drugset / Trial / NCT01397708

Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma

NCT01397708

Phase 1/2 Completed 26 enrolled Alaunos Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of tumor injections of INXN-2001 given in combination with different doses of INXN-1001.

Timeline

Start
2011-08
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad-RTS-hIL-12 Unknown 1e+12 unknown Intramuscular
Subject veledimex Small molecule 5 mg Oral
Subject veledimex Small molecule 20 mg Oral
Subject veledimex Small molecule 100 mg Oral
Subject veledimex Small molecule 160 mg Oral

Indications