An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.
详细描述
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent document.
- •Age 18 and older.
- •Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- •Progressive disease after multiple-lines treatment.
- •Eastern Cooperative Oncology Group Performance Status ≤
- •Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-RGD PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-RGD study and completion of the scan.
- •Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.
- •Blood chemistry levels defined as AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan.
排除标准
- •Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
- •Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- •Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
- •Pregnant or lactating women.
- •Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks.
- •Has an additional active malignancy requiring therapy within the past 2 years.
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •Psychiatric illness/social situations that would interfere with compliance with study requirements
- •Cannot undergo PET/CT scanning because of weight limits (350 lbs).
- •INR>1.2; PTT>5 seconds above UNL.
研究组 & 干预措施
177Lu-AB-3PRGD2
177Lu-AB-3PRGD2 A maximum of 4 cycles of 80 mCi (2.96 GBq) 177Lu-AB-3PRGD2, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks
干预措施: 177Lu-AB-3PRGD2 radioligand therapy (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At the end of Cycle 4 (each cycle is 42 days)
68Ga-RGD will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-RGD will be performed at baseline, and 6 weeks after two treatment cycles.
次要结局
- Incidence of treatment-related adverse events (safety and tolerability)(At the end of Cycle 4 (each cycle is 42 days))