Solid Tumor CancerEarly Phase 1NCT07052760
Imaging of Solid Tumors Using DLL3 SPECT
A Early Phase 1 study testing 111In-ABD147 and Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) in people with Solid Tumor Cancer and Castration Resistant Prostate Cancer, run by Thomas Hope.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Castration Resistant Prostate Cancer, Castration Resistant Prostate Cancer (CRPC)
- What is being tested?
- 111In-ABD147 and Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 May 2028
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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 the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of detecting tumor uptake using 111In-ABD147.
SECONDARY OBJECTIVE:
- Safety of 111In-ABD147.
EXPLORATORY OBJECTIVES:
- Correlation of 111In-ABD147 uptake with DLL3 expression determined by immunohistochemistry.
- 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.
- Conditions
- Solid Tumor Cancer, Castration Resistant Prostate Cancer, Castration Resistant Prostate Cancer (CRPC), Neuroendocrine (NE) Tumors
- Being tested
- 111In-ABD147, Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
- Keywords
- Imaging Agent Study
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
111In-ABD147Drug
Also called Radioimmunoconjugate
Given intravenously (IV) prior to imaging
Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)Procedure or surgery
Also called SPECT/CT
Undergo imaging
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Castration resistant prostate cancer | Experimental | 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. Receives: Drug: 111In-ABD147; Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) |
| Cohort 2: High grade neuroendocrine tumor | Experimental | 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. Receives: Drug: 111In-ABD147; Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) |
| Cohort 3: Agnostic solid tumors | Experimental | 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. Receives: Drug: 111In-ABD147; Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 days
Secondary outcomes (1)
Percentage of participants with treatment-emergent adverse events
The percentage of participants with reported treatment-emergent adverse events and the 95% confidence interval following 111In-ABD147 injection will be descriptively reported, using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study start30 Apr 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Why it stopped: Sponsor funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Collaborators
- Abdera Therapeutics Inc.
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas A Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052760
- Sponsor's protocol ID
- 25926
- Other IDs
- NCI-2025-04590
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with collaborating sponsors during the course of the study
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Solid Tumors Using DLL3 SPECT
- ClinicalTrials.gov ID
- NCT07052760
- Acronym / sponsor ID
- 25926
- Conditions
- Solid Tumor Cancer, Castration Resistant Prostate Cancer, Castration Resistant Prostate Cancer (CRPC), Neuroendocrine (NE) Tumors
- Keywords
- Imaging Agent Study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Collaborators
- Abdera Therapeutics Inc.
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 7 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the feasibility of detecting tumor uptake using 111In-ABD147.
SECONDARY OBJECTIVE:
- Safety of 111In-ABD147.
EXPLORATORY OBJECTIVES:
- Correlation of 111In-ABD147 uptake with DLL3 expression determined by immunohistochemistry.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Castration resistant prostate cancer | Experimental | Drug: 111In-ABD147, Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)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. |
| Cohort 2: High grade neuroendocrine tumor | Experimental | Drug: 111In-ABD147, Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)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. |
| Cohort 3: Agnostic solid tumors | Experimental | Drug: 111In-ABD147, Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Histopathologically confirmed solid tumors in one of the following cohorts:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 111In-ABD147Also: RadioimmunoconjugateGiven intravenously (IV) prior to imaging | Drug | Cohort 1: Castration resistant prostate cancer, Cohort 2: High grade neuroendocrine tumor, Cohort 3: Agnostic solid tumors |
| Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)Also: SPECT/CTUndergo imaging | Procedure or surgery | Cohort 1: Castration resistant prostate cancer, Cohort 2: High grade neuroendocrine tumor, Cohort 3: Agnostic solid tumors |
Primary outcome
Standardized Uptake Values (SUVs)
Time frame: 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)
Time frame: 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).
1 secondary outcome
Percentage of participants with treatment-emergent adverse events
Time frame: Up to 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with collaborating sponsors during the course of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Hope, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 111In-ABD147 and Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) in people with Solid Tumor Cancer and Castration Resistant Prostate Cancer, run by Thomas Hope.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Values (SUVs) (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.