First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Intravenous administration
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
University College London NHS Foundation Trust
London, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom
To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553
First-cycle dose limiting toxicities (DLT)
Time frame: 28 day cycles
To evaluate safety and tolerability of BAL101553 treatment
Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments
Time frame: 28 day cycles
To evaluate BAL101553 pharmacokinetics
BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution
Time frame: 28 day cycles
To assess anti-tumor activity of BAL101553
Response rate per RECIST guidelines
Time frame: 28 day cycles
To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553
Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers
Time frame: 28 day cycles
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