An Intra-patient Placebo-controlled, Phase I Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 (Heat-killed Mycobacterium Obuense) in Adult Melanoma Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
详细描述
The proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate the safety and tolerability of three different doses of IMM-101 administered intradermally to melanoma patients. Additionally, the study aims to characterize local responses to this vaccine in order to delineate unexpected / unacceptable local reactions from those indicative of appropriate immunological response in this patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
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
- •confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment
- •willing to use effective contraception for the duration of the study
- •able to comply with the requirement to complete a diary card
排除标准
- •Pregnant or lactating females
- •Major surgery within the 14 days preceding the screening visit
- •Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis
- •Treatment with another investigational medicinal product within the last 30 days prior to the screening visit
- •Previous treatment with M. vaccae
- •Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months
- •Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system
- •Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit
- •Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
研究组 & 干预措施
IMM-101
Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:
'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
干预措施: Heat killed whole cell M. obuense (IMM-101) 0.1 mg (Biological)
IMM-101
Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:
'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
干预措施: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg (Biological)
IMM-101
Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:
'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
干预措施: Heat killed whole cell M.obuense (IMM-101) 1.0 mg (Biological)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 56 days
Safety and tolerability were measured with respect to: 1. Safety measurements 2. Local tolerability at the site of intradermal injection 3. Incidence of adverse events.
次要结局
- Administration Site Reactions(Day -3 to Day 56)