drugset / Trial / NCT01058538
A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I/II 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).
Timeline
- Start
- 2005-11
- Primary completion
- 2008-04
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darleukin | Protein / enzyme biologic | 5e+06 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 1e+07 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 1.5e+07 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 2e+07 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 2.25e+07 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 3e+07 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 4e+07 iu | Intravenous |