NCT04991129

The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer

A Dose Escalation and Dose Expansion Study of WJ01024 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy for Patients With Advanced Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Suzhou Junjing BioSciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hematologic Malignancies
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	WJ01024	5mg QD: WJ01024, Q4W, once per day
DRUG	WJ01024	5mg BID: WJ01024, Q4W, twice per day
DRUG	WJ01024	10mg BID: WJ01024, Q4W, twice per day
DRUG	WJ01024	40mg BIW: WJ01024, Q4W, twice per week
DRUG	WJ01024	60mg BIW: WJ01024, Q4W, twice per week
DRUG	WJ01024	80mg BIW: WJ01024, Q4W, twice per week
DRUG	WJ01024	60mg QW: WJ01024, Q4W, once per week
DRUG	WJ01024	80mg QW: WJ01024, Q4W, once per week
DRUG	WJ01024	50mg QW: WJ01024, Q4W, once per week
DRUG	WJ01024	40mg QW: WJ01024, Q4W, once per week

Timeline

• Start date: 2021-09-10
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2021-08-05
• Last updated: 2025-06-26

Locations

4 sites across 1 country: China