NCT04757090撤回2 期
A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT
研究概览
简要总结
This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111
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
- •Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111_001 (WU HRPO # 201907092).
- •Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111_
- •Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included.
- •Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes.
- •Able to undergo PET/CT imaging
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Hepatic only disease
- •Pregnant or breastfeeding.
研究组 & 干预措施
89Zr-trastuzumab PET/CT imaging
Experimental
- Enrolled subjects will be asked to undergo 18F-FDG PET/CT imaging (if not performed within the previous 90 days) and 89Zr-trastuzumab PET/CT imaging at baseline prior to the start of monotherapy MT-5111 treatment. Standard of care 18F-FDG PET/CT examinations performed within 90 days of 89Zr-trastuzumab administration can be used in place of a study specific 18F-FDG PET/CT scan. Baseline 89Zr-trastuzumab imaging should be completed no more than 30 days prior to initiating treatment with MT-5111.
- Cold trastuzumab and 89Zr-trastuzumab will be administered at Visit 1 and the 89Zr-trastuzumab PET/CT (Visit 2) will take place 4 days (+/-1 day) after administration of 89Zr-trastuzumab.
干预措施: 89Zr-trastuzumab (Drug)
结局指标
主要结局
Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT
时间窗: At baseline
-SUVmax is maximum standardized uptake value
次要结局
- Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT(At baseline)
- Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)(At baseline)
- Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT(At baseline)
研究者
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