An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
NCT ID: NCT05245786
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
15 participants
INTERVENTIONAL
2022-08-31
2026-11-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (64Cu labeled M5A antibody and imaging)
Patients receive 64Cu labeled M5A antibody 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.
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
Given IV
Imaging Technique
Undergo imaging
Interventions
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Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
Given IV
Imaging Technique
Undergo imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be 18 years of age or older
* The effects of 64Cu-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence} prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* Patients must have a known site of disease. Patients must be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery
* Patients who are planned for total neoadjuvant therapy where additional chemotherapy is planned before neoadjuvant chemoradiotherapy (CRT) are also eligible
* Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell count \[CBC\], comprehensive metabolic panel \[CMP\]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody
Exclusion Criteria
* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-M5A
* Pregnant women are excluded from this study because 64Cu-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with \^64Cu-M5A, breastfeeding should be discontinued if the mother is treated with 64Cu-M5A
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jeffrey Y Wong
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Jeffrey Y. Wong
Role: primary
Other Identifiers
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NCI-2021-14005
Identifier Type: REGISTRY
Identifier Source: secondary_id
20439
Identifier Type: OTHER
Identifier Source: secondary_id
20439
Identifier Type: -
Identifier Source: org_study_id