This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors. The study includes a dose-escalation phase, a dose-expansion phase, and an indication-expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
The administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W.
JILIN Cancer Hospital
Jilin City, China
RECRUITINGEvaluate the incidence of adverse events (AEs)
Time frame: Up to 3 years
Evaluate the incidence of serious adverse events (SAEs)
Time frame: Up to 3 years
Evaluate the incidence of treatment related adverse events (TRAEs)
Time frame: Up to 3 years
Evaluate the incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part
Investigate the antitumor activity of SKB500
Time frame: Up to 3 years
To evaluate the Tmax of SKB500
Time frame: Up to 3 years
To evaluate the Cmax of SKB500
Time frame: Up to 3 years
To evaluate the Cmin of SKB500
Time frame: Up to 3 years
To evaluate the AUC of SKB500
Time frame: Up to 3 years
To evaluate the t1/2 of SKB500
Time frame: Up to 3 years
To evaluate the CL of SKB500
Time frame: Up to 3 years
To evaluate the Vz of SKB500
Time frame: Up to 3 years
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To evaluate the ADA of SKB500
Time frame: Up to 3 years