Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

November 10, 2025 updated by: City of Hope Medical Center

Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)

This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the ability of 64Cu labeled M5A antibody (copper Cu 64 anti-CEA monoclonal antibody M5A) to localize CEA positive cancers (such as gastrointestinal, lung, medullary thyroid and breast cancers), as determined by PET imaging.

SECONDARY OBJECTIVES:

I. To characterize the frequency of titer of the human anti-human antibody (HAHA) response to 64Cu labeled M5A antibody.

II. To determine the safety of administration of 64Cu labeled M5A antibody.

OUTLINE:

Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A intravenously (IV) on day 0 and then undergo PET on day 1 and day 2.

After completion of study, patients are followed up at 1 and 3 months.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically confirmed primary or metastatic cancer; if biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope
  • Patients must have tumors that produce CEA as documented by a current or past history of an elevated serum CEA above the institutional limit of normal, or by immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from this requirement since > 95% are CEA positive
  • 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; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible
  • Although not mandated by the protocol, the results of the CT scan and labs (complete blood 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 should not have any uncontrolled illness including ongoing or active infection
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to copper Cu 64 anti-CEA monoclonal antibody M5A (64Cu-M5A)
  • Patients must not have received prior chemotherapy or radiation for >= 2 weeks before study enrollment
  • Pregnant women are excluded from this study; breastfeeding should be discontinued is the mother is treated with 54Cu-m5A
  • Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and has antibody to the M5A
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Procedure: radionuclide imaging
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
Other Names:
  • radionuclide scanning
Procedure: positron emission tomography
Undergo PET
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Drug: Cu 64 anti-CEA monoclonal antibody M5A IV
Cu 64 anti-CEA monoclonal antibody M5A IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1
Time Frame: At day 1
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day1 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
At day 1
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
Time Frame: At day 2
Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day 2 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
At day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody
Time Frame: At 1 and 3 months post study drug infusion
Approximately 5 ml (1 teaspoon) of blood in a red top tube will be drawn at 1 month post study drug infusion and 3 months post study drug infusion. Response at either 1 or 3 months post study drug infusion constitutes a positive response.
At 1 and 3 months post study drug infusion
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2
Time Frame: At day 1 and day 2
Scan results were compared to known sites of disease as defined by sites identified on CT scans, MRI scans, FDG PET scans, or sites identified at surgery that were histologically positive for cancer. The 64Cu SUVs on both day 1 and 2 scans were evaluated in tumors and selected nontumor organs and tissues (blood pool, liver, spleen, and kidney). Tumor uptake was measured in terms of SUVmax values, while organ uptake to assess biodistribution was measured in terms of SUVmean values. Ratios of tumor-to-blood activity concentration (T:B) were calculated as the ratio of tumor SUVmax to average SUV (SUVmean) measured in the blood pool.
At day 1 and day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jeffrey Wong, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2015

Primary Completion (Actual)

March 6, 2022

Study Completion (Estimated)

August 11, 2026

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimated)

November 19, 2014

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14238 (Other Identifier: City of Hope Medical Center)
  • NCI-2014-02079 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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