A clinical study of WJ01024 in subjects with advanced cancer in China, to evaluate the safety, tolerability, PK and efficacy of WJ01024. This study includes a dose escalation part and a dose expansion part. Patients receive WJ01024 on Day 1 and Day 3 of each week, 4 weeks as a cycle, until disease progression, or intolerable toxicity , withdrawal of consent, or end of the study, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Harbin The First Hospitall
Harbin, Heilongjiang, China
Jilin Cancer Hospital
Changchun, Jilin, China
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
Time frame: 2 years
ORR
DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0
Time frame: 2 years
DOR
Duration of Response
Time frame: 2 years
DCR
Disease Control Rate
Time frame: 2 years
PFS
Progression-free survival
Time frame: 2 years
Cmax
Maximum Plasma Concentration
Time frame: 2 years
Tmax
Time to Cmax
Time frame: 2 years
AUC0-t
Area under the concentration versus time curve from time 0 to the last measurable concentration
Time frame: 2 years
AUC0-inf
AUC from time 0 to infinity
Time frame: 2 years
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40mg BIW: WJ01024, Q4W, twice per week
60mg BIW: WJ01024, Q4W, twice per week
80mg BIW: WJ01024, Q4W, twice per week
60mg QW: WJ01024, Q4W, once per week
80mg QW: WJ01024, Q4W, once per week
50mg QW: WJ01024, Q4W, once per week
40mg QW: WJ01024, Q4W, once per week
Kel
Elimination rate constant
Time frame: 2 years
t1/2
Elimination half life time
Time frame: 2 years
CL/F
Clearance
Time frame: 2 years
Vd/F
Apparent volume of distribution
Time frame: 2 years
Rac
Accumulation factor
Time frame: 2 years