This study is not yet accepting patients

Imaging of Solid Tumors Using DLL3 SPECT

a study on Solid Tumor Prostate Cancer Neuroendocrine (NE) Tumors Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Thomas A Hope, MD

Description

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.

Details

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.

Keywords

Solid Tumor Cancer, Castration Resistant Prostate Cancer, Castration Resistant Prostate Cancer (CRPC), Neuroendocrine (NE) Tumors, Imaging Agent Study, Neoplasms, Prostatic Neoplasms, Immunoconjugates, 111In-ABD147, Single-photon emission computed tomography (SPECT)/Computerized tomography (CT), High grade neuroendocrine tumor, Agnostic solid tumors

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT07052760
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 45 study participants
Last Updated