drugset / Trial / NCT05772455

A Study of XZB-0004 in Patients With Solid Tumors

NCT05772455 ↗

Phase 1 Recruiting 128 enrolled Xuanzhu Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-24
Primary completion
2025-06
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject XZB-0004 Small molecule 100 mg —
Subject XZB-0004 Small molecule 150 mg —
Subject XZB-0004 Small molecule 200 mg —