This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of HP007 monotherapy in patients with advanced malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Participate will recepit HP007 monotherpy with 4 dose groups
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGDLT
Safety endpoints: incidence and severity of DLT
Time frame: up to one year
AE
Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance
Time frame: up to two years
SAE
Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance
Time frame: up to two years
MTD
Maximum tolerated dose (MTD)
Time frame: up to one year
RP2D
Recommended dose for phase II trial
Time frame: up to one year
ORR
Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1 or mRecist 1.1 or PCWG3
Time frame: up to two years
DOR
Efficacy endpoints: Duration of response (DOR) per RECIST v1.1 or mRecist 1.1 or PCWG3
Time frame: up to two years
DCR
Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1 or mRecist 1.1 or PCWG3
Time frame: up to two years
PFS
Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1 or mRecist 1.1 or PCWG3
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Time frame: up to two years
OS
Efficacy endpoints: Overall survival (OS)
Time frame: up to two years
Peak concentration(Cmax)
The pharmacokinetic parameters of WJ47156:peak concentration (Cmax)
Time frame: up to two years
the time to receive Cmax(Tmax)
The pharmacokinetic parameters of HP007:the time to receive Cmax (Tmax)
Time frame: up to two years
Area Under the plasma concentration-time curve (AUC0-t, AUC0-∞)
The pharmacokinetic parameters of HP007 :area under the plasma concentration-time curve (AUC0-t, AUC0-∞)
Time frame: up to two years
Volume of distribution (Vd)
The pharmacokinetic parameters of HP007 :Volume of distribution (Vd)
Time frame: up to two years
Rate of clearance (C)
The pharmacokinetic parameters of HP007 :Rate of clearance (CL)
Time frame: up to two years
Terminal half-life (t1/2)
The pharmacokinetic parameters of WJ47156 :terminal half-life (t1/2),
Time frame: up to two years
Steady-state peak concentration(Cmax,ss)
The pharmacokinetic parameters of HP007 :steady-state peak concentration(Cmax,ss) for the main PK parameters for multiple dose
Time frame: up to two years
Plasma trough concentration at steady state(Cmin,ss)
The pharmacokinetic parameters of HP007:Plasma trough concentration at steady state(Cmin,ss) for the main PK parameters for multiple dose
Time frame: up to two years
Accumulation ratio for AUC
The pharmacokinetic parameters of HP007:Accumulation ratio of area-under-the-curve, defined as steady-state AUC within one dosing interval divided by Day 1 AUC (typically AUC₀-₂₄h). It characterizes overall systemic exposure accumulation over the dosing cycle, used for efficacy and total exposure assessment.
Time frame: up to two years
the time to receive Cmax at steady state(Tmax,ss)
The pharmacokinetic parameters of HP007 :the time to receive Cmax at steady state(Tmax,ss)for the main PK parameters for multiple dose)
Time frame: up to two years
Area Under the plasma concentration-time curve at steady state (AUC0-t, ss)
The pharmacokinetic parameters of HP007:area under the plasma concentration-time curve at steady state (AUC0-t, ss)for the main PK parameters for multiple dose)
Time frame: up to two years
ADA
The incidence and changes of anti-drug antibody (ADA) after treatment were observed
Time frame: up to two years
Nab
The incidence and changes of neutralizing antibody (Nab) after treatment were observed
Time frame: up to two years
Cytokines
The changes of serum cytokines (IFN-α, IFN-γ, IL-6, IL-10, and chemokines IFN-γ-inducible protein 10 (IP-10) and TNF-α )in peripheral blood before and after treatment were observed
Time frame: up to one year
Subtype of lymphocyte
Flow cytometry was used to detect the changes in lymphocyte subsets in peripheral blood before and after treatment
Time frame: up to one year