NCT04830592已完成1 期
A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck
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
- 36
- 试验地点
- 4
- 主要终点
- Incidence of adverse events (safety and tolerability)
研究概览
简要总结
A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).
详细描述
Part A (NG-641 monotherapy): Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A. Patients will then proceed to planned surgical resection.
Part B (NG-641 and pembrolizumab): Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab. Patients will then proceed to planned surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Newly diagnosed or recurrence of clinical stage III-IVb, histologically confirmed oral cavity, larynx, hypopharynx or oropharynx SCCHN (T1 with N2-3; T2 with N2-3; T3 with N0-3; T4a with N0-3)
- •Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery (potential for 2-3 cm of resected tumour specimen to be available for translational research purposes)
- •Provide written informed consent to participate
- •Aged 18 years or over
- •Willing to consent to tumour biopsies at baseline
- •ECOG performance status 0 or 1
- •Ability to comply with study procedures in the Investigator's opinion
- •Adequate renal function
- •Adequate hepatic function
- •Adequate bone marrow function
- •Meeting reproductive status requirements
排除标准
- •Prior allogeneic or autologous bone marrow or organ transplantation
- •Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection. Active infection requiring systemic therapy within 1 week of the anticipated first dose of study drug
- •Active viral disease or positive test for hepatitis B virus, hepatitis C virus (HCV) or HIV/AIDS
- •Patients who have active 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 (see protocol for full criteria)
- •Treatment with any COVID-19 vaccine in the 28 days before the first dose of NG-641, unless the vaccine is known to not be based on an adenoviral vector (e.g., mRNA vaccines)
- •Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-641
- •History of clinically significant chronic liver disease
- •History of clinically significant interstitial lung disease (including pneumonitis)
- •History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
- •Use of antiviral agents
- •Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
- •Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding or risk factors for gastrointestinal bleeding, infectious or inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event, history or evidence of haemoptysis, or significant cardiovascular or cerebrovascular event
- •Any known Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy
- •Prior history of bowel obstruction, or infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
- •Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational drug/therapy in the 28 days before the first dose of study treatment:
- •All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment. Patients with toxicities (other than renal toxicities) attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enrol
- •Other prior malignancy active within the previous 3 years
- •Tumour location/extent considered by the Investigator to present a significant risk of airway obstruction if tumour flare or necrosis were to occur
- •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
- •Previous treatment with any other enadenotucirev-based therapy, or fibroblast activation protein (FAP) targeting agent
- •Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
- •Any other medical or psychological condition that would affect the patient's ability to comply with all visits and assessments, or compromise ability to give informed consent
- •Related to or a dependent of the site staff, or a member of the site staff.
研究组 & 干预措施
Part A
Experimental
NG-641 monotherapy
干预措施: NG-641 (Biological)
Part B
Experimental
NG-641 and pembrolizumab
干预措施: NG-641 (Biological)
Part B
Experimental
NG-641 and pembrolizumab
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Incidence of adverse events (safety and tolerability)
时间窗: End of Study Treatment Visit (Day 57)
Assess the safety and tolerability of NG-641 by review of adverse events (AEs), serious adverse events, AEs resulting in delays to planned surgery, AEs leading to study treatment or study discontinuation and AEs resulting in death.
次要结局
未报告次要终点
研究者
研究点 (4)
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