Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET Scan for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Uncontrolled illness, Active infection, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, any prior chemotherapy or radiation must be completed at least 2 weeks before the study.

What data supports the effectiveness of the treatment Cu 64 anti-CEA monoclonal antibody M5A for cancer?

The treatment, Cu 64 anti-CEA monoclonal antibody M5A, has shown promise in detecting tumors in patients with certain types of cancer, such as rectal and medullary thyroid cancer, by providing clear images that help identify the presence and extent of the disease. In a study, it successfully identified cancerous areas that were later confirmed by surgery or other imaging methods, suggesting it could be a useful tool in cancer detection and monitoring. ^{1 2 3 4 5}

Is the Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET Scan safe for humans?

In a pilot study with 20 patients, the Copper Cu 64 Anti-CEA Monoclonal Antibody M5A was used for PET scans and showed promise in detecting tumors, with no specific safety concerns reported in the study. ^{1 2 6 7 8}

How is the Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET Scan treatment different from other cancer treatments?

This treatment is unique because it uses a radiolabeled antibody specifically targeting carcinoembryonic antigen (CEA) for PET imaging, allowing for precise detection of CEA-expressing tumors. It combines the targeting ability of antibodies with the imaging capabilities of copper-64, providing detailed images of tumor presence and response to therapy, which is not typically available with standard imaging techniques. ^{1 2 4 6 9}

Research Team

Jeffrey Wong

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with certain types of cancer that produce a marker called CEA. They must have completed any previous treatments at least 2 weeks before, agree to use contraception, and not be pregnant or breastfeeding. People with uncontrolled illnesses or allergies to similar drugs are excluded.

Inclusion Criteria

I have recent (within 2 months) CT scans and blood tests.

I can understand and am willing to sign the consent form.

I finished any cancer treatments like chemotherapy or radiotherapy at least 2 weeks ago.

Exclusion Criteria

I have had allergic reactions to similar drugs or substances as 64Cu-M5A.

I am not pregnant and will stop breastfeeding if treated with 54Cu-m5A.

I do not have any uncontrolled illnesses or active infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person) at 1 and 3 months

Treatment Details

Interventions

• Cu 64 anti-CEA monoclonal antibody M5A

Trial Overview The study tests a diagnostic procedure using Copper Cu 64 anti-CEA monoclonal antibody M5A PET scans to detect cancers expressing the CEA marker more effectively than standard methods.

Participant Groups

Group I: Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET) Experimental Treatment 5 Interventions

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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a pilot study involving 20 patients with CEA-expressing cancers, the radiolabeled antibody 64Cu-DOTA-hT84.66-M5A showed promising results in detecting tumors, particularly in patients with locally advanced rectal cancer and medullary thyroid cancer, with a high concordance between PET scan results and biopsy findings.

The study indicated that 64Cu-DOTA-hT84.66-M5A could identify tumors not visible on standard imaging methods, suggesting its potential as a valuable tool for assessing tumor response to therapies and guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-In-Human Pilot PET Immunoimaging Study of 64Cu-Anti-Carcinoembryonic Antigen Monoclonal Antibody (hT84.66-M5A) in Patients with Carcinoembryonic Antigen-Producing Cancers. Wong, JYC., Yamauchi, DM., Adhikarla, V., et al.[2023]

The (64)Cu-DOTA-labeled M5A antibody effectively targets and images CEA-positive liver metastases in mice, showing significantly higher uptake in tumors compared to healthy liver tissue and CEA-negative metastases, indicating its potential for accurate cancer detection.

This study suggests that the M5A antibody could be a valuable tool for staging colorectal cancer and guiding treatment decisions, including radioimmunotherapy, based on its ability to differentiate between cancerous and non-cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioimmunoimaging of liver metastases with PET using a 64Cu-labeled CEA antibody in transgenic mice. Nittka, S., Krueger, MA., Shively, JE., et al.[2021]

Four monoclonal antibodies (MAbs) against human carcinoembryonic antigen (CEA) were developed, with MAb C27 showing the highest affinity for CEA and no cross-reactivity with normal human colon tissues, indicating its specificity for cancer detection.

MAb C27 demonstrated strong immunofluorescence staining in colorectal cancer cells, correlating well with CEA content, and showed 100% positivity in colorectal carcinoma tissues, suggesting its potential use in immunodetection and radiolocalization of colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunological characteristics of monoclonal antibodies against human carcinoembryonic antigen (CEA). Tsai, LC., Wang, FM., Pan, LC., et al.[2015]

Copper-64 can effectively target tumor cell nuclei, with significantly higher nuclear uptake observed in p53-positive colorectal cancer cells compared to p53-negative cells, suggesting that the presence of the p53 protein enhances the delivery of this radiopharmaceutical.

Both non-specific and receptor-mediated mechanisms contribute to the nuclear localization of Copper-64, indicating its potential for effective targeted radiotherapy in cancers expressing the p53 tumor suppressor protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of p53 in the trafficking of copper-64 to tumor cell nuclei. Eiblmaier, M., Meyer, LA., Anderson, CJ.[2020]

The study demonstrated that Copper-64 labeled monoclonal antibodies (1A3 and its fragments) provide superior tumor imaging capabilities compared to traditional 111In and 125I labeled antibodies in a hamster model, indicating enhanced sensitivity for PET imaging of colorectal cancer.

While 64Cu-benzyl-TETA-1A3 shows promise for clinical use in PET imaging, the high kidney uptake of its fragment 64Cu-benzyl-TETA-1A3-F(ab')2 currently limits its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copper-64-labeled antibodies for PET imaging. Anderson, CJ., Connett, JM., Schwarz, SW., et al.[2016]

A genetically engineered minibody derived from the anti-CEA antibody showed high uptake in CEA-positive tumors during PET imaging, indicating its potential for effective tumor targeting with a significant target/background ratio of 3-4:1.

The use of copper-64 as a short-lived radionuclide for labeling these engineered antibody fragments allows for rapid imaging, making it a promising approach for enhancing the detection of tumors compared to traditional whole antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution microPET imaging of carcinoembryonic antigen-positive xenografts by using a copper-64-labeled engineered antibody fragment. Wu, AM., Yazaki, PJ., Tsai, Sw., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

First-In-Human Pilot PET Immunoimaging Study of 64Cu-Anti-Carcinoembryonic Antigen Monoclonal Antibody (hT84.66-M5A) in Patients with Carcinoembryonic Antigen-Producing Cancers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Radioimmunoimaging of liver metastases with PET using a 64Cu-labeled CEA antibody in transgenic mice. [2021]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Immunological characteristics of monoclonal antibodies against human carcinoembryonic antigen (CEA). [2015]

4. United States pubmed.ncbi.nlm.nih.gov

A versatile bifunctional chelate for radiolabeling humanized anti-CEA antibody with In-111 and Cu-64 at either thiol or amino groups: PET imaging of CEA-positive tumors with whole antibodies. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Somatic-cell hybrids producing antibodies against CEA. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Antibody labeling with copper-67 using the bifunctional macrocycle 4-[(1,4,8,11-tetraazacyclotetradec-1-yl)methyl]benzoic acid. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The role of p53 in the trafficking of copper-64 to tumor cell nuclei. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Copper-64-labeled antibodies for PET imaging. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

High-resolution microPET imaging of carcinoembryonic antigen-positive xenografts by using a copper-64-labeled engineered antibody fragment. [2018]