A Phase I Study of MLN6907 in Patients With Metastatic Colorectal

Exclusion Criteria

• •Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of \[68Ga\]MLN6907.
• •Any serious medical or psychiatric illness, condition, or personal circumstance, including severe claustrophobia, severe dyspnea, severe back pain, etc., that, in the judgment of the investigator or project clinician, might potentially interfere with the procedures required in this study.
• •Involvement in an investigative radioactive or other research procedure within 4 weeks prior to administration of \[68Ga\]MLN6907.
• •Major surgery within 14 days prior to administration of \[68Ga\]MLN6907 5. Serious infection (viral, bacterial, or fungal) within 14 days before administration of \[68Ga\]MLN6907 or evidence of active infection during screening.
• •Life-threatening illness unrelated to cancer.
• •Clinically significant central nervous system (CNS) metastases.
• •Known inflammatory bowel disease.
• •Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection (testing not required).
• •History of any hypersensitivity to any component of \[68Ga\]MLN6907.
• •Symptomatic cardiac disease, including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator or project clinician, interfere with assessment of efficacy or safety of \[68Ga\]MLN6907.
• •Admission or evidence of addictive disorders (eg, illicit drug use, drug abuse, or alcohol abuse) that would limit compliance with study requirements.
• •Inability to lie flat for the duration of image acquisition.