NCT04692831进行中（未招募）1 期
Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Evaluate clinical safety of 89Zr-ss-pertuzumab
研究概览
简要总结
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease
- •Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH.
- •Biopsy proven primary malignancy or metastatic disease
- •At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- •Age 18 years or greater
- •ECOG performance of 0-2
排除标准
- •Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
- •AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
- •Life expectancy < 3 months
- •Pregnancy or lactation
- •Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
研究组 & 干预措施
HER2-positive malignancy
Experimental
Participants will have a diagnosis of HER2-positive malignancy
干预措施: 89Zr-ss-pertuzumab PET/CT (Combination Product)
HER2-low malignancy
Experimental
Participants will have a diagnosis of HER2-low malignancy
干预措施: 89Zr-ss-pertuzumab PET/CT (Combination Product)
结局指标
主要结局
Evaluate clinical safety of 89Zr-ss-pertuzumab
时间窗: Up to 20 months
CTCAE Version 5 will be utilized for toxicity evaluation
次要结局
未报告次要终点
研究者
研究点 (15)
Loading locations...
相似试验
招募中
早期 1 期
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy EffectivenessBreast CancerNCT03321045University of Alabama at Birmingham10
已完成
1 期
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer PatientsBreast NeoplasmsSecondaryHER2 Positive Carcinoma of BreastNCT01420146Jules Bordet Institute20
已完成
1 期
Imaging With a New Agent That Finds a Cancer Protein Called HER2HER2-positive CarcinomaHER2-positive Primary MalignancyNCT03109977Memorial Sloan Kettering Cancer Center6
招募中
1 期
HER2-PET Imaging in HER2-low Breast CancersBreast Cancer MetastaticNCT06732336Centre de recherche du Centre hospitalier universitaire de Sherbrooke40
终止
2 期
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast CancerHER2-positive Metastatic Breast CancerHER2-positive Advanced Breast CancerNCT06595563Jules Bordet Institute87