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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04590 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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Sponsor funding
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| Name | Class |
|---|---|
| Abdera Therapeutics Inc. | INDUSTRY |
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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.
PRIMARY OBJECTIVE:
1) Determine the feasibility of detecting tumor uptake using 111In-ABD147.
SECONDARY OBJECTIVE:
1) Safety of 111In-ABD147.
EXPLORATORY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 111In-ABD147 | Drug | Given intravenously (IV) prior to imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Hope, MD | University of California, San Francisco | Principal Investigator |
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De-identified data may be shared with collaborating sponsors during the course of the study
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
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| Single-photon emission computed tomography (SPECT)/Computerized tomography (CT) | Procedure | Undergo imaging |
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| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |