Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)

Paused · Phase 1/Phase 2

Conditions studied: Basal Cell Carcinoma in Basal Cell Nevus Syndrome

In brief

The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS). The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by 1. evaluating the histological clearance of BCCs in patients with BCNS, and 2. assessing the clinical changes of BCCs after treatment with ASN-002, and 3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions 4. assess the safety and clinical changes after a second cycle of ASN-002 injections

Key facts

Study ID

NCT03208296

Run by

Ascend Biopharmaceuticals Ltd

People needed

24

Starts

2017-12-01

Expected to finish

2025-03-31

Last updated by the study team

2023-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must satisfy established criteria for the diagnosis of BCNS (Section 1.1.2, Table 1).
• Must have at least 4 target lesions, clinically consistent with BCC.
• Up to 6 target lesions, including each of the 3 or 4 to-be-injected lesions and 1 or 2 non-injected lesions must be biopsied.
• At least 3 target lesions, 2 to be injected and one to be non-injected, must be biopsy proven BCC per criteria in Synopsis Table 3: Modified Criteria for Low Risk BCC in BCNS Patients
• Removal of < 25% of the area of the tumor by initial biopsy performed within 12 weeks before screening visit. A 2mm punch biopsy is recommended for histological confirmation of BCC.
• Screening laboratory values as follows:
• Neutrophil count > 1500/mm3
• Hemoglobin > 10 g/dL
• Platelet count > 100,000/mm3
• Total bilirubin < 1.5 X upper limit of normal (ULN), except in the case of known Gilbert's syndrome
• Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) < 1.5X ULN
• Creatinine < 1.5 X upper limit of normal (ULN)
• 18 years of age or older at Screening visit.
• Infertile, postmenopausal, surgically sterile or using acceptable and highly effective birth control methods for the duration of the study and for 3 months after last administration of ASN-002.
• Written informed consent prior to initiation of study-specified procedures.
• Able and willing to comply with all study requirements, including surgical removal of tumor/tumor sites as required by the study.

You may not qualify if…

• Target tumor biopsy shows evidence of:
• micronodular features,
• squamous metaplasia,
• sclerosing BCC,
• morpheic BCC, or
• peri-neural involvement.
• cystic BCC
• Eastern Cooperative Oncology Group (ECOG) performance status > 2.
• Known or suspected metastatic disease.
• Female participants must be non-lactating and non-pregnant.
• Clinically active or uncontrolled skin disease that would interfere with evaluation of the area surrounding the target tumor (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
• Known history of sensitivity to any of the ingredients in ASN-002.
• Immunocompromised (e.g. known hepatitis B or C or HIV infection) or is receiving or is expected to receive an immunomodulating agent (including immunosuppressive agents, cytotoxic drugs, biological agents, immunoglobulins, interferon or other immune or cytokine-based therapies; regular use of inhaled or oral corticosteroids at doses higher than replacement doses is an exclusion criterion).
• Treatment with psoralen plus UVA or UVB therapy within 3 months of screening and agrees not to receive such treatment until excision site is confirmed to be well healed at the post-surgery study visits
• Prior systemic or local treatment for target tumors.
• History of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to any medication.
• Any serious or active medical or psychiatric illness or recreational or therapeutic drug or alcohol use that, in the opinion of the Investigator, would interfere with treatment, assessment or compliance with the protocol, or subject safety.
• Any experimental or investigational agents within 1 month of first injection.
• Any prior exposure to TG1041, TG1042 (ASN-002), any other adenoviral-based experimental agent within 5 months prior to screening visit.

Where it is running

• OHSU — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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