Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes.
Condition or Disease:
Patient with advanced tumor which is clinically accessible for intratumoral injection
Intervention/Treatment:
Drug - RiMO-301
Radiation - Radiotherapy
Phase:
Phase 1
详细描述
Primary Objectives:
• The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses
Secondary Objectives:
- To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief
- To characterize adverse events of RiMO-301 in patients with advanced cancers
- To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation
The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment:
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
- •Diagnosis of advanced or metastatic cancer not amenable to curative therapy
- •Lesion that is amenable to palliative radiotherapy
- •Lesion that is technically feasible to irradiation and accessible for direct intratumoral injection
- •Target tumor in region not in previously irradiated field
- •Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment
- •Age >18 years
- •Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
- •Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing
- •Patients must sign a study-specific informed consent form prior to study entry
排除标准
- •Patients with a histological diagnosis of lymphomas and/or leukemias
- •Patients may not have received chemotherapy, targeted therapies, biologic response modifiers and/or hormonal therapy within the last 14 days
- •Ongoing clinically significant infection at or near the incident lesion
- •Major surgery over the target area (excluding placement of vascular access) <21 days from beginning of the study drug or minor surgical procedures <7 days
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
- •Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
- •Pregnant and nursing women
- •Patients with a target lesion located in a previously irradiated field
研究组 & 干预措施
RiMO-301+Radiotherapy
3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study
干预措施: RiMO-301 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 45 days
• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy
次要结局
- Area Under the Curve [AUC](45 days)
- clinical benefit(45 days)
- adverse effect(45 days)
- Maximum Plasma Concentration [Cmax](45 days)