A study of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy, E-EDV-D682 given simultaneously as non-targeted EDVs carrying an immune enhancer called EDV-GC, in participants with advanced pancreatic and other cancers whose disease has progressed after one or two treatment regimes, or where other standard therapies are not appropriate.
- Conditions
- Pancreatic CancerAdvanced Cancer (Solid Tumours)Cancer - PancreaticCancer - Any cancer
- Registration Number
- ACTRN12619000385145
- Lead Sponsor
- EnGeneIC Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 53
1. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
2. Life expectancy greater than or equal to 3 months
3.Histologically or cytologically confirmed pancreatic cancer or other solid tumours known to express EGFR including, but not limited to, kidney cancer (renal cell adenocarcinoma), melanoma, bladder cancer, colorectal cancer, non-small cell lung cancer (NSCLC) and head and neck cancer.
4.Measurable disease per iRECIST criteria.
5.Must be able to undergo CT or MRI (+/- PET) evaluation.
6.Available archived primary or metastatic neoplastic tumour tissue available for EGFR expression staining.
7.Adequate haematological function.
8.Adequate renal function
9.Adequate hepatic function
11.Adequate cardiac function with LVEF greater than or equal to 50% at baseline.
12.Serum phosphate levels within normal range (2.1-4.1 mg/dL) at baseline.
13.Cortisol levels within normal range, in accordance with hospital accredited laboratory reference range.
1.Significant pericardial effusions, pleural effusions or ascites.
2.Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids.
3.Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy.
4.Clinically significant electrocardiogram (ECG) changes at enrolment which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
5.Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis.
6.History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled on low dose molecular weight heparins or low dose aspirin.
7.Active or uncontrolled severe infection.
8.Previous or current primary malignancies at other sites within last 2 years, except:
-In situ carcinoma of the cervix.
-Adequately treated basal cell or squamous cell carcinoma of the skin.
9.Received the following procedures within 28 days prior to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:
-other investigational therapy
-radiotherapy
-any major surgery.
10.Prior other therapies or procedures prior to receiving their first dose:
-Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin.
-QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes.
11.Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
12.Female who is pregnant or breastfeeding.
13.Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method