This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered orally once every day to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Patients with advanced breast cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study: a dose-escalation stage and a dose-expansion stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors.
Evaluate the TEAE (treatment-emergent adverse event) of IMP4297
Time frame: Each visit after IMP4297 administrated (through study completion, an average of 10 months)
The maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLTs) of IMP4297
Evaluate DLT and determine the MTD
Time frame: Within 28 days after IMP4297 administrated
Area Under Curve [AUClast, AUCINF]
Time frame: Within 7 days after firstly single dose administrated
Area Under Curve [AUClast, AUCINF]
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Maximum plasma concentration (Cmax)
Time frame: Within 7 days after firstly single dose administrated
Maximum plasma concentration (Cmax)
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Time at which Cmax occurred (Tmax)
Time frame: Within 7 days after firstly single dose administrated
Time at which Cmax occurred (Tmax)
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Trough Concentrations (Ctrough)
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Time frame: Within 7 days after firstly single dose administrated
Trough Concentrations (Ctrough)
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Clearance (CL/F)
Time frame: Within 7 days after firstly single dose administrated
Clearance (CL/F)
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Volume of distribution (Vd/F)
Time frame: Within 7 days after firstly single dose administrated
Volume of distribution (Vd/F)
Time frame: Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)