A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma

NCT ID: NCT02550678

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Basal Cell Nevus Syndrome; Skin Neoplasm; Nodular Basal Cell Carcinoma of Skin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.

Group Type: EXPERIMENTAL

ASN-002

Intervention Type: 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.

Cohort 2

Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks

Group Type: EXPERIMENTAL

ASN-002

Intervention Type: 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.

Cohort 4

Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Group Type: EXPERIMENTAL

ASN-002

Intervention Type: 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.

Cohort 5

Study Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Group Type: EXPERIMENTAL

ASN-002

Intervention Type: 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.

Combination Cohorts

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.

Group Type: EXPERIMENTAL

ASN-002

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

ASN-002

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.

Intervention Type: BIOLOGICAL

5-FU

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Low risk nodular basal cell carcinoma

2. Biopsy of any other skin tumor

3. Willingness to have injection therapy followed by surgery

4. Written informed consent

Exclusion Criteria

1. No or only minimal symptoms

2. Known or suspected metastatic disease.

3. Pregnant or Lactating females

4. Clinically active or uncontrolled skin disease

5. Immunocompromised or receiving immunomodulating agent

6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months

7. Any serious or active medical or psychiatric illness

8. Recreational or therapeutic drug or alcohol use

9. Taking any investigational product within 1 month of first dose of ASN- 002.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascend Biopharmaceuticals Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynda Spelman

Role: PRINCIPAL_INVESTIGATOR

Veracity Clinical Research Pty Ltd.

Rodney Sinclair

Role: PRINCIPAL_INVESTIGATOR

Sinclair Dermatology Pty Ltd

Gregory Siller

Role: PRINCIPAL_INVESTIGATOR

Siller Medical T/A Central Brisbane Dermatology

Locations

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, Australia

Siller Medical T/A Central Brisbane Dermatology

Brisbane, Queensland, Australia

Veracity Clinical Research

Brisbane, Queensland, Australia

Sinclair Dermatology

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

ASN-002-001

Identifier Type: -

Identifier Source: org_study_id