Clinical trial · Interventional
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
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
NCT01770353CI-TRIAL-00041975completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER/PR Positive Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer With Active Brain Metastasis | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol | Drug | — | UNRESOLVED |
| MM-398 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pilot Phase: Ferumoxytol followed by MM-398
- description
- Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min on Days 1 and 15 of every 4 week cycle
- interventionNames
- Drug: Ferumoxytol
- Drug: MM-398
- type
- EXPERIMENTAL
- label
- Expansion Phase: Ferumoxytol followed by MM-398
- description
- Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min dose 1 on Days 1 and 15 of every 4 week cycle Cohort 1: ER and/or PR-positive BC Cohort 2: TNBC Cohort 3: BC with active brain metastasis
- interventionNames
- Drug: Ferumoxytol
- Drug: MM-398
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRavi H, Arias-Lorza AM, Costello JR, Han HS, Jeong DK, Klinz SG, Sachdev JC, Korn RL, Raghunand N. Pretherapy Ferumoxytol-enhanced MRI to Predict Response to Liposomal Irinotecan in Metastatic Breast Cancer. Radiol Imaging Cancer. 2023 Mar;5(2):e220022. doi: 10.1148/rycan.220022. PMID 36734848
- DERIVEDSachdev JC, Munster P, Northfelt DW, Han HS, Ma C, Maxwell F, Wang T, Belanger B, Zhang B, Moore Y, Thiagalingam A, Anders C. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase. Breast Cancer Res Treat. 2021 Feb;185(3):759-771. doi: 10.1007/s10549-020-05995-7. Epub 2020 Nov 17. PMID 33201358