NCT04416516已完成2 期
A Phase 2A Study to Assess the Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor in the Treatment of Multiple Low Risk Basal Cell Carcinomas in Sporadic or Basal Cell Nevus Syndrome Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 13
- 主要终点
- Incidence of ASN-002 related Adverse Events in patients with previously untreated nBCC
研究概览
简要总结
The primary objectives are to:
- Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s;
- 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:
- 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:
- Evaluate immunological biomarkers during the course of treatment.
详细描述
Methodology:
This study will evaluate ASN-002 (in the dose range 0.5 to 1.5x10(11) vp/mL) with the Hh inhibitor vismodegib (Erivedge®). The study will initially evaluate two Arms receiving 1.0 x 10(11) vp/injection, and following a safety review, may implement further arms in an adaptive study design.
Following screening and baseline biopsies for target and non-target tumours, eligible subjects will be enrolled in the study.
Cycle 1: Treatment with vismodegib (daily dose of 150 mg) for 4 weeks and ASN-002 for 3 weeks (i.e., three ASN-002 injections in total):
- Day 1 to Day 14 - vismodegib alone
- Day 15 - vismodegib and ASN-002
- Day 16 to Day 21 - vismodegib alone
- Day 22 - vismodegib and ASN-002
- Day 23 to Day 28 - vismodegib alone
- Day 29 - ASN-002 alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Note: If a patient has mix of nodular and superficial BCC tumours, at least one target tumour should be a nodular BCC.
- •Removal of < 25% of the area of each biopsied tumour by initial biopsy performed 1-12 weeks before Day
- •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
- •Screening laboratory values as follows:
- •Neutrophil count > 1500/mm3
- •Haemoglobin > 9 g/dL
- •Platelet count >100,000/mm3
- •Prothrombin INR < 1.5
- •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) < 2X ULN
- •Creatinine < 1.5 X upper limit of normal (ULN)
- •Female patients who are documented infertile, postmenopausal for at least 1 year, surgically sterile or using acceptable and highly effective birth control for the duration of the study and for at least 3 months after last administration of the study treatments.
- •Male patients with female partners of child bearing potential, agreement to use two adequate contraception methods while being on vismodegib and for 3 months of completion. agreement not to donate semen for 3 months after completion of vismodegib.
- •Written informed consent prior to initiation of study-specified procedures.
- •Able and willing to comply with all study requirements, including surgical removal of tumour/tumour site at completion of study.
- •Baseline tissue sample adequate for determination of histological or other biomarkers.
- •Exclusion Criteria
- •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.
- •Any experimental or investigational agents within one month of first ASN-002 injection.
- •Any prior exposure to TG1041, TG1042 (ASN-002), any other adenoviral-based experimental agent, or any form of gene therapy within 6 months of first dose of vismodegib in the study.
- •Any prior exposure to vismodegib or any other Hh inhibitor within 6 months of first dose in the study.
- •Current therapy with any medications recognized to cause rhabdomyolysis or a prior history of rhabdomyolysis.
排除标准
- 未提供
结局指标
主要结局
Incidence of ASN-002 related Adverse Events in patients with previously untreated nBCC
时间窗: Participants will be followed up to 6 months
Incidence of Adverse Adverse events will be monitored
Microscopic clearance of the injected Target basal cell carcinoma.
时间窗: Microscopic examinations of sample collected at weeks 25-33 after the first dose.
Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests in serial histological samples as determined by central pathology review.
次要结局
- Microscopic clearance of the injected Non-Target basal cell carcinoma.(Microscopic examinations of sample collected at weeks 25-33 after the first dose.)
研究者
研究点 (13)
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