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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000203459
Ethics application status
Approved
Date submitted
20/01/2025
Date registered
20/02/2025
Date last updated
29/06/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
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 epidermal growth factor expressing cancers whose disease has progressed after one or two treatment regimes, or where other standard therapies are not appropriate. (EGFR EDV-D682/GC Trial)
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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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Secondary ID [1]
313717
0
EGFR EDV-D682/GC Trial
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Universal Trial Number (UTN)
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Trial acronym
ENG19
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Linked study record
ACTRN12619000385145 was a safety and tolerability study conducted in PDAC and Colorectal cancer patients. The current study has opened-up participation to all EGFR expressing cancer indications using the recommended phase IIa dose from ACTRN12619000385145.
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Health condition
Health condition(s) or problem(s) studied:
Lung cancer (NSCLC and Mesothelioma)
336314
0
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Triple negative breast cancer (TNBC)
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Colorectal cancer
336316
0
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EGFR expressing solid tumors
336313
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Pancreatic ductal adenocarcinoma (PDAC)
336318
0
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Bladder/Kidney cancer
336315
0
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Condition category
Condition code
Cancer
332854
332854
0
0
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Kidney
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Cancer
332853
332853
0
0
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Head and neck
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Cancer
332856
332856
0
0
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Lung - Non small cell
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Cancer
332859
332859
0
0
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Neuroendocrine tumour (NET)
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Cancer
332858
332858
0
0
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Pancreatic
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Cancer
332850
332850
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
332855
332855
0
0
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Lung - Mesothelioma
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Cancer
332852
332852
0
0
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Breast
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Cancer
332848
332848
0
0
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Bladder
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Cancer
332857
332857
0
0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study is testing an experimental treatment for people with advanced cancer after the failure of first or second line therapy or for people who do not have other treatment options. The experimental treatment consists of a chemotherapy drug, PNU-159682 packaged inside an EGFR targeted delivery vehicle to form the investigational product E-EDV-D682. The EDV delivery vehicle is used to transport the chemotherapy directly to the tumor via the blood stream where it attaches to the surface of EGFR expressing cancer cells causing the cancer cell to die.
The E-EDV-D682 are given at the same time as one other investigational product, designed to boost the body's own immune system to fight the cancer. This investigational product consists of non-targeted EDVs carrying a-galactosyl ceramide or EDV-GC.
The combination of these 2 drugs is known as E-EDV-D682/GC.
The study aims to evaluate the safety and efficacy of E-EDV-D682/GC in patients with EGFR-expressing solid tumors. The study is designed with two phases, Phase I (dose assessment) and Phase IIa (dose expansion). In Phase I of the study a safety assessment will be performed on 3 participants from each of the following cancer indications: Lung cancer (NSCLC and Mesothelioma), Bladder/Kidney cancer, Colorectal cancer, Triple negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma (PDAC) and other EGFR expressing solid tumors such as Head and Neck cancer, Malignant melanoma and Neuroendocrine tumors. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 20 participants for each cancer indication. Participants in the phase IIa dose expansion part of the trial will follow the same treatment cycle visit schedule regardless of the recommended dose level.
The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with immune Response Evaluation Criteria in Solid Tumours (iRECIST) guidelines to determine treatment response.
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 is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow.
It is estimated that the study duration for participants in the active treatment phase will be approximately 4-5 months consisting of two weeks for screening, 16 weeks of treatment (2 cycles, depending on the disease state and tolerability to the IMP and a 30-35-day safety follow-up visit.
All AEs will be monitored, and ongoing safety evaluations will be conducted by a designated Safety Monitoring Board, who will assess the progress of the trial and will be responsible for decisions as whether to continue, modify, or stop the trial.
This study is designed as a Phase I/IIa trial, with a 3-patient run in (Phase I) for each tumor indication. The Safety Monitoring Board will review the accumulated safety data after the first three evaluable patients have completed one cycle of EDV treatment. The committee will consist of the Principal Investigator and/or Co-Investigator(s), one independent oncologist with experience in Phase I/IIa studies, and at least one Sponsor representative. Each review will include all available data on the incidence of AEs (including SARs, DLTs, lab and vital sign data and events requiring the discontinuation of IMP) and deaths. Alternative or additional dosing regimens may be explored based on emerging safety data from any part of the study.
Phase IIa will start after 3 participants from each cancer indication have completed their dose limiting toxicity evaluation period (Days 1-56) and the safety committee has met to review the safety data. Participants in the phase IIa dose expansion part of the trial will follow the same treatment cycle visit schedule regardless of the recommended dose level.
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Intervention code [1]
330316
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Evaluate tumor response
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Assessment method [1]
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Evidence of anti-tumor activity will be assessed radiologically by MRI, CT or PET scans, and the response graded according to iRECIST criteria. Results for the best overall response will be presented for individual subjects, and for each cohort using frequency counts and percentages.
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Timepoint [1]
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Imaging will be performed at baseline and at the completion of every cycle of treatment (every 2 months).
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Primary outcome [2]
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To collectively assess the safety and tolerability of E-EDV-D682/GC in subjects with EGFR-expressing solid cancers
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Assessment method [2]
340383
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Safety and tolerability will be assessed during phase I and phase IIa by monitoring all participants for adverse events (AEs) and serious adverse events (SAEs) via assessment of vital signs, neurologic and physical exams, biochemistry, and hematology parameters and in accordance with CTCAE (Common Terminology Criteria for Adverse Events), Version 5 criteria. During the phase I safety assessment, a dose-limiting toxicity (DLT) evaluation will be performed on the first 3 evaluable participants from each cancer indication that have completed treatment cycle 1 (days 1 to 56).
