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Investigating 64Cu-Labeled M5A Antibody Scan for Locally Advanced Rectal Cancer

This study is looking at how well a special scan, using Copper Cu 64 Anti-CEA Monoclonal Antibody M5A, works for people with locally advanced rectal cancer (cancer that has spread to nearby tissues or lymph nodes). The scan is given before and after standard chemotherapy and radiation. Researchers want to see if this scan helps doctors make better decisions about your treatment, either before starting therapy or before surgery. The study will also check the safety of the Copper Cu 64 Anti-CEA Monoclonal Antibody M5A. You may be able to join if you are 18 or older and have this type of rectal cancer where the tumor produces a protein called CEA. The study aims to see if the scan provides useful information for patient care, with results being tracked for up to 3 years. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 14 participants. It is an early phase trial, but the specific phase is not stated.
What's involved
You would receive Copper Cu 64 Anti-CEA Monoclonal Antibody M5A intravenously twice, once before and once after standard chemotherapy/radiotherapy. You would also undergo two PET scans, one after each antibody administration.
Compensation
Not stated in the trial record.
Follow-up
After the study treatment, your medical records will be reviewed for up to 2-3 months. The primary endpoint is measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05245786

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

Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~14 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Copper Cu 64 Anti-CEA Monoclonal Antibody M5AImaging Technique

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with impactful finding using 64Cu-M5A positron emission tomography (PET) imaging.
Measured over Up to 3 years

Conditions

Locally Advanced Rectal Carcinoma
Stage III Rectal Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8

Explore related trials

Rectal CarcinomaCarcinoembryonic Antigen

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeffrey Y Wong · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus \[+\])
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

Patients should not have any uncontrolled illness including ongoing or active infection
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

What this trial measures

  • Number of patients with impactful finding using 64Cu-M5A positron emission tomography (PET) imaging.Up to 3 years

    We seek to evaluate the potential for 64Cu-M5A PET imaging in locally advanced rectal cancer before and after neoadjuvant radio-chemotherapy yet prior to planned surgery. Scan findings will be compared to standard of care imaging studies (eg. CT, MRI and FDG PET scans) and biopsy and findings from endoscopy and surgery performed post neoadjuvant CRT therapy. Each of the 15 cases will be reviewed in a protocol team meeting consisting of a radiologist, radiation oncologist, surgeon and pathologist. Cases will be determined by consensus. Examples of "potentially impactful" would be 1) any new lesion not seen on other imaging modalities and confirmed by pathology, 2) a negative 64CuM5A PET on a suspicious lesion by standard of care (SOC) determined to be negative on pathology, or 3) other important differences as judged by the evaluation team including if findings from initial 64CuDOTA-M5A immunoPET imaging could result in modification and adaption of the radiotherapy plan.