Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740917
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-02-13
Brief Title:
To Evaluate the Phase I Clinical Study of XZB-0004 in Patients With AML and MDS
Sponsor:
Xuanzhu Biopharmaceutical Co Ltd
Organization:
Xuanzhu Biopharmaceutical Co Ltd
Study Overview
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 RelapsedRefractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter Phase I study that will enroll patients with relapsedrefractory AML or MDS Stage Ia and stage Ib are included in this study Phase Ia is a single-agent dose-escalation study that enrolling RR 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 RR AML patients group 1 and RR MDS patients group 2 at RP2D doses to further evaluate and determine the efficacy and safety of XZB-0004 in RR AML or RR MDS patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None