Basal Cell Nevus Syndrome Clinical Trial
Official title:
A Phase 1/2a Study of the Efficacy and Safety of ASN-002 Alone or in Combination With 5-FU in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal
cell carcinoma (nBCC) in patients aged 18 years or over.
The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU
for 3 weeks and undergo surgical excision of the tumor.
The primary purpose of this study is to determine whether ASN-002 alone or in combination
with 5-FU is safe and effective in the treatment of nodular basal cell carcinoma (nBCC).
Patients aged 18 or over, who have been diagnosed with nodular Basal Cell Carcinoma (nBCC),
may be eligible to join this study.
Study details:
ASN-002 is an immunotherapeutic 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. Participants will attend the study centre weekly for an
injection of ASN-002 alone of 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
tumor.
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 or in combination with 5-FU for nBCC, particularly for
patients in whom the standard treatment of surgery is not possible or not recommended.
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