A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

NCT00419328 ↗

Phase 1 Completed 16 enrolled AGC Biologics S.p.A.

NaSingle-groupOpen-labelTreatment

Summary

The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Timeline

Start: 2005-03
Primary completion: 2007-09
Completion: 2007-09

Publications

Results Gregorc V, Citterio G, Vitali G, Spreafico A, Scifo P, Borri A, Donadoni G, Rossoni G, Corti A, Caligaris-Cappio F, Del Maschio A, Esposito A, De Cobelli F, Dell'Acqua F, Troysi A, Bruzzi P, Lambiase A, Bordignon C. Defining the optimal biological dose of NGR-hTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer. 2010 Jan;46(1):198-206. doi: 10.1016/j.ejca.2009.10.005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NGR-hTNF	Protein / enzyme biologic	0.2 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	0.4 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	0.8 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	1.6 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	3.2 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	6.4 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	12.8 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	19.2 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	28.8 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	43.2 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	64.8 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	86.2 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	114.6 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	152.4 ug/m2	Intravenous

Indications

No indication recorded.