None listed
Conditions
Brief summary
This clinical trial is assessing the safety and efficacy of a modified virus (ASN-002) to treat low risk basal cell carcinoma skin cancer alone or in combination with a chemotherapeutic agent. Who is it for? You may be eligible join this study if you are aged 18 years or more and have at least one histologically confirmed low risk nodular and/or superficial basal cell carcinoma of 6-20mm in diameter, and are in acceptable general health. Trial details This study is conducted in two parts. Participants in Part A will be administered the modified virus (ASN-002) in combination with a chemotherapeutic agent (at one of 3 different doses). Both agents will be injected directly into the same skin cancer lesion once a week for 3 weeks. Participants in Part B will receive ASN-002 only (without a chemotherapeutic agent) into one or multiple lesions once weekly for 3 weeks. All participants will have the skin cancers surgically removed approximately 5 months after the injections. Participants will be assessed in clinic and by telephone for up to 24 weeks in order to monitor safety and tolerability of treatments. The cancers will also be measured and photographed to see how they respond to treatment. It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone and in combination with a chemotherapeutic agent for BCC.
Interventions
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 45m
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.
Sponsors
Ascend Biopharmaceuticals Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed