Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.
研究概览
简要总结
The purpose of this study is to determine if the radiotracer, [68Ga]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
详细描述
This study will assess a dose of ABY-025 followed by a tracer dose of [68Ga]Ga-ABY-025 in subjects with HER2+ solid cancers, or HER2+ or low breast cancer undergoing or planning to undergo treatment with standard-of-care HER2-targeted therapy for an FDA-approved indication. The study drug will be administered and [68Ga]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug. Patients will have a follow visit 2-7 days post injection of the study drug. Additionally, subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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.
- •Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.
- •Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.
- •Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
- •Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
排除标准
- •Measurable sites of disease only in the liver.
- •Inability to comply with study procedures.
- •Hypersensitivity or allergy to any component of [68Ga]Ga-ABY-
- •Pregnant or breastfeeding.
- •HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
- •Inability to lie flat for 30 minutes during an imaging session.
- •Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
研究组 & 干预措施
Study Arm (ABY-025)
This is a pilot study of [68Ga]Ga-ABY-025, a radiolabeled affibody, imaging in patients undergoing treatment with HER2-targeted therapy. The PET/CT imaging ("HER2 PET" imaging) will be performed at, prior to, or during the time a patient is receiving treatment with HER2-targeted therapy. A second HER2 PET will be collected at time of therapy treatment discontinuation or 12 months from study consent. Patients will be infused with the study drug, [68Ga]Ga-ABY-025, followed by PET/CT imaging post infusion. Participants will undergo follow-up visits to assess for adverse reactions 2-7 days post infusion and again at the patient's standard of care visit. Participants will undergo standard of care work-up for their malignancy as determined by their treatment team (e.g. biopsy, additional imaging, observation, treatment for metastatic disease). Either at 12 months after enrollment in the study or at the time of treatment discontinuation (whichever comes first), repeat HER2 PET imaging will
干预措施: [68Ga]Ga-ABY-025 (Drug)
Study Arm (ABY-025)
This is a pilot study of [68Ga]Ga-ABY-025, a radiolabeled affibody, imaging in patients undergoing treatment with HER2-targeted therapy. The PET/CT imaging ("HER2 PET" imaging) will be performed at, prior to, or during the time a patient is receiving treatment with HER2-targeted therapy. A second HER2 PET will be collected at time of therapy treatment discontinuation or 12 months from study consent. Patients will be infused with the study drug, [68Ga]Ga-ABY-025, followed by PET/CT imaging post infusion. Participants will undergo follow-up visits to assess for adverse reactions 2-7 days post infusion and again at the patient's standard of care visit. Participants will undergo standard of care work-up for their malignancy as determined by their treatment team (e.g. biopsy, additional imaging, observation, treatment for metastatic disease). Either at 12 months after enrollment in the study or at the time of treatment discontinuation (whichever comes first), repeat HER2 PET imaging will
干预措施: ABY-025 Loading Dose (Drug)
结局指标
主要结局
Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.
时间窗: up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.
Outcome Measure: After study enrollment, subjects will receive \[68Ga\]Ga-ABY-025 infusion and undergo PET/CT scan. Patients will be immediately assessed for adverse events within the first 30 minutes of infusion and 2-7 days post-infusion from the study coordinator. Adverse events will be monitored up to 21±14 days following the infusion of study drug. Repeat infusion and imaging will be obtained either at the time of treatment discontinuation or at 12 months from study consent and will have the same safety monitoring parameters. While there are expected adverse events related to anti-cancer therapy, we will specifically be reporting adverse events that are "definitely related" or "probably related" to the study agent.
次要结局
未报告次要终点
研究者
Eben Rosenthal
Barry and Amy Baker Professor and Chair
Vanderbilt-Ingram Cancer Center