Study Stopped
Sponsor funding
Imaging of Solid Tumors Using DLL3 SPECT
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Apr 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2025
CompletedFirst Posted
Study publicly available on registry
July 7, 2025
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
April 29, 2026
April 1, 2026
2.1 years
June 28, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Standardized Uptake Values (SUVs)
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).
2 days
Tumor-to-background ratio (TBR)
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).
2 days
Secondary Outcomes (1)
Percentage of participants with treatment-emergent adverse events
Up to 7 days
Study Arms (3)
Cohort 1: Castration resistant prostate cancer
EXPERIMENTALParticipants 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.
Cohort 2: High grade neuroendocrine tumor
EXPERIMENTALParticipants 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.
Cohort 3: Agnostic solid tumors
EXPERIMENTALParticipants 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.
Interventions
Given intravenously (IV) prior to imaging
Undergo imaging
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Hopelead
- Abdera Therapeutics Inc.collaborator
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A Hope, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor In Residence
Study Record Dates
First Submitted
June 28, 2025
First Posted
July 7, 2025
Study Start
April 30, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
De-identified data may be shared with collaborating sponsors during the course of the study