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Imaging of Solid Tumors Using DLL3 SPECT

Megadott ok: Sponsor funding

Key facts

Phase
Korai 1. fázis

Trial details

Who runs it
Thomas Hope
Trial code
NCT07052760
Record updated
2026. április 29.
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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 20; 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.

Exclusion: 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; Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation; Known pregnancy.

ClinicalTrials.gov NCT07052760