The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer
- Conditions
- Advanced Hematologic MalignanciesAdvanced Solid Tumors
- Interventions
- Registration Number
- NCT04991129
- Lead Sponsor
- Suzhou Junjing BioSciences Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description WJ01024 80mg QW repeat dose every 28 days WJ01024 - WJ01024 5mg QD repeat dose every 28 days WJ01024 - WJ01024 5mg BID repeat dose every 28 days WJ01024 - WJ01024 10mg BID repeat dose every 28 days WJ01024 - WJ01024 40mg BIW repeat dose every 28 days WJ01024 - WJ01024 60mg BIW repeat dose every 28 days WJ01024 - WJ01024 50mg QW repeat dose every 28 days WJ01024 - WJ01024 40mg QW repeat dose every 28 days WJ01024 - WJ01024 80mg BIW repeat dose every 28 days WJ01024 - WJ01024 60mg QW repeat dose every 28 days WJ01024 -
- Primary Outcome Measures
Name Time Method The incidence of adverse events (AE) and serious adverse events (SAE) were assessed 2 years 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
- Secondary Outcome Measures
Name Time Method Kel 2 years Elimination rate constant
t1/2 2 years Elimination half life time
CL/F 2 years Clearance
Vd/F 2 years Apparent volume of distribution
Rac 2 years Accumulation factor
PFS 2 years Progression-free survival
DOR 2 years Duration of Response
DCR 2 years Disease Control Rate
Cmax 2 years Maximum Plasma Concentration
Tmax 2 years Time to Cmax
AUC0-t 2 years Area under the concentration versus time curve from time 0 to the last measurable concentration
AUC0-inf 2 years AUC from time 0 to infinity
ORR 2 years DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0
Trial Locations
- Locations (4)
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Harbin The First Hospitall
🇨🇳Harbin, Heilongjiang, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Beijing Cancer Hospital
🇨🇳Beijing, 北京市, China