Imaging of Solid Tumors Using DLL3 SPECT
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Thomas Hope
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Standardized Uptake Values (SUVs)
研究概览
简要总结
This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants with solid tumors. 111In-ABD147 is a high affinity Delta-like ligand 3 (DLL3) antigen binding domain fused to an engineered humanized Fc to create an antibody (VHH-Fc) that is bio-conjugated with a DOTA linker-chelator to a 111In radiometal. DLL3 is expressed on a variety of tumors, particularly those with neuroendocrine features.
详细描述
PRIMARY OBJECTIVE:
1) Determine the feasibility of detecting tumor uptake using 111In-ABD147.
SECONDARY OBJECTIVE:
1) Safety of 111In-ABD147.
EXPLORATORY OBJECTIVES:
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
- •Age ≥ 18 years
- •Histopathologically confirmed solid tumors in one of the following cohorts:
- •Cohort 1 (n=15): Histologically confirmed prostate cancer, with castration resistant disease per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
- •Cohort 2 (n=15): Histologically confirmed high grade neuroendocrine tumor, with a Ki-67 over
- •Cohort 3 (n=15): Agnostic to tumor type.
- •Metastatic disease present on conventional imaging defined as having Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or multiple bone metastases.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- •Has known hypersensitivity to Chinese hamster ovary cell products.
- •Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- •Known pregnancy.
研究组 & 干预措施
Cohort 1: Castration resistant prostate cancer
Participants will receive a single administration of 185 megabecquerels (MBq) (5 millicurie (mCi)) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: 111In-ABD147 (Drug)
Cohort 1: Castration resistant prostate cancer
Participants will receive a single administration of 185 megabecquerels (MBq) (5 millicurie (mCi)) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) (Procedure)
Cohort 2: High grade neuroendocrine tumor
Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: 111In-ABD147 (Drug)
Cohort 2: High grade neuroendocrine tumor
Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) (Procedure)
Cohort 3: Agnostic solid tumors
Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: 111In-ABD147 (Drug)
Cohort 3: Agnostic solid tumors
Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
干预措施: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) (Procedure)
结局指标
主要结局
Standardized Uptake Values (SUVs)
时间窗: 2 days
Standardized Uptake Values (SUVs) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range will be reported across all Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesions broken down by location (organ metastases, nodal metastases and bone metastases).
Tumor-to-background ratio (TBR)
时间窗: 2 days
Tumor-to-background ratios (TBR) ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions broken down by location (organ metastases, nodal metastases and bone metastases).
次要结局
- Percentage of participants with treatment-emergent adverse events(Up to 7 days)
研究者
Thomas Hope
Professor In Residence
University of California, San Francisco