Cancer Clinical Trial
Official title:
Phase I/Ib Trial of Single Agent MBF-362 in Solid Tumors
This is an open, single center Phase Iclinical trial to evaluate the safety, tolerability, and preliminary efficacy of MBF-362 in patients with solid tumors.
The phase I dose escalation will be conducted utilizing the standard 3+3 dose escalation method. Pharmacokinetic (PK) data will be obtained for MBF-362. The phase I dose expansion will consist of 1 group including solid tumors cancer patients. Pharmacodynamic (PD) data will be obtained for potential biomarker analysis with pre-treatment and on-treatment tumor biopsies. Phase I Dose Escalation (3+3 Design): the MTD will be defined as the highest dose level at which less than 2 out of 6 patients (<33%) experience DLT in Cycle 1 (first 28 days). Phase I Safety Expansion once RP2D has been declared for MBF-362 using the standard 3+3 design, up to 20 additional solid tumor cancer patients may be treated at the RP2D to further explore safety and tolerability of the selected MBF-362 dose. Patients must have histologically or cytologically confirmed cancer with at least one measurable lesion, with adequate organ and marrow function, and with ECOG performance status of 0-1. Eligible patients must have received at least one prior line of therapy for their disease. ;
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