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An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

Primary Purpose

Locally Advanced Rectal Carcinoma, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
Imaging Technique
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus [+])
  • Patients must be 18 years of age or older
  • The effects of 64Cu-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 a known site of disease. Patients must be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery
  • Patients who are planned for total neoadjuvant therapy where additional chemotherapy is planned before neoadjuvant chemoradiotherapy (CRT) are also eligible
  • Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell 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
  • Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-M5A
  • Pregnant women are excluded from this study because 64Cu-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 ^64Cu-M5A, breastfeeding should be discontinued if the mother is treated with 64Cu-M5A
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (64Cu labeled M5A antibody and imaging)

Arm Description

Patients receive 64Cu labeled M5A antibody IV over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy.

Outcomes

Primary Outcome Measures

Number of patients with impactful finding using 64Cu-M5A positron emission tomography (PET) imaging.
We seek to evaluate the potential for 64Cu-M5A PET imaging in locally advanced rectal cancer before and after neoadjuvant radio-chemotherapy yet prior to planned surgery. Scan findings will be compared to standard of care imaging studies (eg. CT, MRI and FDG PET scans) and biopsy and findings from endoscopy and surgery performed post neoadjuvant CRT therapy. Each of the 15 cases will be reviewed in a protocol team meeting consisting of a radiologist, radiation oncologist, surgeon and pathologist. Cases will be determined by consensus. Examples of "potentially impactful" would be 1) any new lesion not seen on other imaging modalities and confirmed by pathology, 2) a negative 64CuM5A PET on a suspicious lesion by standard of care (SOC) determined to be negative on pathology, or 3) other important differences as judged by the evaluation team including if findings from initial 64CuDOTA-M5A immunoPET imaging could result in modification and adaption of the radiotherapy plan.

Secondary Outcome Measures

Count of Adverse Events.
The frequency and severity of any adverse events possibly related to 64Cu-M5A PET. The toxicity will be graded using the NCI common toxicity scale CTCAE v 5.

Full Information

First Posted
January 11, 2022
Last Updated
October 26, 2022
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05245786
Brief Title
An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Official Title
Pilot Study: Imaging Tumor Extent and Response Before and After Neoadjuvant Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
August 9, 2024 (Anticipated)
Study Completion Date
August 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the Copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A (64Cu labeled M5A antibody) demonstrates a potentially impactful finding for patient management either in the pre-treatment scan (potentially impacting choice of therapy or impacting the radiotherapy [RT] plan) or the scan immediately prior to planned surgery (after standard care [SOC] chemoradiation) in patients with locally advanced rectal cancer. SECONDARY OBJECTIVES: I. To determine the safety of administration of 64Cu labeled M5A antibody. II. To describe/summarize each of the 15 patients' 64Cu-M5A positron emission tomography (PET) imaging findings and corresponding SOC scans and pathology. OUTLINE: Patients receive 64Cu labeled M5A antibody intravenously (IV) over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy. After completion of the study treatment, patients medical records are reviewed up to 2-3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Carcinoma, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (64Cu labeled M5A antibody and imaging)
Arm Type
Experimental
Arm Description
Patients receive 64Cu labeled M5A antibody IV over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy.
Intervention Type
Biological
Intervention Name(s)
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
Other Intervention Name(s)
64Cu-DOTA-M5A, Cu 64-M5A
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Imaging Technique
Other Intervention Name(s)
Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, imaging type, imaging_type, Medical Imaging, Type of imaging
Intervention Description
Undergo imaging
Primary Outcome Measure Information:
Title
Number of patients with impactful finding using 64Cu-M5A positron emission tomography (PET) imaging.
Description
We seek to evaluate the potential for 64Cu-M5A PET imaging in locally advanced rectal cancer before and after neoadjuvant radio-chemotherapy yet prior to planned surgery. Scan findings will be compared to standard of care imaging studies (eg. CT, MRI and FDG PET scans) and biopsy and findings from endoscopy and surgery performed post neoadjuvant CRT therapy. Each of the 15 cases will be reviewed in a protocol team meeting consisting of a radiologist, radiation oncologist, surgeon and pathologist. Cases will be determined by consensus. Examples of "potentially impactful" would be 1) any new lesion not seen on other imaging modalities and confirmed by pathology, 2) a negative 64CuM5A PET on a suspicious lesion by standard of care (SOC) determined to be negative on pathology, or 3) other important differences as judged by the evaluation team including if findings from initial 64CuDOTA-M5A immunoPET imaging could result in modification and adaption of the radiotherapy plan.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Count of Adverse Events.
Description
The frequency and severity of any adverse events possibly related to 64Cu-M5A PET. The toxicity will be graded using the NCI common toxicity scale CTCAE v 5.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus [+]) Patients must be 18 years of age or older The effects of 64Cu-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 a known site of disease. Patients must be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery Patients who are planned for total neoadjuvant therapy where additional chemotherapy is planned before neoadjuvant chemoradiotherapy (CRT) are also eligible Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell 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 Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-M5A Pregnant women are excluded from this study because 64Cu-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 ^64Cu-M5A, breastfeeding should be discontinued if the mother is treated with 64Cu-M5A Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Y Wong
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Y. Wong
Phone
626-256-4673
Email
JWong@coh.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Y. Wong

12. IPD Sharing Statement

Learn more about this trial

An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

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