A Phase 1 study of anti-human EGFR (Vectibix sequence) targeted EDVs carrying cytotoxic drug, siRNA or miRNA (VEDVsPayload) in Patients with Advanced Solid Tumours who have no curative treatment options.

EnGeneIC Pty Limited0 个研究点目标入组 25 人开始时间: 2013年11月13日最近更新: 2020年1月13日

适应症

试验速览

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•Adult patients with histologically or cytologically confirmed advanced solid tumour that are metastatic or unresectable and for which standard curative or palliative measures are not available or are no longer effective. Participants will have an archived, or recent primary or metastatic tumour biopsy sample(s) (paraffin block or slide) for analysis of Epidermal Growth Factor Receptor (EGFR) expression. Postivie EGFR expression is not a pre-requisite for study inclusion. In addition, radiological assessment by MRI, CT or PET scan confirming measurable disease is also required for study entry.

•1.Prior therapy with an EGFR inhibitor within 30 days prior to first dose;
•2.Patients who have received treatment with anti-angiogenic agents within 6 weeks prior to the first dose;
•3.Patients who have received treatment with Immunotherapeutic agents or monoclonal antibody therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such cancer therapy;
•4.Patients who have received treatment with alkylating agents within 6 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy;
•5.Patients who have received chemotherapy or radiotherapy, within 4 weeks of study entry;
•6.Previous exposure to the payload of the particular Investigational agent.
•7..Patients who have had vaccination against Salmonella serovars within 12 months of study entry or patients who are positive for antibodies to salmonella species;
•8.Patients with significant pericardial effusions, pleural effusions or ascites.
•9.Unstable diabetes mellitus or other contraindications for the use of dexamethasone.
•10.Uncontrolled concurrent cardiac disease including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

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