This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or other selected solid tumors or hematologic malignancies. The drug is given intravenously, for 5 days in a row and then two weeks off.
This is a Phase I, open-label, multicenter, dose-escalation study to investigate the safety, Pharmacokinetics and Pharmacodynamics of the micro ribonucleic acid (microRNA) MRX34, in patients with unresectable primary liver cancer or advanced or metastatic cancer with or without liver involvement or hematologic malignancies. MRX34 will be administered daily x 5 with 2 weeks off (total of 21 days) for 3 cycles followed by a no-treatment observation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
micro RNA therapy
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Texas Oncology Dallas
Dallas, Texas, United States
UT Southwestern Medical Center
The maximum tolerated dose (MTD) for MRX34 and the recommended phase 2 dose (RPh2D)
Dose-limiting toxicity (DLT) in 3-6 patients at the end of one treatment cycle
Time frame: 18 months
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing
Time frame: 18 months
Number of patients with evidence of clinical activity of MRX34
Time frame: 18 months
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Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Uthscsa/Ctrc
San Antonio, Texas, United States
Severance Hospital, Yonsie University Health System
Seoul, Seodaemun-Gu, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea