NCT04053283已完成1 期
A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Akamis Bio
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Incidence of adverse events (safety and tolerability) in study NG-641
研究概览
简要总结
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
详细描述
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 or cytologically documented metastatic or advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available
- •All patients
- •Provide written informed consent to participate
- •At least one measurable site of disease according to RECIST Version 1.1 criteria
- •Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
- •Ability to comply with study procedures in the Investigator's opinion
- •Aged 18 years or over
- •ECOG performance status 0 or 1
- •Predicted life expectancy of 6 months or more
- •Adequate lung reserve
- •Adequate renal function
- •Adequate hepatic function
- •Adequate bone marrow function
- •Meeting reproductive status requirements
排除标准
- •Prior or planned allogenic or autologous bone marrow or organ transplantation
- •Splenectomy
- •Active infections requiring antibiotics, physician monitoring or systemic therapy within 1 week of the anticipated first dose of study drug, or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
- •Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment
- •Known history of hepatitis B infection or known active hepatitis C infection. Known history of HIV infection
- •Patients who have active, known or suspected autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving systemic immunosuppressive treatment
- •Treatment with any live, live-attenuated or COVID-19 vaccine in the 28 days before the first dose of NG-641
- •Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641
- •History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
- •History of clinically significant interstitial lung disease or non-infectious pneumonitis
- •Lymphangitic carcinomatosis
- •Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
- •Any known CTCAE Grade ≥2 coagulation abnormality/coagulopathy
- •Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the 6 months before the first dose of study treatment
- •Grade 3 or 4 gastrointestinal bleeding All toxicities attributed to prior anti-cancer therapy (including radiation therapy) other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment
- •Tumour location/extent considered by the Investigator to present a significant risk if tumour flare or necrosis were to occur
- •Known retinopathy, including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction
- •Active clinically severe depression
- •Use of following prior therapies
- •Enadenotucirev-based therapy, or a fibroblast activation protein (FAP) targeting agent anytime
- •Anti-cancer monoclonal antibody (mAb), immune checkpoint inhibitor, immune stimulatory treatment or other biological therapy in the 28 days prior to the first dose of study treatment (PD-1 / PD-L1 therapy permitted without a 'washout' phase)
- •Chemotherapy, targeted small molecule or other investigational drug in the 14 days or five half-lives (whichever is shorter) before the first dose of study treatment
- •Major surgery in the 28 days before the first dose of study treatment or radiation therapy in the 14 days before the first dose of study treatment
- •Bisphosphonate therapy or treatment with Receptor Activator of Nuclear factor Kappa-Β (RANK)-ligand inhibitors for metastatic bone disease is permitted
- •All toxicities attributed to prior anti-cancer therapy (including radiation therapy) other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment
- •Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
- •Known hypersensitivity to both cidofovir and valacyclovir
- •Other prior malignancy active within the previous 3 years (see protocol for exceptions)
- •Symptomatic brain metastases or any leptomeningeal metastases that are symptomatic and/or requires treatment
- •Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
研究组 & 干预措施
Intravenous
Experimental
Phase 1a dose escalation: one cycle of treatment.
Phase 1a dose optimisation: up to 8 cycles of treatment
干预措施: NG-641 (Biological)
结局指标
主要结局
Incidence of adverse events (safety and tolerability) in study NG-641
时间窗: End of study treatment visit
Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
次要结局
未报告次要终点
研究者
研究点 (6)
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