drugset / Trial / NCT01397708
Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |