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A Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVs Carrying the Cytotoxic Drug PNU-159682 (EGFR-VEDVsPNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDVs40-mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options
EnGeneIC Pty Ltd
The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy PNU-159682, given with EDVs40-mer.
Who is it for?
You may be eligible to enroll in this trial if you are aged 18 to 75 years old and have an advanced solid tumour that is metastatic or unresectable which cannot be treated with standard care or for which standard care treatment is no longer effective.
All participants enrolled in this trial will receive combination treatment with the following:
1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer.
2. The Cancer Treatment. The study drug is called PNU-159682 (EGFR-VEDVsPNU). PNU-159682 is a type of chemotherapy. The study drug is packaged inside the EDVs and is delivered directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDVs40-mer.
3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to fail and/or to die.
Treatment will be administered in 9-week cycles. The treatment is combined in a syringe and administered in to a vein (intravenous), over a period of 20 minutes using a special pump. One injection of the treatment mixture is given per week for the first 8 weeks of the cycle, followed by one week for CT or MRI scanning to evaluate the tumour response to treatment. Treatment will continue for up to 12 months or until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur. Each participant will receive one of three possible dose levels, depending on when they are enrolled and on the drug effects in previous participants.
It is hoped that the findings from this trial will provide information on whether EGFR-VEDVsPNU and EDVs40-mer treatment may be safe and effective for the treatment of otherwise incurable advanced solid tumours.