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

NCT05740917 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-02-23

No results posted yet for this study

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

Interventions

DRUG

XZB-0004

XZB-0004 orally Twice daily of every 28-day cycle

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740917 on ClinicalTrials.gov