An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination with Standard of Care Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

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
• Patients who have limited metastatic disease who are planned for standard of care chemotherapy and radiotherapy followed by surgical resection of the primary cancer are eligible
• Patients who have already started or finished pre-operative chemotherapy and radiotherapy and are waiting for planned surgery are also eligible. These patients would only receive one Cu64-M5A PET scan after completion of radiotherapy and prior to planned surgery
• 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

Exclusion Criteria

• 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 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