A feasibility and efficacy study of anti-human Epidermal Growth Factor Receptor (Vectibix sequence) targeted EnGeneIC Delivery Vehicle (also known as EnGeneIC Dream Vector) containing clinician chosen therapeutic payload(s) (cytotoxic drug or functional nucleic acids) in patients with advanced cancer who have no curative treatment options.
- Conditions
- Advanced Solid tumoursCancer - Other cancer types
- Registration Number
- ACTRN12613001249741
- Lead Sponsor
- EnGeneIC Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 25
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess anti-tumour response and overall survival (OS) in patients with advanced solid tumours who have run out of all treatment options.<br><br>This is a composite primary outcome. <br><br>The primary outcome will be assessed by baseline imaging using MRI, CT or PET scans of the known tumour sites of disease as well as scans of the chest, abdomen and pelvis if not already performed. MRI or PET scans may be used for tumour assessment if felt to delineate disease better. Scans will be repeated after each 8 week cycle (Week 9). The same method of assessment and the same technique will be used to characterise each identified lesion at baseline and subsequent assessments. Disease responses will be categorised using RECIST criteria (Version 1.1).. [Anti-tumour response will be assessed after each 8 week cycle (Week 9) during treatment phase. ]
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of VEDVs carrying different therapeutic payloads in patients with advanced solid tumours.[All subjects will be closely monitored for adverse events and under go safety assessments whilst on study treatment, in accordance with the protocol schedule. <br>Safety data will be reviewed after each 5 subjects have enrolled. Each review will include all available data on the incidence of adverse events (including serious, treatment-related, and events requiring the discontinuation of investigational product). All subjects will be asked to complete a safety follow-up visit 30-35 days after withdrawal from study treatment. ]