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Recruitment on holdLast updated: 22 May 2026

ENG19: This study is recruiting people with EGFR-expressing solid cancers to determine if targeted chemotherapy (E-EDV-D68) given with another immune boosting drug (called EDV-GC) is safe and effective, and to identify which cancer type is most responsive to this treatmentAn open-label, multicenter, Phase I/IIa study assessing the safety and efficacy of EGFR targeted EDVsTM carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate (EGFR EDV-D682/GC Trial)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

ENG19

Clinical summary

Summary

This study aims to determine whether EnGeneIC Dream Vectors (EDVs) carrying chemotherapy (a combination product called E-EDV-D682) are safe and effective when given with non-targeted EDVs carrying an immune enhancer (called EDV-GC) in people with advanced epidermal growth factor receptor (EGFR)-expressing cancers whose disease has progressed after one or two treatment regimens, or where other standard therapies are not appropriate. The combination of these two products is known as E-EDV-D682/GC.

In Phase I of the study, a safety assessment will be performed on 3 participants from each of the following cancer indications (types):

  • lung cancer (non-small cell lung cancer and mesothelioma),
  • bladder/kidney cancer,
  • colorectal (bowel) cancer,
  • triple negative breast cancer (TNBC),
  • pancreatic ductal adenocarcinoma (PDAC),
  • and other EGFR-expressing solid tumours such as head and neck cancer, malignant melanoma, and neuroendocrine tumours.

In Phase II, the recommended dosing regimen identified in Phase I will be expanded to a maximum of 20 participants for each cancer type.

The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC will be administered intravenously (IV). In Week 8, tumour burden will be radiologically re-evaluated to determine the response to treatment.

Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment-free week in which tumour burden will be radiologically reassessed (Week 8). Treatment may continue until the participant or investigator deems it appropriate to stop treatment, for example if serious side effects occur or if the participant’s disease continues to progress.

It is hoped that the findings from this study will help determine the safety and efficacy of EGFR-targeted EDVs carrying the cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying alpha-galactosylceramide in people with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate.

Conditions

This trial is treating people with advanced EGFR-expressing solid cancers

Eligibility

Inclusion

 • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Life expectancy of greater than or equal to 3 months.
• Measurable disease per iRECIST criteria.
• Adequate haematological function.
• Adequate renal function as follows.
• Adequate hepatic function.
• Adequate cardiac function with LVEF of greater than or equal to 50% at baseline.
• The subject must have positive EGFR expression on local IHC or liquid biopsy.

Exclusion

 • Glioblastoma.
• Significant pericardial effusions, pleural effusions, or ascites.
• Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids.
• Subject has experienced a history of uncontrolled 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.
• Clinically significant electrocardiogram (ECG) changes at enrolment which obscure the ability to assess the PR, QT, and QRS interval, congenital long QT syndrome.
• 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.
• History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via therapeutic intervention.
• Active or uncontrolled severe infection.
• Previous or current primary malignancies at other sites within last 2 years, except: In situ carcinoma of the cervix or adequately treated basal cell or squamous cell carcinoma of the skin.
• 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 or any major surgery.
• Other therapies or procedures such as 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.
• Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
• Females who are pregnant or breastfeeding.
• Subjects who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

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.
Message

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.

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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 Limited

Scientific Title

An open-label, multicenter, Phase I/IIa study assessing the safety and efficacy of EGFR targeted EDVsTM carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate (EGFR EDV-D682/GC Trial)

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