Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor (NCT04416516) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor
Australia21 participantsStarted 2020-07-16
Plain-language summary
The primary objectives are to:
1. Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s;
2. Evaluate the efficacy of intralesional ASN-002 in target tumours when administered in combination with oral vismodegib in patients with BCCs.
The secondary objective is to:
1\) Evaluate the efficacy of intralesional ASN-002 in non-target tumours when administered in combination with oral vismodegib in patients with BCCs.
The exploratory objective is to:
1\) Evaluate immunological biomarkers during the course of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed previously untreated, BCC (nodular and superficial), 5-20 mm in maximum diameter, per the selection criteria for study BCC tumours. A punch biopsy (refer to study procedure manual for biopsy size selection) from the thickest part of all the target tumours is required for histological confirmation of BCC and to exclude BCC non-eligible subtypes.
✓. Removal of \< 25% of the area of each biopsied tumour by initial biopsy performed 1-12 weeks before Day 1. If the initial biopsy was performed \>8 weeks prior to screening, the investigator may re-biopsy the tumour, provided not \> 25% of the area of the original tumour is removed. Non-study tumours may be resected or treated at the discretion of the Investigator prior to study entry or if they develop during the study.
✓. Hedgehog pathway inhibitor treatment naïve.
✓. Acceptable general health as determined by the investigator, i.e. no 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, ability to provide informed consent, or patient safety.
✓. 18 years of age or older.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
✓. Screening laboratory values as follows:
What they're measuring
1
Incidence of ASN-002 related Adverse Events in patients with previously untreated nBCC
Timeframe: Participants will be followed up to 6 months
2
Microscopic clearance of the injected Target basal cell carcinoma.
Timeframe: Microscopic examinations of sample collected at weeks 25-33 after the first dose.
✕. Known or suspected metastatic disease or other active, invasive malignancy.
✕. Female patients of childbearing potential who are lactating or pregnant (negative serum pregnancy test needed prior to dosing).
✕. Clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target tumour (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
✕. Known history of sensitivity to any of the ingredients in ASN-002 and any Hh pathway inhibitors.
✕. Immunocompromised (e.g. known Hepatitis B or C infection, HIV infection) or receiving or expected to receive an immunomodulating agent (including immunosuppressive agents, cytotoxic drugs, biological agents, immunoglobulins, interferon or other immune or cytokine-based therapies. Use of inhaled or oral corticosteroids at doses higher than physiological replacement doses is an exclusion criterion).
✕. Has received or is expected to receive treatment with psoralen plus UVA or UVB therapy within 6 months of the Screening visit.
✕. Any prior systemic anti-tumour therapy or local treatment for target tumours prior to first dose.
✕. 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.