A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma (ASN-002-001)

Ascend Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: 5-FU; Biological: ASN-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02550678

ASN-002-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 5 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Biological: ASN-002

Cohort 2

Experimental group

Description:

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

Treatment:

Biological: ASN-002

Cohort 4

Experimental group

Description:

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

Treatment:

Biological: ASN-002

Cohort 5

Experimental group

Description:

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

Treatment:

Biological: ASN-002

Combination Cohorts

Experimental group

Description:

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.

Treatment:

Biological: ASN-002

Drug: 5-FU