This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.
This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
QLF3108 will be administered independent of body weight.
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
RECRUITINGDLTs of QLF3108
dose-limiting toxicity
Time frame: Approximately 24 months
MTD(s) of QLF3108
the maximum tolerated dose
Time frame: Approximately 24 months
RP2D of QLF3108
a recommended Phase 2 dose
Time frame: Approximately 24 months
The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
Time frame: Approximately 24 month
The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
Time frame: Approximately 24 month
Cmax of QLF3108
Pharmacokinetics of QLF3108 by assessment of maximum plasma QLF3108 concentration.
Time frame: Approximately 24 month
Tmax of QLF3108
Pharmacokinetics of QLF3108 by assessment of time to Cmax
Time frame: Approximately 24 month
Area under the plasma concentration-time curve (AUC) of QLF3108
Pharmacokinetics of QLF3108 by assessment of area under the plasma concentration time curve from zero to infinity
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Time frame: Approximately 24 month
Tl/2 of QLF3108
Pharmacokinetics of QLF3108 by assessment of the terminal half-life
Time frame: Approximately 24 month
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Approximately 24 months
Duration of Response (DOR)
DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Approximately 24 months
Progression-free survival (PFS)
PFS defined as the time from baseline to first observed disease progression or death from any cause
Time frame: Approximately 24 months
Overall survival time (OS)
Overall survival (OS) is the time between the subject's first infusion QLF3108 injection and death from any cause.
Time frame: Approximately 24 months