A study of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy PNU-159682, given simultaneously as non-targeted EDVs carrying an immune enhancer called EDV-60mer, in participants with advanced cancer who have no curative treatment options. .

Phase 1

Active, not recruiting

• Conditions: Cancer; Advanced Solid Tumours; Cancer - Any cancer

• Registration Number: ACTRN12617000037303
• Lead Sponsor: EnGeneIC Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-10
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified