CompletedPhase 2ACTRN12615001017516

A Phase I/IIa Study of the Efficacy and Safety of ASN-002 Alone and in Combination with 5-Fluorouracil (5-FU) in Adult Patients with Low-Risk Nodular Basal Cell Carcinoma

Sponsor

Ascend Biopharmaceutical Ltd.

Enrollment

36 participants

Start Date

Sep 21, 2015

Study Type

Interventional

Conditions

Basal Cell Carcinoma Nevus Syndrome Nodular Basal Cell Carcinoma

Summary

The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FUis safe and effective in the treatment of nodular basal cell carcinoma (nBCC). Who is it for? You may be eligible to join this study if you are aged 18 or over, have been diagnosed with nBCC. Study details ASN-002 is a vaccine-like product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body’s own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. 5-FU is a chemotherapeutic agent approved to treat many types of cancer. Participants will attend the study centre weekly for an injection of ASN-002 alone or in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumour. Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study. 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 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

Low risk nodular basal cell carcinoma
Biopsy of any other skin tumor
Willingness to have injection therapy followed by surgery
Written informed consent

Exclusion Criteria9

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 UVA or UVB 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.

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Interventions

Injection of ASN-002 into tumour nodules to stimulate an immune response. The dose depends on the study cohort. Cohort 1: 5 X 10(11) virus particles (vp), weekly injection for 3 weeks. Cohort 2: 1.

Injection of ASN-002 into tumour nodules to stimulate an immune response. The dose depends on the study cohort. Cohort 1: 5 X 10(11) virus particles (vp), weekly injection for 3 weeks. Cohort 2: 1.5X 10(11) vp weekly injection for 3 weeks Cohort 4: 3.0 X 10(11) vp weekly injections for 3 weeks, Cohort 5: 2.25 X 10(11) vp weekly injections for 3 weeks, Only one combination cohort will enrol patients at dose of Cohort 1: 5 X 10(11) virus particles (vp) & 5-FU (5mg) weekly injection for 3 weeks. Note: Cohort 3 required 6 injections, which has been removed in amended protocol. The study drug will be administered by the qualified medical doctor/ dermatologist at the study site. The volume of dose to be administered will depend on the size of the tumor. Tumor size <6 mm: 0.5 mL 6-10mm: 1 mL 11-20mm: 1.5 mL The compliance will be monitored through a dose administration log. Surgical excision of tumor will be performed by a surgeon after 13 weeks follow up from the last study drug dose administered to the study participant. The duration of surgical excision procedure will depend upon the size and location of the tumor.