Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Toxic and side effect
研究概览
简要总结
This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.
详细描述
Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •progressive advanced metastatic tumors
- •tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
- •adequate renal, haematological, and liver function
- •an Eastern Cooperative Oncology Group performance status of 0-2
排除标准
- •pregnant or lactating women
- •received other radionuclide therapy in the past 6 months
- •received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
研究组 & 干预措施
3.70 GBq (100 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.
干预措施: 3.70 GBq (100 mCi) of 177Lu-JH04 (Drug)
5.55 GBq (150 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04.
干预措施: 5.55 GBq (150 mCi) of 177Lu-JH04 (Drug)
7.40 GBq (200 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04.
干预措施: 7.40 GBq (200 mCi) of 177Lu-JH04 (Drug)
结局指标
主要结局
Toxic and side effect
时间窗: through study completion, an average of 2 weeks
The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
次要结局
- Dosimetry of normal organs and tumors(through study completion, an average of 4 weeks)