Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01058538
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2010-01-27
Brief Title:
A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2014-02
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 a Phase III study for patients with solid tumors and renal cell carcinoma RCC for the Phase II part L19-IL2 is a tumor targeted immunocytokine constituted of a single chain Fragment variable scFv format directed against the ED-B domain of fibronectin one of the most important markers for neoangiogenesis and the human cytokine interleukin-2 IL2
Detailed Description:
This is an open-label non-randomised multicentre Phase III study to assess safety pharmacokinetics PK and early signs of activity of L19-IL2 monotherapy
In the first part of the study there will be 5 dose escalation steps in sequential cohorts of patients with advanced solid tumours In the second part of the study patients with advanced RCC will be given a fixed dose of L19IL2 at the RD
In the first part of the study there will be 5 dose escalation steps in sequential cohorts of patients with advanced solid tumours In the second part of the study patients with advanced RCC will be given a fixed dose of L19IL2 at the RD
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 |
|---|---|---|---|
| 2005-002716-16 | EUDRACT_NUMBER | None | None |