The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.
This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor. The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile, immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGShangdong Cancer Hospital & Institute
Jinan, Shangdong, China
RECRUITINGLinyi Cancer Hospital
Linyi, Shangdong, China
NOT_YET_RECRUITINGSeverity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
Time frame: During the first 4 week treatment cycle
Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
Time frame: up to 24 months
Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
Time frame: up to 24 months
Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
Time frame: up to 24 months
Severity (as graded by CTCAE v5.0) of adverse events assessed
Time frame: up to 24 months
Maximum plasma concentration (Cmax) of FP002
Time frame: up to 24 months
Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002
Time frame: up to 24 months
Area under the curve extrapolated to infinity (AUC0-inf)of FP002
Time frame: up to 24 months
Time to reach maximum plasma concentration (Tmax) of FP002
Time frame: up to 24 months
Terminal elimination half-life (t1/2) of FP002
Time frame: up to 24 months
Apparent volume of distribution (Vd) of FP002
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Time frame: up to 24 months
Clearance rate (CLz)
Time frame: up to 24 months
Terminal elimination rate constant (λz)
Time frame: up to 24 months
Mean retention time (MRT)
Time frame: up to 24 months
Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)
Time frame: up to 24 months
Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)
Time frame: up to 24 months
Average steady state concentration (Cav)
Time frame: up to 24 months
Steady-state clearance rate (CLss)
Time frame: up to 24 months
Steady-state volume of distribution (Vss)
Time frame: up to 24 months
Accumulation index (Rac)
Time frame: up to 24 months
Degree of fluctuation (DF)
Time frame: up to 24 months
Duration of response (DoR) based on RECIST V1.1
Time frame: Up to 24 months
Disease control rate (DCR) based on RECIST V1.1
Time frame: Up to 24 months
Overall response rate (ORR) based on RECIST V1.1
Time frame: Up to 24 months
Progression free survival (PFS) based on RECIST V1.1
Time frame: Up to 24 months
Anti-drug antibody
Incidence, onset time and titer
Time frame: Up to 24 months
Neutralizing antibody
Incidence, onset time and titer
Time frame: Up to 24 months
Receptor of occupancy in RBC/CD3+ T cell
Time frame: Up to 24 months