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
Condition: Solid Tumors; ER/PR Positive Breast Cancer; Triple Negative Breast Cancer; Metastatic Breast Cancer With Active Brain Metastasis
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Brain Neoplasms
Intervention: Ferumoxytol; MM-398
Intervention description: Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.; MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: solid tumors; Triple Negative Breast Cancer; Colorectal Cancer; MM-398; nanoliposomal irinotecan; Ferumoxytol; ER/PR positive Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Gastric Cancer; Gastro-Esophageal Junction Adenocarcinoma; Head and Neck Cancer; TNBC

Summary:

      This is a Phase I study to understand the biodistribution of MM-398 and to determine the
      feasibility of using Ferumoxytol as a tumor imaging agent.
    

Eligibility 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