The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
* Dosing every 2 weeks * Intravenous injection
* Dosing weekly * Intravenous injection
Scottsdale Healthcare
Scottsdale, Arizona, United States
Florida Cancer Specialists / Sarah Cannon Research Institute
Sarasota, Florida, United States
Department of Investigator Cancer Therapeutics, University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Cancer Therapy and Research Center (CTRC), The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Time frame: 14 months
Plasma pharmacokinetic parameters
Maximum concentration (Cmax), minimum concentration (Cmin), area under the concentration vs time curve (AUC), half-life \[t½\], clearance (CL), mean residence time (MRT) and volume of distribution at steady state (VDss)
Time frame: 28 days
Tumor response
Time frame: 14 months
Levels of free active MIF and free total MIF in plasma and tumor tissue (where applicable)
Time frame: 14 months
Change in levels of tumor-associated biomarkers, if applicable based on cancer type, following treatment with anti-MIF antibody
Time frame: 14 months
Number of serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality
Time frame: 14 Months
Number of participants experiencing related serious adverse events (SAEs) and/or adverse events (AEs)
Time frame: 14 months
Number of related serious adverse events (SAEs) and/or adverse events (AEs)
Time frame: 14 months
Number of dose limiting toxicities (DLTs)
Time frame: 14 months
Number of participants experiencing dose limiting toxicity (DLT)
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Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany
Time frame: 14 months
Number of participants who develop binding and/or neutralizing anti-anti-macrophage migration inhibitory factor (anti-MIF) antibodies following treatment with anti-MIF
Time frame: 14 months
Anti-MIF antibody in tumor tissues, bound and/or unbound to active MIF (where applicable)
Time frame: 14 Months
Levels of other potential biomarkers in tumor tissue (where applicable)
Time frame: 14 Months