A Phase 1a, Multi-centre, Open-label, Non-randomized Study to Assess the Safety, Biodistribution and Tumour Uptake of [I-124]-CPD-1028 Injection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Obtain preliminary biodistribution data for [I-124]-CPD-1028
研究概览
简要总结
The purpose of the study is to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in cancer patients with solid tumours.
详细描述
Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥18 years old with life expectancy > 12 weeks with confirmed metastatic or unresectable malignancy
- •Patients must have progressed after at least first-line chemotherapy and have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or
- •All patients must have archival tumour samples available and must have verification of IGF-1R expression.
- •Patients must have adequate organ and marrow function, vital signs and ECG.
- •Females of childbearing potential must not be pregnant and both males and females must use adequate forms of contraception.
- •Signed informed consent form
- •Subject must be compliant and have a high probability of completing the study.
排除标准
- •Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from previous treatment.
- •Patients who have received a therapeutic radiopharmaceutical in the past year or who are currently receiving any other investigational agents.
- •Previous treatment with IGF-1R inhibitors.
- •Patients who are currently taking antithyroid medications and lithium or potassium sparing diuretics.
- •Subjects with known or suspected allergies or contraindications to the investigational agents and iodine
- •Subjects with uncontrolled intercurrent illness
- •Female subjects who are pregnant, planning to become pregnant or are lactating and/or breast-feeding.
- •Patients with diabetes requiring therapy unless controlled through diet or metformin.
- •Subjects who are undergoing monitoring of occupational ionising radiation exposure.
- •Subjects with hypothyroidism requiring thyroid supplementation
研究组 & 干预措施
[I-124]-CPD-1028 PET/CT
Administration of [I-124]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions.
A pre-targeting dose of CPD-1061 may be given prior to injection of [I-124]-CPD-1028.
干预措施: [I-124]-CPD-1028 Injection (Drug)
[I-124]-CPD-1028 PET/CT
Administration of [I-124]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions.
A pre-targeting dose of CPD-1061 may be given prior to injection of [I-124]-CPD-1028.
干预措施: CPD-1061 (Biological)
结局指标
主要结局
Obtain preliminary biodistribution data for [I-124]-CPD-1028
时间窗: Up to 18 days
Biodistribution data will be assessed by quantitative analysis of imaging scans taken 2-3 days and 5-7 days post injection by (1) measuring tumour uptake and background tissue levels in selected regions of interest on whole body images and (2) determining if suitable quantitative imaging metrics can be identified.
Evaluate safety of [I-124]-CPD-1028 Injection
时间窗: Up to 30 days
The safety of \[I-124\]-CPD-1028 Injection will be assessed for up to 30 days post injection by measuring the occurrence of adverse events and changes from baseline in physical examination, clinical laboratory parameters, electrocardiogram recordings, and vital signs (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation).
次要结局
- Measure blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-Iodide(Up to 18 days)
- Compare [I-124]-CPD-1028 uptake in tumours to IGF-1R expression(Up to 18 days)
- Compare [I-124]-CPD-1028 PET/CT images to other imaging modalities(Up to 18 days)