NCT06197139招募中1 期
A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of [177Lu]Lu-XT117 Injection in FAP-positive Patients With Advanced Solid Tumors
Xinlu Wang1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-XT117 injection in patients with FAP-positive advanced solid tumors.
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
- •≥18 years old
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
- •Confirmed as malignant solid tumor by histopathology
- •Have measurable lesions based on RECIST 1.1
- •Have failed standard treatment (disease progression or intolerance) or lack standard treatment
- •Positive FAP expression confirmed by FAP PET/CT
- •Sufficient bone marrow capacity and organ function
排除标准
- •High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for [177Lu]Lu-XT117 therapy by the investigators
- •Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy
- •Uncontrolled diabetes, with baseline fasting blood glucose > 2×ULN
- •Clinically significant serious cardiovascular disease, including but not limited to: a. >Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension [CTCAE5.0] with hypotensor are allowed for enrollment); e. QTc>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT
- •Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug
- •Major surgery within 4 weeks prior to the initial administration of the study drug
- •History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration
- •Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment
- •History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function
- •Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)
- •Primary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:
- •Subjects with asymptomatic brain metastases;
- •Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled;
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
研究组 & 干预措施
[177Lu]Lu-XT117 treatment
Experimental
干预措施: [177Lu]Lu-XT117 (Drug)
结局指标
主要结局
Treatment emergent adverse events
时间窗: Until 6 months after the last administration
Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.
次要结局
- Disease Control Rate (DCR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
- Overall Response Rate (ORR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
- Duration of Response (DOR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
- Radiation dosimetry of [177Lu]Lu-XT117 to whole body, lesions, organs, and selected regions of interest(1、4、24、48、72 and 168 hours after first administration)
- Progression Free Survival (PFS)(Every 6 weeks after first administration until disease progression or death or through study completion, assessed up to 2 years)
- Overall Survival (OS)(Every 6 weeks after first administration until death, assessed up to 2 years)
研究者
Xinlu Wang
Chief of Nuclear Medicine Department
The First Affiliated Hospital of Guangzhou Medical University
研究点 (1)
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