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Timepoint [2]
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Vital signs and clinical pathology will be assessed prior to and at 3 hours following each dose for all participants throughout the study. All adverse events will be monitored throughout the trial and ongoing safety evaluations will be conducted by a designated safety monitoring board. For phase I participants, the primary timepoint is day 56.
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Primary outcome [3]
340384
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Evaluate overall survival (OS)
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Assessment method [3]
340384
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Overall survival is defined as time from the date of first administration of drug to the date of death, regardless of cause. Kaplan Meier curves will be utilised to determine percentage and median survival. Survival will be compared to historic survival data and between indications.
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Timepoint [3]
340384
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Survival will continue to be monitored for the duration of the long-term follow-up (every 3 months from the safety follow-up visit for the extent of participant survival).
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Secondary outcome [1]
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Disease control rate (DCR)
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Assessment method [1]
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Percentage of participants in each indication who have a complete or partial response or stable disease (iCR or iPR or iSD) as per iRECIST criteria following tumour assessment by MRI, CT, or PET scan.
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Timepoint [1]
443926
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Baseline (screening) and at the completion of each treatment cycle (week 8), then every 8 weeks thereafter until the participant is withdrawn from treatment.
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Secondary outcome [2]
443927
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Duration of response (DOR).
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Assessment method [2]
443927
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Calculated only for those subjects who have a confirmed disease response based on a review of MRI, CT or PET scans. Defined as time from the date of the first observed improvement to the date of the first subsequent documented disease progression or relapse.
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Timepoint [2]
443927
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Tumor response is assessed at the completion of each treatment cycle (week 8), then every 8 weeks thereafter until the participant is withdrawn from treatment. The duration of Response is the number of days between the first tumor response assessment of an objective response (PR or CR) to the date of the first tumor response assessment of progressive disease or death.
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Secondary outcome [3]
443914
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Objective response rate (ORR)
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Assessment method [3]
443914
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Percentage of participants in each indication who have a complete or partial response (iCR or iPR) as per iRECIST criteria following tumour assessment by MRI, CT, or PET scan.
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Timepoint [3]
443914
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Baseline (screening) and end of each treatment cycle (week 8 and then every 8 weeks thereafter) until the participant is withdrawn from treatment
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Eligibility
Key inclusion criteria
• 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
22/04/2025
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Date of last participant enrolment
Anticipated
11/01/2027
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Actual
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Date of last data collection
Anticipated
7/02/2028
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Actual
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Sample size
Target
160
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
27497
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Frankston Private Hospital - Frankston
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Recruitment hospital [2]
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Mater Sydney - North Sydney
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Recruitment postcode(s) [1]
43609
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2060 - North Sydney
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Recruitment postcode(s) [2]
43608
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3199 - Frankston
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Funding & Sponsors
Funding source category [1]
318183
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Commercial sector/Industry
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Name [1]
318183
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EnGeneIC Pty Limited
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Address [1]
318183
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Country [1]
318183
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
EnGeneIC Pty Limited
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Address
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Country
Australia
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Secondary sponsor category [1]
320587
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None
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Name [1]
320587
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Address [1]
320587
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Country [1]
320587
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316835
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Bellberry Human Research Ethics Committee K
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Ethics committee address [1]
316835
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https://bellberry.com.au/
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Ethics committee country [1]
316835
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Australia
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Date submitted for ethics approval [1]
316835
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10/07/2024
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Approval date [1]
316835
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22/10/2024
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Ethics approval number [1]
316835
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2024-07-880
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Summary
Brief summary
This study aims to determine whether E-EDV-D682 in combination with the adjuvant treatment, EDV-GC is safe and effective and to identify the most responsive cancer indications (advanced EGFR-expressing solid tumors) to the E-EDV-D682/GC treatment. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. A life expectancy greater than 3 months, measurable disease per iRECIST criteria, adequate haematological, renal, hepatic and cardiac function. You must have positive EGFR expression on local IHC or liquid biopsy. Study details In Phase I of the study a safety assessment will be performed on 3 participants from each cancer indication. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 20 participants for each cancer indication. The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with iRECIST to determine treatment response. 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 is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the funding from this study will help determine the safety and efficacy of EGFR targeted EDVs 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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Vinod Ganju
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Address
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Peninsula And Southeast Oncology Suites (PASO), Frankston Private Hospital, Suite 7, Level 3, 5 Susono Way Frankston, VIC 3199
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Country
139150
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Australia
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Phone
139150
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+61 412 326 883
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Fax
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Email
139150
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[email protected]
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Contact person for public queries
Name
139151
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Albert Goikhman
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Address
139151
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Peninsula And Southeast Oncology Suites (PASO), Frankston Private Hospital, Suite 7, Level 3, 5 Susono Way Frankston, VIC 3199
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Country
139151
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Australia
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Phone
139151
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+61 03 9781 5244
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Fax
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Email
139151
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[email protected]
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Contact person for scientific queries
Name
139152
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Jennifer MacDiarmid
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Address
139152
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Building 53, Level 4, 11 Julius Avenue, North Ryde, Sydney, NSW 2113
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Country
139152
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Australia
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Phone
139152
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+61 02 9420 5833
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Fax
139152
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Email
139152
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
For reasons of confidentiality
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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