An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

Description

PRIMARY OBJECTIVE:

I. To determine if the Copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A (64Cu labeled M5A antibody) demonstrates a potentially impactful finding for patient management either in the pre-treatment scan (potentially impacting choice of therapy or impacting the radiotherapy [RT] plan) or the scan immediately prior to planned surgery (after standard care [SOC] chemoradiation) in patients with locally advanced rectal cancer.

SECONDARY OBJECTIVES:

I. To determine the safety of administration of 64Cu labeled M5A antibody. II. To describe/summarize each of the 15 patients’ 64Cu-M5A positron emission tomography (PET) imaging findings and corresponding SOC scans and pathology.

OUTLINE:

Patients receive 64Cu labeled M5A antibody intravenously (IV) over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy.

After completion of the study treatment, patients medical records are reviewed up to 2-3 months.