Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 75
Trial acronym
The Carolyn Trial (ENG9)
Clinical summary
Summary
All patients enrolled in this clinical trial will receive a combination treatment, which contains the EnGeneIC Dream Vector (EDV(TM)), the study drug (chemotherapy) and the bispecific antibody. Treatment will be given in 8-week cycles and is combined in a syringe and administered intravenously, over a period of 20 minutes using a special pump. One dose of the treatment is given each week for the first 7 weeks, followed by a treatment free week (week 8) where a CT or MRI scan is performed to evaluate the tumours response.
Conditions
This trial is treating people with pancreatic cancer or other EGFR expressing cancers
Eligibility
Inclusion
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.
Exclusion
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.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
EnGeneIC Pty Ltd
Scientific Title
A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying an immunomodulator (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information