Clinical Trials Search
Clinical Trial 18205
Cancer Type: Breast
Study Type: Treatment
Phase of Study: Pilot
A Study in Patients Treated with MM-398 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
The primary purpose of this study is to see if the study drug known as MM-398, has an effect on these types of cancer, and if ferumoxytol MRI (Fe-MRI) can be used in participancts taking MM-398 to predict MM-398 activity.
3.1 PRIMARY OBJECTIVES Pilot Phase: In patients with NSCLC, CRC, TNBC, ER/PR positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, GEJ adenocarcinoma or head and neck cancer, who are undergoing therapy with MM-398: *To evaluate the feasibility of delayed ferumoxytol MRI (Fe-MRI) to identify tumor associated macrophages (TAMs). * To measure tumor levels of irinotecan and SN-38. Expansion Phase: In patients with metastatic breast cancer: * To further investigate the feasibility of ferumoxytol (FMX) quantitation in tumor lesions. * To characterize the relationship between ferumoxytol (FMX) tumor uptake and tumor response to MM-398. 3.2 SECONDARY OBJECTIVES Pilot Phase: * To estimate the correlations between Fe-MRI, TAM levels, and tumor levels of irinotecan and SN-38 with administration of MM-398. * To determine the value of Fe-MRI in directing tissue biopsy. All Phases: * To characterize the safety profile of MM-398 in the presence of FMX. * To assess tumor response. * To characterize the pharmacokinetics (PK) of MM-398. Expansion Phase: * To characterize the efficacy of MM-398 in patients with metastatic breast cancer using key efficacy indicators such as objective response rate and clinical benefit rate. * To further characterize the safety profile of MM-398, in the presence of FMX, in metastatic breast cancer patients. * To assess the analytical performance of Fe-MRI measurements and optimize Fe-MRI parameterization. 3.3 EXPLORATORY OBJECTIVES Pilot Phase: * To estimate the correlations between potential pharmacodynamic (PD) markers (Fe-MRI, TAM, tumor irinotecan, tumor SN-38 levels) and safety. * To estimate the correlations between potential PD markers (Fe-MRI, TAM, tumor irinotecan,tumor SN-38 levels) and tumor response.