Ignite Creation Date:
2024-05-05 @ 10:56 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211691
Status:
SUSPENDED
Last Update Posted:
2015-11-17
First Post:
2010-09-24
Brief Title:
Study of KB004 in Subjects With Hematologic Malignancies Myelodysplastic Syndrome MDS Myelofibrosis MF
Sponsor:
Humanigen Inc
Organization:
Humanigen Inc
Study Overview
Official Title:
Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
Status:
SUSPENDED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
KaloBios to Wind Down Operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a global multicenter open-label repeat-dose Phase 12 study consisting of a Dose Escalation Phase Phase 1 and a Cohort Expansion Phase Phase 2 In both phases KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle
Detailed Description:
The purpose of Phase 1 is to determine a maximum tolerated dose MTD for KB004 when administered to subjects with hematologic malignancies who meet the entry criteria Phase 1 has completed enrollment July of 2014 the recommended Phase 2 dose is 250 mg AML 20 mg Cohort completed enrollment Dec 2014
The purpose of Phase 2 is to characterize preliminary clinical activity The Phase 2 portion of the study consists of two parts
Part A Subjects with AML or MDS who meet the entry criteria
Part B Subjects with MF who meet the entry criteria
The purpose of Phase 2 is to characterize preliminary clinical activity The Phase 2 portion of the study consists of two parts
Part A Subjects with AML or MDS who meet the entry criteria
Part B Subjects with MF who meet the entry criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None