Trials / Not Yet Recruiting
Not Yet RecruitingNCT07052760
Imaging of Solid Tumors Using DLL3 SPECT
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Thomas Hope · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumor Cancer
- Castration Resistant Prostate Cancer
- Castration Resistant Prostate Cancer (CRPC)
- Neuroendocrine (NE) Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 111In-ABD147 | Given intravenously (IV) prior to imaging |
| PROCEDURE | Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) | Undergo imaging |
Timeline
- Start date
- 2025-11-30
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2025-07-07
- Last updated
- 2025-10-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07052760. Inclusion in this directory is not an endorsement.