Imaging of Solid Tumors Using DLL3 SPECT
brief summary
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.
detailed description
PRIMARY OBJECTIVE:
1\) Determine the feasibility of detecting tumor uptake using 111In-ABD147.
SECONDARY OBJECTIVE:
1\) Safety of 111In-ABD147.
EXPLORATORY OBJECTIVES:
1. Correlation of 111In-ABD147 uptake with DLL3 expression determined by immunohistochemistry. 2. Compare 111In-ABD147 scan results to archival Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) images when available.
OUTLINE:
Participants will be assigned to cohorts based on solid tumor diagnosis. All participants will receive 1 dose of study drug followed by single-photon emission computed tomography (SPECT)/Computerized tomography (CT) imaging. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after last dose for safety.