NCT02293954

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
3mo left

Started Nov 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Nov 2015Aug 2026

First Submitted

Initial submission to the registry

October 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

November 11, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2023

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2026

Expected
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

6.3 years

First QC Date

October 9, 2014

Results QC Date

February 28, 2023

Last Update Submit

November 10, 2025

Conditions

Breast CancerColon CancerExtrahepatic Bile Duct CancerGallbladder CancerGastrointestinal CancerLiver and Intrahepatic Biliary Tract CancerLung CancerMetastatic CancerPancreatic CancerRectal CancerThyroid Gland Medullary CarcinomaUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Tumor Uptake of 64Cu-DOTA-hT4.66-M5A 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

    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 Outcomes (2)

  • Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody

    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

    At day 1 and day 2

Study Arms (1)

Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)

EXPERIMENTAL

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

Procedure: radionuclide imagingProcedure: positron emission tomographyOther: laboratory biomarker analysisOther: pharmacological studyDrug: Cu 64 anti-CEA monoclonal antibody M5A IV

Interventions

radionuclide imagingPROCEDURE

Given copper Cu 64 anti-CEA monoclonal antibody M5A IV

Also known as: radionuclide scanning
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
positron emission tomographyPROCEDURE

Undergo PET

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
Cu 64 anti-CEA monoclonal antibody M5A IVDRUG

Cu 64 anti-CEA monoclonal antibody M5A IV

Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

  • Wong JYC, Yamauchi DM, Adhikarla V, Simpson J, Frankel PH, Fong Y, Melstrom KA, Chen YJ, Salehian BD, Woo Y, Dandapani SV, Colcher DM, Poku EK, Yazaki PJ, Wu AM, Shively JE. First-In-Human Pilot PET Immunoimaging Study of 64Cu-Anti-Carcinoembryonic Antigen Monoclonal Antibody (hT84.66-M5A) in Patients with Carcinoembryonic Antigen-Producing Cancers. Cancer Biother Radiopharm. 2023 Feb;38(1):26-37. doi: 10.1089/cbr.2022.0028. Epub 2022 Sep 26.

    PMID: 36154291DERIVED

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsGastrointestinal NeoplasmsCarcinoma, HepatocellularLung NeoplasmsNeoplasm MetastasisPancreatic NeoplasmsRectal NeoplasmsCarcinoma, Medullary

Interventions

Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Paul Frankel, Ph.D.
Organization
City of Hope
pfrankel@coh.org
626-218-5265

Study Officials

  • Jeffrey Wong

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

November 19, 2014

Study Start

November 11, 2015

Primary Completion

March 6, 2022

Study Completion (Estimated)

August 11, 2026

Last Updated

November 14, 2025

Results First Posted

April 21, 2023

Record last verified: 2025-11

Locations

US(1)