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

NCT01058538

Phase 1/2 Completed 33 enrolled Philogen S.p.A. Syneos Health · collab
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

EvaluationDrugModalityDoseRoute
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

Indications