Solid Tumors Clinical Trial
Official title:
A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer
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.
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.
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|---|---|---|---|
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