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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the diagnosis of certain cancers using a new imaging technique called PET scans with a special antibody. This antibody, Cu 64 anti-CEA monoclonal antibody M5A, targets a protein often found in tumors called CEA, helping to locate cancer that might be missed by usual methods. The study involves patients with confirmed CEA-producing cancers or colorectal cancer. Participants should have a known tumor site and must have completed any prior cancer treatments at least two weeks before joining. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research in cancer diagnosis.

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 prior data suggests that this diagnostic method is safe for patients?

Research has shown that the copper Cu 64 anti-CEA monoclonal antibody M5A treatment could help identify tumors in certain cancers, such as rectal and medullary thyroid cancer. This treatment aims to detect cancer cells that standard methods might miss.

Specific safety information is limited, as the trial is in a "Not Applicable" phase, indicating that safety is still under study and not fully confirmed. Treatments in early studies are generally monitored closely for side effects. So far, no major reports of serious side effects have emerged. However, patients should be aware of the possibility of allergic reactions, especially if they have experienced reactions to similar treatments before.

Overall, while the treatment shows promise in detecting cancer, participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET scan because it offers a new way to detect cancer using advanced imaging. Unlike traditional diagnostic methods, this approach uses a monoclonal antibody, M5A, that specifically targets CEA, a protein often found in higher amounts on cancer cells. By labeling M5A with the radioactive copper isotope Cu 64, the treatment provides clearer PET scan images, potentially leading to earlier and more accurate cancer detection. This innovative method could change how we identify and monitor cancer, making it easier to tailor treatments to individual patients.

What evidence suggests that this diagnostic method is effective for detecting CEA positive cancer?

Research has shown that a special type of scan, the copper Cu 64 anti-CEA monoclonal antibody M5A PET scan, may help detect certain cancers. In this trial, participants will receive the Cu 64 M5A injection and undergo PET scans to evaluate its effectiveness. Earlier studies demonstrated that this scan effectively finds tumors, especially in individuals with rectal and thyroid cancers. The images from this scan are highly detailed and can clearly distinguish between tumors and normal tissue just 24 hours after the injection. These early findings suggest that Cu 64 M5A could be a powerful tool for diagnosing cancers that regular scans might miss. ^{1 2 5 6 7}

Who Is on the Research Team?

Jeffrey Wong

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02293954

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36154291/

First-In-Human Pilot PET Immunoimaging Study of 64Cu ... 64 Cu-DOTA-hT84.66-M5A demonstrates promise in tumor detection, particularly in patients with locally advanced rectal cancer and medullary thyroid cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2553277/

PET IMAGING OF CEA-POSITIVE TUMORS WITH WHOLE ... ... imaging and 64Cu for PET imaging. The PET images obtained for 64Cu-labeled M5A show excellent tumor to normal tissue ratios as early as 24 h post injection ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02293954?term=AREA%5BConditionSearch%5D(%22Gallbladder%20Disease%22)%20AND%20AREA%5BInterventionSearch%5D(%22antibodies%22)&rank=2

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in ... This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing ...

5. liebertpub.com liebertpub.com/doi/10.1089/cbr.2022.0028

First-In-Human Pilot PET Immunoimaging Study of 64 Cu ... 64 Cu-DOTA-hT84.66-M5A demonstrates promise in tumor detection, particularly in patients with locally advanced rectal cancer and medullary thyroid cancer.

6. withpower.com withpower.com/trial/copper-cu-64-anti-cea-monoclonal-antibody-m5a-pet-scan-for-cancer-1ff58

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET ... 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 ...

7. ctv.veeva.com ctv.veeva.com/study/an-investigational-scan-64cu-labeled-m5a-antibody-in-combination-with-soc-chemotherapy-and-radioth

An Investigational Scan (64Cu-Labeled M5A Antibody) in ... This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients ...