NCT01397708View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Melanoma
Interventions
BIOLOGICAL

INXN-2001

"* approximately 1.0 x 1012 viral particles (vp) per injection~* one intratumoral injection of INXN-2001 per study cycle~* maximum of 6 study cycles"

DRUG

INXN-1001

"* 4 dose cohorts (5mg/day, 20mg/day, 100mg/day, and 160mg/day)~* 7 oral daily doses of INXN-1001 per study cycle~* maximum of 6 study cycles~* 1 Expansion cohort at a single dose level at or below MTD (160mg/day)"

Trial Locations (9)

15232

St. Lukes, Easton

40202

James Graham Brown Cancer Center, Louisville

46526

Indiana University Health Goshen Center for Cancer Care, Goshen

60068

Oncology Specialists, Park Ridge

63110

Washington University, St Louis

75201

Mary Crowley Cancer Research Center, Dallas

90404

The Angeles Clinic, Los Angeles

07960

Atlantic Melanoma Center, Morristown

05401

Fletcher Allen Health, Burlington

Sponsors
All Listed Sponsors
lead

Alaunos Therapeutics

INDUSTRY

NCT01397708 - Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma | Biotech Hunter | Biotech Hunter