Ignite Creation Date:
2024-05-06 @ 2:29 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054351
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2014-01-29
Brief Title:
Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer OVAR
Sponsor:
Ganymed Pharmaceuticals GmbH
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A First-in-human Dose Escalation and Dose Finding Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer OVAR
Status:
COMPLETED
Status Verified Date:
2021-11
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:
OVAR
Brief Summary:
Advanced ovarian cancer is a high medical need indication Cure is not available to these patients and treatment has palliative intent A proportion of advanced stage ovarian cancer expresses substantial levels of Claudin 6 CLDN6 a carcino-embryonic transmembrane protein which is absent from normal adult human tissue IMAB027 is a monoclonal antibody that binds to CLDN6 Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity This trial is a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with recurrent advanced ovarian cancer to assess the safety and tolerability the pharmacokinetics the antitumoral activity and the immunogenicity of IMAB027
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002755-15 | EUDRACT_NUMBER | None | None |
| 1650-CL-0101 | OTHER | Astellas Pharma Global Development Inc | None |