NCT00815607

Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma

Phase 1b' Open Label, Single Arm, Multicenter Trial to Evaluate the Safety, Tolerance, Response Rate and Immunological Effects of Repeated Intratumoral Injections of Adenoviral Transduced Autologous Dendritic Cells Engineered to Express hIL-12(INXN-3001) in Response to an Oral Activator Ligand in Patients With Unresectable Stage III C or IV Malignant Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of an investigational combination drug/immunotherapy for the treatment of Stage III/IV melanoma.

Detailed description

This study will examine the effects of an oral Activator Ligand administration to modulate the timing of gene expression of human IL-12 by adenovirus-transduced dendritic cells injected into tumors.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	INXN-1001	Capsules given once daily for 14 days for 3 treatment cycles.
BIOLOGICAL	INXN-3001	Intratumoral injection

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2008-12-30
• Last updated: 2013-07-18

Locations

8 sites across 1 country: United States