ImmunoPET Imaging With ZED88082A in Patients Before and During Treatment With 1) MPDL3280A or 2) PD-1 Antibody Plus or Minus Ipilimumab
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Appropriate dosing of anti-CD8 imaging agent and PET imaging time points
研究概览
简要总结
This is a single-center, single-arm, investigator sponsored trial designed to evaluate the PK of the anti-CD8 imaging agent in patients prior to and during treatment with checkpoint inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects with histologically confirmed locally advanced or metastatic cancer for the following tumor types
- •Cancer types other than melanoma; subjects meeting the eligibility criteria as formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B
- •Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus or minus ipilimumab, are eligible for part B
- •Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- •Measurable disease, as defined by standard RECIST v1.
- •Previously irradiated lesions should not be counted as target lesions.
- •Signed informed consent.
- •Age ≥18 at the time of signing informed consent.
- •Life expectancy ≥12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Ability to comply with the protocol.
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).
排除标准
- •Potential subjects with cancer other than melanoma will be excluded from participation in this study if they meet exclusion criteria formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
- •Signs or symptoms of infection within 2 weeks prior to anti-CD8 imaging agent injection.
- •Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies.
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the anti-CD8 imaging agent, or that may affect the interpretation of the results or render the patient at high risk from complications.
- •Pregnant or lactating women.
结局指标
主要结局
Appropriate dosing of anti-CD8 imaging agent and PET imaging time points
时间窗: 2 years
Appropriate dosing and imaging time points of the anti-CD8 imaging agent will be determined based on measurements of standardized uptake value (SUV) of defined volumes of interest (VOIs) on the immunoPET scan images
Pharmacokinetics (PK) of anti-CD8 imaging agent
时间窗: 2 years
Description of PK of the anti-CD8 imaging agent by measuring standardized uptake value (SUV) on PET scans performed 0, 2, 4 and/or 7 days after tracer injection before and during MPDL3280A or PD-1 antibody immune checkpoint inhibitor plus or minus ipilimumab treatment.
Incidence of adverse events related to tracer administration as assessed by CTCAE v4.0
时间窗: 2 years
Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to ZED88082A/CED88004S. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
Immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies
时间窗: 2 years
Assessment of the immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies during the study relative to the prevalence of ADAs at baseline and assessing their relationship to other outcomes measured.
次要结局
- Heterogeneity of tumor uptake of the anti-CD8 imaging agent(2 years)
- Correlation of anti-CD8 imaging agent normal tissue kinetics with blood kinetics(2 years)
- Dosimetry(2 years)
- Correlation of normal organ uptake of the anti-CD8 imaging agent to (serious) adverse events (possibly) related to immune checkpoint inhibitor treatment(2 years)
- Correlation of tumor uptake of the anti-CD8 imaging agent and immune cell CD8 expression(2 years)