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

AML Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05740917
Study type Interventional
Source Xuanzhu Biopharmaceutical Co., Ltd.
Contact Xiujie Zhang
Phone +86-13671737230
Email zhangxiujie@xuanzhubio.com
Status Not yet recruiting
Phase Phase 1
Start date February 2023
Completion date February 2023
View Details
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