Clinical Trial

A Study of XZB-0004 in Patients With Solid Tumors

Recruiting Phase 1
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Record status
This record was last updated October 28, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL. This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-03-05.
Status change: Not Yet Recruiting → Recruiting 2024-10-23
Trial Details
NCT Number NCT05772455
Lead Sponsor Xuanzhu Biopharmaceutical Co., Ltd.
Conditions Advanced Solid Tumor, NSCLC
Enrollment 128 participants
Start Date 2023-03-24
Primary Completion 2025-06 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2024-10-28