None listed
Conditions
Brief summary
This study looks at treatment with a targeted biological therapy (Epidermal Growth Factor Receptor [EGFR] Targeted, Paclitaxel Loaded EnGeneIC Delivery Vehicles [ErbituxEDVsPac]) in people with advanced epithelial cancer. Who is it for? You can join this study if you have: – advanced epithelial cancer which has spread to secondary or distant sites or cannot be removed by surgery – a tumour type known to express EGFR. Trial details All participants will receive ErbituxEDVsPac Dose at increasing doses. The study will monitor the safety and effectiveness of treatment, in particular the immune and inflammatory response (measured after each treatment) and the tumour response (measured after each six week cycle of treatment).
Interventions
EGFR targeted, Paclitaxel loaded EnGeneIC Delivery Vehicle (EDV) An EDV is an anucleate bacterially derived minicell. EDVs can be loaded with chemotherapy, in this case paclitaxel. The EDV is coated with EGFR antibodies to enable it to attach to cancer cells. The EDVs are administered by intravenous infusion. This is a dose escalation study with potentially 6 levels. The doses are stated as number of EDVs given. The starting dose is 1X10e8 EDVs and increasing to a maximum of 2X10e11 EDVs. Each d
EGFR targeted, Paclitaxel loaded EnGeneIC Delivery Vehicle (EDV) An EDV is an anucleate bacterially derived minicell. EDVs can be loaded with chemotherapy, in this case paclitaxel. The EDV is coated with EGFR antibodies to enable it to attach to cancer cells. The EDVs are administered by intravenous infusion. This is a dose escalation study with potentially 6 levels. The doses are stated as number of EDVs given. The starting dose is 1X10e8 EDVs and increasing to a maximum of 2X10e11 EDVs. Each dose is given as a 20mL injection administered slowly over a period of 20 minutes. Patients are treated in cycles of 5 infusions administered at weekly intervals, separated by a treatment free week. Patients may continue in the study if their tumor is stable or responding. Patients with progressive disease may be able to continue treatment if there are no other proven treatment options available to them
Sponsors
EnGeneIC Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with advanced solid tumours that are metastatic or unresectable. Patients must have tumour types known to express EGFR.
Exclusion criteria
Previous treatment with taxanes, treatment with EGFR inhibitor or other chemotherapy or radiotherapy in past 30 days, salmonella vaccination in past 12 months, hypersensitivity to monoclonal antibodies or taxanes, uncontrolled brain metastases
Outcome results
None listed