Actively Recruiting
An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Led by City of Hope Medical Center · Updated on 2025-11-10
15
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months following study participation
- Patients must have a known site of disease and be scheduled for neoadjuvant chemotherapy and radiation therapy followed by surgery
- Patients planned for total neoadjuvant therapy where additional chemotherapy is planned before chemoradiotherapy are eligible
- Results of CT, MRI, FDG PET scans and labs (CBC, CMP) should be available and done within 2 months prior to study entry
- Patients must be able to understand and willing to sign informed consent
- Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to antibody infusion
You will not qualify if you...
- Patients with any uncontrolled illness including ongoing or active infection
- Patients receiving other investigational agents or concurrent biological, chemotherapy, or radiation therapy
- History of allergic reactions to compounds similar to 64Cu-M5A
- Pregnant women are excluded
- Breastfeeding must be discontinued if treated with 64Cu-M5A
- Patients unable to comply with safety monitoring requirements as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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