Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146257
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-11-10
Brief Title:
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
Sponsor:
GluBio Therapeutics Inc
Organization:
GluBio Therapeutics Inc
Study Overview
Official Title:
A First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Study GLB-001-01 is a first-in-human FIH Phase 1 open-label dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia RR AML or in participants with relapsed or refractory higher-risk myelodysplastic syndromes RR HR-MDS The dose escalation part Phase 1a of the study will evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of GLB-001 administered orally Approximately 24 participants up to 42 participants may be enrolled in Phase 1a of the study
The dose expansion part Phase 1b will be followed to understand 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 Up to 24 participants 12 participants per dose level may be enrolled in Phase 1b of the study
The dose expansion part Phase 1b will be followed to understand 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 Up to 24 participants 12 participants per dose level may be enrolled in Phase 1b of the study
Detailed Description:
A standard 33 dose-escalation design will be applied to evaluate a set of several dose levels to determine the maximum tolerated dose MTD or maximum administered dose MAD of GLB-001 in RR AML or RR HR-MDS patients who are eligible for DLT evaluation The actual dose-escalation magnitude or dosing frequency may be adjusted based on the available PK and safety data in human
After the MTD or MAD of GLB-001 is defined in Phase 1a 1 or 2 dose levels will be selected for expansion per safety review committee SRC recommendation approximately 12 patients will be enrolled per dose level Recommended phase 2 dose RP2D will be selected based on the results of PK PD safety and efficacy in the dose escalation and expansion study
After the MTD or MAD of GLB-001 is defined in Phase 1a 1 or 2 dose levels will be selected for expansion per safety review committee SRC recommendation approximately 12 patients will be enrolled per dose level Recommended phase 2 dose RP2D will be selected based on the results of PK PD safety and efficacy in the dose escalation and expansion study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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