Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001298101
Ethics application status
Approved
Date submitted
29/08/2019
Date registered
20/09/2019
Date last updated
20/09/2019
Date data sharing statement initially provided
20/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase IIa Study to assess the Efficacy and Safety of ASN-002 alone and in combination with chemotherapy in adult participants with Low-Risk Basal Cell Carcinomas
Scientific title
A Phase IIa Study to assess the Efficacy and Safety of ASN-002 alone and in combination with chemotherapy in adult participants with Low-Risk Basal Cell Carcinomas
Secondary ID [1] 298983 0
SP-002
Universal Trial Number (UTN)
U1111-1238-4109
Trial acronym
ASN-002-IL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 313974 0
Basal Cell Nevus Syndrome (BCNS) 313975 0
Condition category
Condition code
Cancer 312374 312374 0 0
Non melanoma skin cancer
Skin 312375 312375 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A
ASN-002 and 5-fluorouracil (5-FU) to be administered as separate intratumoral injections into the same target lesion on the same day.
Arm 1: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] in addition to 5mg chemotherapeutic agent weekly for 3 weeks [cumulative dose 15mg]
Arm 2: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] in addition to 15mg chemotherapeutic agent weekly for 3 weeks [cumulative dose 45mg]
Arm 3: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] in addition to 25mg chemotherapeutic agent weekly for 3 weeks [cumulative dose 75mg]

Part B
ASN-002 to be injected intratumorally into the same target lesion on 3 occasions.
Arm 1: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] split between 2 or 3 lesions
Arm 2: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] split between 4 lesions
Arm 3: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] split between 5 lesions
Arm 4: 1.5 X 10(11) ASN-002 viral particles per week for 3 weeks [cumulative dose 4.5 x 10(11)] injected into a single lesion

Participants will only be recruited into one of the study arms. Participants with a single lesion will be recruited into either Part A; Arm 1, 2 or 3 or Arm 4 of Part B. Participants with 2 or more lesions will be recruited into Part B; Arms 1, 2 or 3. For participants in Part B Arms 1, 2 and 3, doses of ASN-002 are split evenly between lesions.
Fidelity of the treatment schedule will be directly via the Principle Investigator who will inject all lesions.
Intervention code [1] 315278 0
Treatment: Drugs
Comparator / control treatment
Part B Arm 4 is the control arm for Part A.
Control group
Active

Outcomes
Primary outcome [1] 321057 0
Safety and Tolerability of ASN-002 injected in combination with chemotherapeutic agent as assessed by examination of changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study as well as local skin and injection site responses and inflammation.
Timepoint [1] 321057 0
Weeks 2, 3, 4, 17 and 24 post first dose. Phone call follow up on day 2 and 3 post each ASN-002 injection.
Primary outcome [2] 321058 0
Safety and Tolerability of ASN-002 injected into 2-5 previously untreated BCCs as assessed by examination of changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study as well as local skin and injection site responses and inflammation.
Timepoint [2] 321058 0
Weeks 2, 3, 4, 17 and 24 post first dose. Phone call follow up on day 2 and 3 post each ASN-002 injection.
Secondary outcome [1] 373831 0
Evaluate the histological clearance of injected BCCs by histopathology.
Timepoint [1] 373831 0
Tumours are resected 24 weeks after commencement of intervention. Tumours are assessed by microscopic examination and compared histopathogically to biopsies collected prior to commencement of therapy.

Eligibility
Key inclusion criteria
Histologically confirmed low risk nodular and/or superficial basal cell carcinoma 6-20mm in diameter;
Acceptable general health;
Willingness to have injection therapy followed by surgery;
Written informed consent
To be eligible, participants must have from 1 to 5 BCCs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No or only minimal symptoms;
Known or suspected metastatic disease;
Pregnant or Lactating females;
Clinically active or uncontrolled skin disease;
Known sensitivity to ingredients in ASN-002 or chemotherapeutic agent
Immunocompromised or receiving immunomodulating agent;
Treatment with psoralen plus UVA or UVB therapy within 6 months of the screening visit;
Any serious or active medical or psychiatric illness;
Recreational or therapeutic drug or alcohol use;
Taking any investigational product within 1 month of first dose of ASN-002;
History of any immunological disorder

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)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Investigator may enrol eligible participants into either Part A or B. In Part A, three combination Arms will receive a low (5mg), intermediate (15mg) and high dose (25mg) of chemotherapeutic agent per injection weekly for 3 weeks, i.e. total cumulative dose of 15 mg, 45 mg and 75 mg respectively. The high dose Arm will only be enrolled if the low and intermediate doses show acceptable safety and tolerability. The high dose Arm will be enrolled at the discretion of the Investigator.
Eligible participants will be enrolled sequentially in the low and intermediate dose Arms or as decided by the Investigator based on clinical presentation.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an early phase study. The number of participants to be treated in each arm has been determined arbitrarily by the Investigator and Sponsor based on results in previous studies.
All data will be provided in data listings sorted by Study Arm and participant number. Categorical data, including clinical and histological responses for injected and any non-injected lesions, will be summarised by the number and percent of participants falling in each category. Continuous variables will be summarised by descriptive statistics including mean, standard deviation, median, minimum, and maximum.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14559 0
Siller Medical - Central Brisbane Dermatology - Brisbane
Recruitment postcode(s) [1] 27574 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 303567 0
Commercial sector/Industry
Name [1] 303567 0
Ascend Biopharmaceuticals Ltd
Country [1] 303567 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascend Biopharmaceuticals Ltd
Address
Level 1, 159 Dorcas Street
South Melbourne, VIC 3205
Country
Australia
Secondary sponsor category [1] 303646 0
Commercial sector/Industry
Name [1] 303646 0
Stamford Pharmaceuticals Inc
Address [1] 303646 0
Level 2, 330 Railroad Avenue
Greenwich, CT 06830
Country [1] 303646 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304100 0
Metro South HREC
Ethics committee address [1] 304100 0
Ethics committee country [1] 304100 0
Australia
Date submitted for ethics approval [1] 304100 0
24/04/2019
Approval date [1] 304100 0
17/07/2019
Ethics approval number [1] 304100 0
HREC/2019/QMS/53826

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

Contacts
Principal investigator
Name 59658 0
Dr Gregory Siller
Address 59658 0
Central Brisbane Dermatology, 101 Wickham Tc, Brisbane QLD 4000
Country 59658 0
Australia
Phone 59658 0
+61 7 3831 4382
Fax 59658 0
+61 7 3831 4387
Email 59658 0
[email protected]
Contact person for public queries
Name 59659 0
Gregory Siller
Address 59659 0
Central Brisbane Dermatology, 101 Wickham Tc, Brisbane QLD 4000
Country 59659 0
Australia
Phone 59659 0
+61 7 3831 4382
Fax 59659 0
+61 7 3831 4387
Email 59659 0
[email protected]
Contact person for scientific queries
Name 59660 0
Clement Leong
Address 59660 0
Ascend Biopharmaceuticals Ltd
Level 1, 159 Dorcas Street South Melbourne VIC 3205
Country 59660 0
Australia
Phone 59660 0
+61 3 8606 3400
Fax 59660 0
+61 3 9686 9866
Email 59660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD collected during the trial will be retained by the investigator and site personnel only. Anonymised data will be used in publications and for reporting to the Sponsor only as per routine ICH GCP.


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.