Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

August 12, 2019

Study Completion Date

August 4, 2020

Conditions
Ewing's SarcomaEwing Family of TumorsEwing's Tumor MetastaticEwing's Sarcoma MetastaticEwing's Tumor RecurrentRare DiseasesSarcoma
Interventions
BIOLOGICAL

pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex

"Lipoplex is given intravenously as a single administration twice a week for 4 weeks for a total of 8 infusions per cycle followed by 2 weeks of rest. Treatment may continue as long as there is clinical benefit, no evidence of disease progression, and no other withdrawal criteria are met.~First dose started on Cycle 1 Week 1 Day 1 followed by observation and safety assessment for 13 days. If no toxicity was observed, then another single administration of study agent was given at Cycle 1 Week 3 Day 1 followed by observation and safety for 6 days. If no toxicity was observed, then study agent was given twice a week on Days 1 and 4 over 3 weeks, for a total of 8 infusions per cycle, followed by a 2-week washout before starting each subsequent cycle. Cycle 1 = 8 weeks. Each subsequent cycles = 6 weeks."

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

75230

Mary Crowley Cancer Research Centers, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gradalis, Inc.

INDUSTRY