A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Neoplasm
Interventions
GENETIC

SGT-94

SGT-94 will be given at doses of 0.6, 1.2, 2.4, 3.6 and 4.8 mgDNA/infusion(Doses 0-5, respectively)twice weekly for 3 weeks out of 4 in dose levels 0 to 4, and for 5 weeks out of 6 for dose level 5 (also 4.8mg DNA). Intravenous infusion will occur over 1 to 2.5 hours in 5% dextrose,with a final volume of SGT-94 and dextrose of 100 mL to 250 mL, depending on dose level.

Trial Locations (1)

77030

University of Texas, M.D. Anderson Cancer Center, Houston

All Listed Sponsors
lead

SynerGene Therapeutics, Inc.

INDUSTRY

NCT01517464 - A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors | Biotech Hunter | Biotech Hunter