Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- ratio of tumor SUVs to reference tissue SUVs
研究概览
简要总结
Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.
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
- •Aged 18 years and above
- •Patients with at least one imageable primary or metastatic lesion > 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months
- •Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy.
- •Cohort 2: Patients with untreated renal cell carcinoma on active surveillance
- •Women of child bearing potential must not be pregnant on study entry
- •Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation.
排除标准
- •Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator
- •Patients with urinary catheters or stoma bags
- •Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine
- •Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded
- •Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors
- •Participant enrolled into another therapeutic intervention study
- •Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
- •Women who are pregnant or breast feeding
- •Unable to provide informed consent
研究组 & 干预措施
Single Arm
Eligible subjects will receive up to two zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 2.0 mCi ± 20% and 3.0 mg API) as an IV infusion or slow bolus injection.
PET/CT imaging is performed 24hrs ± 3hrs post administration. The two scans are performed a minimum 2 weeks apart.
干预措施: Zirconium 89Zr crefmirlimab berdoxam (Biological)
结局指标
主要结局
ratio of tumor SUVs to reference tissue SUVs
时间窗: 2-4 weeks
Absolute and relative difference in SUV ratios
SUVs in tumor
时间窗: 2-4 weeks
Absolute and relative difference in tumor SUVs
SUVs in reference tissues
时间窗: 2-4 weeks
Absolute and relative difference in reference tissue SUVs
次要结局
- Safety of repeat doses of Zr-89 crefmirlimab berdoxam(Through study completion, an average of 8 weeks)