Kantonsspital St.Gallen

An open-label Phase 1/2a study of BAL101553 adminis-tered as 48-hour intravenous infusions in adult patients with advanced solid tumors

Markus Joerger

abstract The primary objectives of this study are to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of BAL101553, administered as an intravenous (IV) infusion over 48 hours on study Days 1, 8 and 15 of a 28-day treatment cycle, to adults with ad-vanced or recurrent solid tumors who have failed standard therapy or for whom no effective standard therapy is avail-able. Secondary objectives: To evaluate the safety and tolerabil-ity of BAL101553 administered as a 48-hour continuous IV infusion. To assess the anti-tumor activity of BAL101553 adminis-tered as a 48-hour continuous IV infusion. To assess the bioavailability of daily oral BAL101553 when administered on study Days 15–21 of Cycle 2. Exploratory objectives: To assess the use of biomarkers to characterize the phar-macodynamic effects of BAL101553,administered as a 48-hour continuous IV infusion. To explore the potential utility of biomarkers in blood and/or tumor tissue as predictive biomarkers.
type of project clinical studies
status ongoing - recruiting phase
start of project 2016
end of project 2018
study design Phase I / II
responsible person PD Dr. med. Markus J├Ârger