NCT06182579终止1 期
Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Determination of Recommended Dose
研究概览
简要总结
This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.
详细描述
Primary Objectives:
• To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5
Secondary Objectives:
- To determine clinical response of RiMO-401 with palliative radiotherapy
- To characterize adverse events of RiMO-401 in patients with advanced cancers
- To characterize the pharmacokinetics of RiMO-401 with palliative radiation
The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.
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
- •Diagnosis of advanced or metastatic cancer not amenable to curative therapy
- •Lesion that is amenable to palliative radiotherapy
- •Lesion that is technically feasible for intratumoral injection
- •Target tumor in region not in the field that was irradiated within the past six months
- •Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment
- •Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment
- •Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
- •ECOG score of 0-1
- •Have a life expectancy of at least 12 weeks
- •Have adequate bone marrow reserve and adequate liver function
- •Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures
- •Patients must sign a study-specific informed consent form prior to study entry
- •Age 18 years or older.
排除标准
- •Patients with a histological diagnosis of lymphomas and/or leukemias
- •Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected
- •Patients may not have received chemotherapy, targeted therapies, immunotherapies, 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
- •Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.
研究组 & 干预措施
RiMO-401
Experimental
• Single intratumoral injection followed by radiation
干预措施: RiMO-401 (Drug)
结局指标
主要结局
Determination of Recommended Dose
时间窗: 45 Days
The dose limiting toxicities of RiMO-401 with palliative radiation, as assessed by CTCAEv5, will not be observed in 33% or more patients
次要结局
- Evaluation of Safety and Tolerability(45 Days)
- Evaluation of Objective Response Rate (ORR)(45 Days)
研究者
研究点 (1)
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