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Trial registered on ANZCTR


Registration number
ACTRN12614001207606
Ethics application status
Approved
Date submitted
6/11/2014
Date registered
17/11/2014
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I Dose-Escalation Extension Study to Determine the Safety and Tolerability of Intratumoural Injection(s) of EBC-46
Scientific title
Phase I Dose-Escalation Extension Study to Determine the Safety and Tolerability of Intratumoural Injection(s) of EBC-46
Secondary ID [1] 285599 0
QB46C-H02
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12614000685617

Health condition
Health condition(s) or problem(s) studied:
Cutaneous, subcutaneous, head and neck*, or nodal tumours
*except for pharyngeal, laryngeal and tongue base tumours and those tumours in the anterior neck (from posterior border of sternocleidomastoid on each side) 293442 0
Condition category
Condition code
Cancer 293715 293715 0 0
Head and neck
Cancer 293716 293716 0 0
Malignant melanoma
Cancer 293717 293717 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multi-centre, single-agent, open-label, Phase I dose-escalation extension study of EBC-46 to evaluate the safety and tolerability of repeated administrations of EBC-46 in patients who have successfully completed the main protocol (QB46C-H01, ANZCTR Trial ID: ACTRN12614000685617).
Patients will undergo a screening visit up to 3 months after completing the QB46C-H01 study. Treatment will be a single dose administered via intratumoural injection with safety monitoring for 21 days. Patients will be required to return for follow up assessments on Day 2, Day 8 (plus or minus 1 day), Day 15 (plus or minus 1 day) and Day 22 (plus or minus 1 day). Treatments will continue no sooner than 1 week since the last injection and will conclude when disease progression or intolerance presents.
Patients will initially receive the same dose level as they received in QB46C-H01 (if tolerated) or lower (if not tolerated or there is less tumour mass requiring dosing). Lower doses will be considered for patients who experienced a dose limiting toxicity (DLT) or Grade > 3 adverse event (AE) in the QB46C-H01 study or if the tumour burden requires less EBC-46.
The dose may be escalated to a higher level if that higher dose level has been demonstrated to be well-tolerated in the QB46C-H01 study (based on the incidence and severity of AEs and DLTs in the QB46C-H01 study) as determined by the Safety Review Committee.
Intervention code [1] 290551 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293526 0
To determine the safety and tolerability of EBC-46 when administered via intratumoural injection(s). This will be determined by evaluation of the safety parameters collected during the study, including:
- Laboratory tests;
- 12-lead electrocardiogram (ECG);
- AEs/SAEs (toxicities will be assessed using the CTCAE V4.03);
- Local injection site reactions;
- Vital signs; and
- Wound healing.
Timepoint [1] 293526 0
Between Day 1 and Day 22 for each treatment.
Secondary outcome [1] 311261 0
The effects of EBC-46 on tumour size will be evaluated by using calliper measurements, where possible. RECIST 1.1 guidelines will be applied to evaluate response and change in treated (up to three target tumours) and non-treated (up to five non-target) tumour size(s). Volumetric analysis will also be conducted for target and non-target tumours. Callipers will be used to estimate tumour volume, and to estimate tumour response based on tumour volume relative to baseline measurements, where possible.
Timepoint [1] 311261 0
Calliper measurements, where possible, will be taken at baseline and weekly to Day 22 for each treatment period.

