A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma (ASN-002-001)
Basal Cell Nevus Syndrome, Skin Neoplasm, Nodular Basal Cell Carcinoma of Skin
About this trial
This is an interventional treatment trial for Basal Cell Nevus Syndrome focused on measuring Untreated nBCC, Low-Risk
Eligibility Criteria
Inclusion Criteria:
- Low risk nodular basal cell carcinoma
- Biopsy of any other skin tumor
- Willingness to have injection therapy followed by surgery
- Written informed consent
Exclusion Criteria:
- No or only minimal symptoms
- Known or suspected metastatic disease.
- Pregnant or Lactating females
- Clinically active or uncontrolled skin disease
- Immunocompromised or receiving immunomodulating agent
- treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months
- 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.
Sites / Locations
- St George Dermatology and Skin Cancer Centre
- Siller Medical T/A Central Brisbane Dermatology
- Veracity Clinical Research
- Sinclair Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 4
Cohort 5
Combination Cohorts
Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.
Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks
Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Study Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Study Participants will receive ASN- 002 at either dose of Cohorts II, IV or V in combination with a low dose 5-FU (1mg/2.5 mg/5mg/10mg or 25mg) weekly injections in tumor nodules for 3 weeks.