NCT02301754

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy

A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Invectys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

Detailed description

This is the first-in-patient study of INVAC-1, a DNA vaccine encoding human telomerase reverse transcriptase (hTERT). hTERT is the catalytic subunit of the telomerase complex which synthesizes telomeric DNA at the chromosome ends. hTERT is overexpressed in most human tumors and virtually all types of cancers. INVAC-1 is developed for cancer therapy. Stimulation of the immune system directed against telomerase expressing cancer cells has the potential to generate tumor responses. The study is designed to evaluate the safety and pharmacodynamics (PD) of INVAC-1 administered alone by intradermal route to adults with solid tumor malignancies. As shown in non-clinical studies, the efficacy of the vaccine is enhanced by electroporation, which thus will be combined with the vaccination in the present study. The general clinical plan includes development of INVAC-1 in both hematologic malignancies and solid tumors, as a single agent and in combination with other targeted anticancer agents such as check-points inhibitors, radiotherapy or chemotherapies.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	INVAC-1	intradermal injection combined with electroporation

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-02-01
• Completion: 2018-06-01
• First posted: 2014-11-26
• Last updated: 2019-02-26

Locations

2 sites across 1 country: France