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Imaging of Solid Tumors Using DLL3 SPECT | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

Imaging of Solid Tumors Using DLL3 SPECT

NCT07052760•Thomas Hope

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Histopathologically confirmed solid tumors in one of the following cohorts:
•1. Cohort 1 (n=15): Histologically confirmed prostate cancer, with castration resistant disease per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
•2. Cohort 2 (n=15): Histologically confirmed high grade neuroendocrine tumor, with a Ki-67 over 20.
•3. Cohort 3 (n=15): Agnostic to tumor type.
•3. Metastatic disease present on conventional imaging defined as having Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or multiple bone metastases.
•4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

•1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
•2. Has known hypersensitivity to Chinese hamster ovary cell products.
•3. Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
•4. Known pregnancy.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

November 30, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

October 10, 2025

Enrollment

ESTIMATED participants

Conditions

Solid Tumor CancerCastration Resistant Prostate CancerCastration Resistant Prostate Cancer (CRPC)Neuroendocrine (NE) Tumors

Interventions

111In-ABD147

DRUG

Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)

PROCEDURE

Contacts

Maya Aslam

CONTACT

(415) 514-8987 Maya.Aslam@ucsf.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Imaging of Solid Tumors Using DLL3 SPECT

Inclusion Criteria

Exclusion Criteria

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