A Phase Ib, Dose Escalation, Multiple Dose Trial With HuMax-IL8 in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of patients who experience DLTs (Dose Limiting Toxicity) 28 days following the first dose of HuMax-IL8, as well as all DLTs occurring during the study thereafter.
研究概览
简要总结
A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.
详细描述
All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
- •Patients may have measurable or non-measurable but evaluable disease.
- •Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
- •Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
- •Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
- •Age ≥ 18 years. .
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
- •Patients must have normal organ and hematologic function therapy
- •Patients must have baseline pulse oximetry > 90% on room air
排除标准
- •Pregnant women or women presently breast-feeding
- •Concurrent treatment for cancer
- •Chronic hepatitis B or C infection.
- •Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
- •Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- •Active autoimmune diseases requiring treatment or a history of autoimmune disease.
- •Concurrent use of systemic steroids
- •Patients who are receiving any other investigational agents
- •Patients with untreated central nervous system metastases or local treatment of brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
- •Serious or uncontrolled intercurrent illness
- •HIV-positive patients are ineligible
- •Patients unwilling to use adequate contraception
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
HuMax-IL8
HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
干预措施: HuMax-IL8 (Drug)
结局指标
主要结局
Proportion of patients who experience DLTs (Dose Limiting Toxicity) 28 days following the first dose of HuMax-IL8, as well as all DLTs occurring during the study thereafter.
时间窗: From cycle 1 day 1 up to 28 days
The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following the first dose of HuMax-IL8
次要结局
- Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve)(From baseline up to 72 hours after infusion)