An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer

NCT03993327 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 18386NCI-2019-01923
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. M5A binds to CEA-positive cancer cells and may, through imaging scans, be able to detect liver metastases by picking up signals from I-124.

Conditions

Colorectal Carcinoma Metastatic in the Liver; Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A

  Will be observed using standard imaging scans obtained pre-operatively and to assess if the antibody detects new liver metastases. Serum concentration data will be tabulated and descriptive statistics computed.

  Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion

• Percent of known liver lesions per standard staging scans identified on iodine I-124 (I-124) M5A imaging

  Up to 1 year

Secondary Outcomes (5)

• Surgical results (when available per standard of care surgery/pathology) on lesions negative on I-124 M5A but positive on standard scans

  Up to 1 year

• Percent of patients with suspicious liver lesions identified on I-124 M5A but were not identified on standard imaging

  Up to 1 year

• Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging

  Up to 1 year

• I-124 identification of extra-hepatic lesions (both previously noted or new)

  Up to 1 year

• Incidence of adverse events

  Up to 14 days post infusion

Study Arms (1)

Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)

EXPERIMENTAL

Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.

Biological: Iodine I 124 Monoclonal Antibody M5A; Procedure: Positron Emission Tomography

Interventions

Iodine I 124 Monoclonal Antibody M5A BIOLOGICAL

Given IV

Also known as: 124I-M5A, Iodine I 124 Anti-CEA Monoclonal Antibody M5A

Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed metastatic colorectal cancer with liver metastases. NOTE: We are not requiring proof of CEA positive disease because \> 95% of colorectal cancers are CEA positive
• The effects of 124I-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 at least 2 known sites of metastatic liver disease. Patients should have at least one resectable liver metastasis as assessed by hepatobiliary surgical oncology
• The results of the imaging scans 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
• Patients who have allergy to iodine or iodine contrast agents are not eligible for this protocol
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 124I-M5A
• Patients must not have received prior chemotherapy or radiation for \>= 2 weeks before study enrollment
• Pregnant women are excluded from this study because 124I-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 124I-M5A, breastfeeding should be discontinued if the mother is treated with 124I-M5A
• Patients with single (= 1) liver metastasis are not eligible for this protocol
• Any patient who has had exposure to mouse, chimeric (human/mouse) or humanized 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Savita V Dandapani

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 20, 2019
• Study Start: July 15, 2020
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

US (1)