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NCT Number: NCT02550678

A Study of the Efficacy and Safety of ASN-002 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.

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Key information

Conditions

Basal Cell Nevus Syndrome Abnormalities, Multiple Bone Cysts Bone Diseases Bone Diseases, Developmental Carcinoma Carcinoma, Basal Cell Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Genetic Diseases, Inborn Jaw Cysts Jaw Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary Nodular Basal Cell Carcinoma of Skin Odontogenic Cysts Skin Diseases Skin Neoplasm Skin Neoplasms Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St George Dermatology and Skin Cancer Centre, Kogarah, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASN-002

Biological

ASN-002, is made of a suspension of recombinant adenoviral particles carrying a gene coding for the human interferon-gamma (IFN). Study participants will receive protocol defined dose of ASN-002 as intra-tumoral injections.

5-FU

Drug

5-FU is chemotherapeutic agent used to treat various cancers.

Primary outcomes

  1. Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC

    Time frame: Participants will be followed up for up to 6 months.

    changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study. Local skin and injection site reactions will be assessed in detail scoring erythema, ulceration, pain and overall severity as none, mild, moderate or severe.

Secondary outcomes

  1. Microscopic clearance of the injected basal cell carcinoma.

    Time frame: Microscopic examinations of sample collected at 17weeks after the first dose.

    Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests in serial histological samples as determined by central pathology review.

  2. Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU

    Time frame: Change in nBCC will be assessed for up to 6 months from the first treatment visit.

    Change in nBCC lesion size will be assessed by investigator at baseline and then every 4 weeks until the surgical excision of BCC after ASN-002 therapy.

Sponsors and collaborators

Lead sponsor

Ascend Biopharmaceuticals Ltd

Industry

Registry information

Official study 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

Acronym: ASN-002-001

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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