Eligibility
Key inclusion criteria
A patient will be eligible for study participation in the extension study if the patient
meets all of the following criteria:
1. Patient has either completed the QB46C-H01 protocol, or has been enrolled in QB46C-H02, and, in the opinion of the Investigator, might benefit from continued treatment with EBC-46;
2. Patient is able to commence the extension study (i.e. be dosed on Day 1) within 3.5 months of the last visit of the QB46C-H01 protocol;
3. Patient is able to commence another QB46C-H02 treatment period (i.e. be dosed) within 3.5 months of their last treatment;
4. Previously treated tumour(s) have a complete covering of skin (“healed”) or at least evidence of healing (e.g., reduction in size of any wound) or stabilisation;
5. Adult (18 years or older) with histologically or cytologically confirmed tumours;
6. Has cutaneous, subcutaneous, head and neck*, or nodal tumours:
- Refractory to at least one round of conventional therapy; or
- For whom there is no standard therapy; or
- Has refused standard therapy despite appropriate counselling (this will be documented); or
- That are awaiting therapy or are explicitly being monitored with the aim of delaying therapy.
These may include, but are not limited to:
i) Squamous cell carcinoma of the head and neck;
ii) Squamous cell carcinoma of the skin;
iii) Merkel cell tumours of the skin;
iv) Malignant melanoma;
v) Skin metastases.
7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
8. Has a life expectancy of more than 12 weeks;
9. Haemoglobin greater than or equal to 90 g/L, neutrophils greater than or equal to 1.5 x 10^9 L, platelets greater than or equal to 100 x 10^9 L;
10. Total bilirubin less than or equal to 1.5 x upper limit of normal;
11. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than or equal to 3 x upper limit of normal;
12. Plasma creatinine less than or equal to 1.5 x upper limit of normal;
13. International Normalized Ratio (INR) and APTT less than or equal to 1.5 x upper limit of normal;
14. Negative urine pregnancy test; and
15. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following the last treatment day.
*except for pharyngeal, laryngeal and tongue base tumours and those tumours in the anterior neck (from posterior border of sternocleidomastoid on each side).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient will be excluded from the study if the patient meets any of the following
criteria:
1. Has treatment with any immunotherapy, biological therapy, or chemotherapy or major surgery within three weeks prior to study treatment (six weeks for nitrosoureas or mitomycin C);
2. Has treatment with any investigational agent for treatment of cancer, other than EBC-46, or related comorbidity within four weeks prior to study treatment or during enrolment in this Protocol;
3. Has had radiation therapy to a visceral organ or tumours within three weeks prior to study treatment;
4. Has known, uncontrolled, CNS metastases;
5. Has a history of significant tumour bleeding in the target (to be treated) tumour(s);
6. Has a target tumour mass(es) immediately adjacent to, or with infiltration into, major arteries, veins or vessels;
7. Patients with a bleeding diathesis or coagulopathy that would make intratumoural injection or biopsy unsafe; patients on therapeutic anticoagulation or anti-platelet agents (such as clopidogrel) are excluded. Prophylactic doses of low molecular weight heparins or low-dose aspirin (less than or equal to 150 mg daily) is allowed;
8. Having not recovered from the toxic effects of previous therapy (Common Terminology Criteria for AEs [CTCAE V4.03] Grade less than or equal to 1) except for fatigue (less than or equal to Grade 2) due to radiation treatment and alopecia;
9. Myocardial infarction, unstable angina pectoris, cerebrovascular accident, pulmonary embolism, uncontrolled congestive heart failure, cardiac arrhythmia (except for controlled atrial fibrillation), arterial thrombosis or transient ischemic attack within the last six months;
10. Significant cardiac comorbidity or poorly controlled hypertension (>150/100 mg Hg) despite optimal medical therapy;
11. Anti-tumour vaccine therapy within six weeks of study treatment;
12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) or other agents used in study;
13. Has uncontrolled disease associated with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection;
14. Patients are pregnant as the effects of EBC-46 on congenital development are unknown;
15. If, in the opinion of the Investigator, the patient is an inappropriate candidate for the study;
16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements;
17. Expected major surgical procedure during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2015
Actual
24/03/2015
Date of last participant enrolment
Anticipated
Actual
19/04/2017
Date of last data collection
Anticipated
Actual
14/06/2017
Sample size
Target
15
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 3122 0
The Alfred - Prahran
Recruitment hospital [2] 3123 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 3124 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 3125 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 8872 0
3004 - Melbourne
Recruitment postcode(s) [2] 8873 0
2170 - Liverpool
Recruitment postcode(s) [3] 8874 0
5042 - Bedford Park
Recruitment postcode(s) [4] 8875 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 8874 0
New Zealand
State/province [1] 8874 0
Mount Cook, Wellington, 6021

Funding & Sponsors
Funding source category [1] 290193 0
Commercial sector/Industry
Name [1] 290193 0
QBiotics Limited
Country [1] 290193 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
QBiotics Limited
Address
7 Penda Street, Yungaburra, Queensland, Australia, 4884
Country
Australia
Secondary sponsor category [1] 288903 0
None
Name [1] 288903 0
Nil
Address [1] 288903 0
Nil
Country [1] 288903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291904 0
The Alfred Health Human Ethics Committee
Ethics committee address [1] 291904 0
Ethics committee country [1] 291904 0
Australia
Date submitted for ethics approval [1] 291904 0
27/10/2014
Approval date [1] 291904 0
12/01/2015
Ethics approval number [1] 291904 0
Ethics committee name [2] 297600 0
Central Health and Disability Ethics Committee
Ethics committee address [2] 297600 0
Ethics committee country [2] 297600 0
New Zealand
Date submitted for ethics approval [2] 297600 0
10/02/2017
Approval date [2] 297600 0
07/03/2017
Ethics approval number [2] 297600 0
Ethics Reference: 17/CEN/28

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52514 0
Dr Jason Lickliter
Address 52514 0
The Nucleus Network, 5th Floor, Burnett Tower, 89 Commercial Road Melbourne, Victoria 3004
Country 52514 0
Australia
Phone 52514 0
+ 61 3 9076 8892
Fax 52514 0
+61 3 9076 8911
Email 52514 0
contactus@nucleusnetwork.com.au
Contact person for public queries
Name 52515 0
Daniel Swart
Address 52515 0
QBiotics Group Limited, 3A/165 Moggill Road, Taringa, Queensland, 4068
Country 52515 0
Australia
Phone 52515 0
+61 7 3870 8933
Fax 52515 0
Email 52515 0
enquiries@qbiotics.com
Contact person for scientific queries
Name 52516 0
Daina Vanags
Address 52516 0
QBiotics Group Limited, 3A/165 Moggill Road, Taringa, Queensland, 4068
Country 52516 0
Australia
Phone 52516 0
+61 7 3870 8933
Fax 52516 0
Email 52516 0
enquiries@qbiotics.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.