drugset / Trial / NCT03679754

Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102

NCT03679754

Phase 1 Completed 36 enrolled Alaunos Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can 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 a single intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.

Timeline

Start
2018-09-05
Primary completion
2019-04-02
Completion
2021-01-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad-RTS-hIL-12 Unknown 2e+11 unknown Intravitreal
Subject veledimex Small molecule 20 mg Oral

Indications