NCT07161310招募中不适用
A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Goethe University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年1月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the composition of circulating lymphocytes
研究概览
简要总结
The aim of this clinical study is to learn more about the effects of urolithin A (MitoPure®) on the immune system of cancer patients receiving immune checkpoint inhibitor-based therapies. Any effects will be compared with patients who take a placebo instead of urolithin A (MitoPure®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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 solid cancer without previous systemic anticancer treatment
- •Planned single agent or double agent immune checkpoint inhibitor therapy as first-line standard-of-care treatment either with or without chemotherapy. Of note, patients receiving neoadjuvant therapy are eligible
- •Age ≥ 18 years
- •Life-expectancy ≥ 3 months
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits and scheduled follow-up visits and examinations
- •Female patients of childbearing potential (WOCBP) are only eligible if using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:
- •Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- •Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
- •Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
排除标准
- •Patients who currently receive or have received cytostatic chemotherapy, glucocorticoids, or immune modulatory agents (including low-dose methotrexate, TNF alpha inhibitors, calcineurin inhibitors, interleukin inhibitors, etc.) during the last 3 months are not eligible. Of note, topical glucocorticoid treatments and hormone replacement therapy is acceptable
- •Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine
- •Patients who have received radiotherapy to the mediastinum or to other areas with anticipated strong irradiation of a large blood vessel by the judgement of the investigator are not eligible
- •Patients with known HIV infection are not eligible. Testing is not mandatory
- •Patients with a history of solid organ or hematopoietic cell transplantation
- •Any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the patient
研究组 & 干预措施
Urolithin A
Active Comparator
干预措施: Bio specimens (Other)
Urolithin A
Active Comparator
干预措施: Urolithin A (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Bio specimens (Other)
结局指标
主要结局
Change in the composition of circulating lymphocytes
时间窗: From enrollment to the end of urolithin A intake at 8-9 weeks
次要结局
- Changes in the plasma cytokine profile(From enrollment to the end of urolithin A intake at 8-9 weeks)
- Transcriptional changes in immune cells(From enrollment to the end of urolithin A intake at 8-9 weeks)
研究者
Fabian Acker
Coordinating investigator
Goethe University
研究点 (1)
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