
Time frame: From Day 1 to 12 months.
PFS
Time frame: From Day 1 to 12 months.
OS
Time frame: From Day 1 to 18 months.
Positive rate for ADA
Time frame: From Day 1 to 18 months.
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