A Phase I Study of MLN6907 in Patients With Metastatic Colorectal

Inclusion

• Recovery from all adverse effects from prior antitumor therapy to at least Common Terminology Criteria for Adverse Events (CTCAE) (V4.03) Grade 1.Exclusion CriteriaPatients meeting any of the following exclusion criteria are not to be enrolled in the study.
• Known inflammatory bowel disease.
• Inclusion CriteriaEach patient must meet all of the following inclusion criteria to be enrolled in the study:
• Hemoglobin ≥ 9 g/dL.
• Life-threatening illness unrelated to cancer.
• 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.
• 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.
• Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection (testing not required).
• 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.
• Patients must consent to provide the sponsor with tumor tissue samples from their resected liver metastases.
• Male patients who agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the dose of \[68Ga\]MLN6907 or agree to practice true abstinence.
• Adequate renal function as defined in the protocol.
• Clinically significant central nervous system (CNS) metastases.
• History of any hypersensitivity to any component of \[68Ga\]MLN6907.
• Easter Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Must be diagnosed with colorectal cancer (CRC) with liver metastasis and eligible and scheduled for resection of liver metastases as part of their standard of care treatment plan. The planned surgery must occur greater than 14 days after the day of imaging.
• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• Adequate hepatic function as defined in the protocol.
• Suitable venous access for the study-required, blood sampling (ie, including PK sampling)
• Admission or evidence of addictive disorders (eg, illicit drug use, drug abuse, or alcohol abuse) that would limit compliance with study requirements.
• Involvement in an investigative radioactive or other research procedure within 4 weeks prior to administration of \[68Ga\]MLN6907.
• 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.
• Inability to lie flat for the duration of image acquisition.

Exclusion

Exclusion criteria not yet provided.