A Phase IIa Study to assess the Efficacy and Safety of ASN-002 alone and in combination with chemotherapy in adult participants with Low-Risk Basal Cell Carcinomas

Phase 2

• Conditions: Basal Cell Carcinoma; Basal Cell Nevus Syndrome (BCNS); Cancer - Non melanoma skin cancer; Skin - Other skin conditions

• Registration Number: ACTRN12619001298101
• Lead Sponsor: Ascend Biopharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-20
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Histologically confirmed low risk nodular and/or superficial basal cell carcinoma 6-20mm in diameter;
Acceptable general health;
Willingness to have injection therapy followed by surgery;
Written informed consent
To be eligible, participants must have from 1 to 5 BCCs.

Exclusion Criteria

No or only minimal symptoms;
Known or suspected metastatic disease;
Pregnant or Lactating females;
Clinically active or uncontrolled skin disease;
Known sensitivity to ingredients in ASN-002 or chemotherapeutic agent
Immunocompromised or receiving immunomodulating agent;
Treatment with psoralen plus UVA or UVB therapy within 6 months of the screening visit;
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;
History of any immunological disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of ASN-002 injected in combination with chemotherapeutic agent as assessed by examination of changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study as well as local skin and injection site responses and inflammation.[Weeks 2, 3, 4, 17 and 24 post first dose. Phone call follow up on day 2 and 3 post each ASN-002 injection.];Safety and Tolerability of ASN-002 injected into 2-5 previously untreated BCCs as assessed by examination of changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study as well as local skin and injection site responses and inflammation.[Weeks 2, 3, 4, 17 and 24 post first dose. Phone call follow up on day 2 and 3 post each ASN-002 injection.]

Secondary Outcome Measures

Name	Time	Method
Evaluate the histological clearance of injected BCCs by histopathology.[Tumours are resected 24 weeks after commencement of intervention. Tumours are assessed by microscopic examination and compared histopathogically to biopsies collected prior to commencement of therapy.]