Castration Resistant Prostate Cancer, Castration Resistant Prostate Cancer (CRPC), Neuroendocrine (NE) Tumors, Solid Tumor Cancer
Conditions
Keywords
Imaging Agent Study
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.
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.
Interventions
DRUG111In-ABD147
Given intravenously (IV) prior to imaging
Undergo imaging
Sponsors
Thomas Hope
Abdera Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Values (SUVs) | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events | Up to 7 days | 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. |
Contacts
PRINCIPAL_INVESTIGATORThomas A Hope, MD
University of California, San Francisco
Outcome results
None listed