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Closed (no longer recruiting)Last updated: 29 January 2024

ENG8: This phase I trial is using a new technology (EDV) to deliver chemotherapy (PNU-159682) and immunotherapy (EDVs40-mer) drugs in patients with advanced solid tumoursA Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVs Carrying the Cytotoxic Drug PNU-159682 (EGFR-VEDVsPNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDVs40-mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options

Clinical summary

Summary

The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy PNU-159682, given with EDVs40-mer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 to 75 years old and have an advanced solid tumour that is metastatic or unresectable which cannot be treated with standard care or for which standard care treatment is no longer effective. Study details All participants enrolled in this trial will receive combination treatment with the following: 1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer. 2. The Cancer Treatment. The study drug is called PNU-159682 (EGFR-VEDVsPNU). PNU-159682 is a type of chemotherapy. The study drug is packaged inside the EDVs and is delivered directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDVs40-mer. 3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to fail and/or to die. Treatment will be administered in 9-week cycles. The treatment is combined in a syringe and administered in to a vein (intravenous), over a period of 20 minutes using a special pump. One injection of the treatment mixture is given per week for the first 8 weeks of the cycle, followed by one week for CT or MRI scanning to evaluate the tumour response to treatment. Treatment will continue for up to 12 months or until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur. Each participant will receive one of three possible dose levels, depending on when they are enrolled and on the drug effects in previous participants. It is hoped that the findings from this trial will provide information on whether EGFR-VEDVsPNU and EDVs40-mer treatment may be safe and effective for the treatment of otherwise incurable advanced solid tumours.

Conditions

This trial is treating patients with advanced solid tumours.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

Trial Acronym

ENG8

More information

Trial Identifiers

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Trial sponsor

EnGeneIC Pty Ltd

Scientific Title

A Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVs Carrying the Cytotoxic Drug PNU-159682 (EGFR-VEDVsPNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDVs40-mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options

Eligibility

Inclusion

1. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
2. Life expectancy greater than 3 months
3. Histologically or cytologically confirmed advanced solid tumour that is metastatic or unresectable and for which standard curative or palliative measures are not available or are no longer effective.
4. Measurable disease per iRECIST criteria.
5. Able to undergo CT or MRI (+/- PET) evaluation as applicable to tumour type.
6. Available archived primary or metastatic neoplastic tumour tissue available for EGFR expression staining, if not already performed as standard of care.
6.. Adequate cardiac function with LVEF greater or equal to 50% at baseline.

Exclusion

1. Significant pericardial effusions, pleural effusions or ascites.
2. Concurrent unstable diabetes mellitus or other contraindications for the use of dexamethasone.
3. Uncontrolled concurrent cardiac disease including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
4. 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.
5. 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.
6. Uncontrolled brain metastases. Subjects with a history of brain metastases are eligible if the subject is stable and off corticosteroids for at least 2 weeks prior to treatment in the study. PAtients who have undergone glucocorticoid tapering but who have not tolerated complete withdrawal and still require a nominal maintenance dose, will be reviewed on a case by case basis.
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 therapies or procedures within 28 days prior to Cycle 1, Dose 1 (or has not recovered from the toxic effects of such therapy) including:
- Therapy with an EGFR inhibitor e.g. cetuximab or erlotinib
- Anti-angiogenic therapy e.g. Bevacizumab (Avastin)
- Immunotherapeutic agents, vaccines, or monoclonal antibody therapy
- Alkylating agents
- Chemotherapy
- Radiotherapy with the exception of palliative radiotherapy
- Other investigational therapy.
- Any major surgery.
10. Prior exposure to PNU.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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