NCT05740917

To Evaluate the Phase I Clinical Study of XZB-0004 in Patients With AML and MDS

A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Initial Efficacy of XZB-0004 in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter Phase I study that will enroll patients with relapsed/refractory AML or MDS. Stage Ia and stage Ib are included in this study. Phase Ia is a single-agent dose-escalation study that enrolling R/R AML subjects to identify XZB-0004 monotherapy MTD (if any) and RP2D and evaluate its safety and pharmacokinetic profile. Phase Ib will be an expanded study in R/R AML patients (group 1) and R/R MDS patients (group 2) at RP2D doses to further evaluate and determine the efficacy and safety of XZB-0004 in R/R AML or R/R MDS patients.

Conditions

• AML
• MDS

Interventions

Type	Name	Description
DRUG	XZB-0004	XZB-0004 orally Twice daily of every 28-day cycle

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2023-02-23
• Last updated: 2023-02-23

Locations

1 site across 1 country: China