for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Pamela Munster



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.

Official Title

A Phase I Study in Patients Treated With 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


This study is conducted over two phases. The pilot phase of this trial is closed. The expansion phase of this trial has completed enrolment, patients are still ongoing.

Pilot Phase: This study will enroll approximately 12 patients, up to 20 in total in the Pilot Phase and 30 patients in the Expansion Phase. The first three patients that are enrolled in the Pilot Phase can have any solid tumor type; however subsequent patients must have Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Triple negative breast cancer (TNBC), Estrogen Receptor/Progesterone Receptor (ER/PR) positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastro-oesophageal junction adenocarcinoma or head and neck cancer. No more than three patients with ER/PR positive breast cancer can be enrolled in the Pilot Phase and similar restrictions may be placed on other tumor types to ensure a heterogeneous population.

Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts of 10 patients each depending on sub-type of breast cancer:

Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis


Solid Tumors ER/PR Positive Breast Cancer Triple Negative Breast Cancer Metastatic Breast Cancer With Active Brain Metastasis Colorectal Cancer MM-398 nanoliposomal irinotecan Ferumoxytol Pancreatic Cancer Ovarian Cancer Gastric Cancer Gastro-Esophageal Junction Adenocarcinoma Head and Neck Cancer TNBC Breast Neoplasms Triple Negative Breast Neoplasms Irinotecan Camptothecin Ferrosoferric Oxide


You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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


  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94115 United States
  • HonorHealth
    Scottsdale Arizona 85258 United States
  • Mayo Clinic
    Scottsdale Arizona 85159-5499 United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 1
Lead Scientist
Pamela Munster
Study Type
Last Updated
August 23, 2018