MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

Inclusion Criteria

• Inclusion Criteria: All subjects: - Pathologically confirmed diagnosis of solid tumors - Metastatic disease - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 - Adequate bone marrow, hepatic and renal function - Normal Electrocardiogram (ECG) - 18 years of age or above - Able to understand and sign informed consent Pilot study only: - CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer Expansion Phase Additional Criteria: - Locally advanced or metastatic breast cancer - Received at least one cytotoxic therapy in the locally advanced and metastatic setting - Received ≤ 5 prior lines of chemotherapy in the metastatic setting - Candidate for chemotherapy Expansion Phase Cohort 3 additional inclusion criteria: - Breast cancer with active brain metastasis - Neurologically stable Exclusion Criteria: - Active Central nervous system (CNS) metastasis (applies to pilot phase and expansion phase cohort 1 and 2 only) - Clinically significant GI disorders - Prior irinotecan or bevacizumab therapy within last 6 months and for Expansion Phase patients, have received any prior treatment with Topol inhibitor - Known hypersensitivity to MM-398 or ferumoxytol - Inability to undergo MRI - Active infection - Pregnant or breast feeding - Prior chemotherapy administered within 3 weeks, or within a time interval less than at least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day of dosing in this study - Received radiation therapy in the last 14 days - Treated with parenteral iron in the previous 4 weeks