Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378437
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-18
Brief Title:
A Study of GLB-001 in Patients With Myeloid Malignancies
Sponsor:
Hangzhou GluBio Pharmaceutical Co Ltd
Organization:
Hangzhou GluBio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Study GLB-001-02 is a phase 1 open-label clinical study to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera PV essential thrombocythemia ET myelofibrosis MF lower-risk myelodysplastic syndrome LR-MDS higher-risk myelodysplastic syndromes HR-MDS and acute myeloid leukemia AML This study consists of 3 parts dose escalation Phase 1a dose exploration Phase 1b and dose expansion Phase 1c Dose escalation Phase 1a and dose exploration Phase 1b will evaluate the safety tolerability PK PD and preliminary efficacy of GLB-001 administered orally in study participants with PVET or study participants with MFLR-MDSHR-MDSAML respectively Dose expansion Phase 1c will be followed to determine the relationships among dose exposure toxicity tolerability and clinical activity to identify minimally active dose and to select the recommended doses for phase 2 study Approximately 108 study participants may be enrolled in the study
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