This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
YL201 will be administered as IV infusion
Ivonescimab will be administered as IV infusion.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence and severity of adverse events (AEs)
AEs are assessed based on NCI CTCAE v5.0.
Time frame: Approximately within 36 months
Maximum tolerate dose(MTD)
Time frame: Approximately within 36 months
Recommended Dose for Expansion
Time frame: Approximately within 36 months
Objective Response Rate (ORR)
ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
Time frame: Approximately within 36 months
Area Under the Concentration-time Curve (AUC)
Time frame: Approximately within 36 months
maximum concentration (Cmax)
Time frame: Approximately within 36 months
minimum concentration at trough (Ctrough)
Time frame: Approximately within 36 months
Volume of distribution (Vd)
Time frame: Approximately within 36 months
plasma clearance (CL)
Time frame: Approximately within 36 months
half-life (t1/2)
Time frame: Approximately within 36 months
Time to peak drug concentration (Tmax)
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Time frame: Approximately within 36 months
Investigator-assessed progression-free survival (PFS)
PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first
Time frame: Approximately within 36 months
Investigator-assessed overall survival (OS)
OS defined as the time interval from the first study drug administration to death due to any cause.
Time frame: Approximately within 36 months
Investigator-assessed disease control rate (DCR)
DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Time frame: Approximately within 36 months
Investigator-assessed time to response (TTR)
TTR defined as the time interval from the first study drug administration to the first documentation of response (CR or PR).
Time frame: Approximately within 36 months
Investigator-assessed the depth of response (DpR) per RECIST v1.1
The percentage change in target lesion size
Time frame: Approximately within 36 months
number of subjects who are Anti-Drug Antibody (ADA)-positive at any time
Time frame: Approximately within 36 months