The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905681. The MTD will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD/DLT evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for Schedule A and Schedule B. The secondary objective of the trial is to determine the pharmacokinetic (PK) profile of BI 905681.
Study was opened to recruitment until 29-Oct-2021, however from 15-Apr-2021 no patient was recruited.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Infusion
Florida Cancer Specialists
Sarasota, Florida, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Maximum Tolerated Dose (MTD)/Optimal Biological Dose (OBD) of BI 905681
The MTD/OBD of BI 905681. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, in the first cycle of treatment (3 weeks). The MTD is defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Time frame: The first cycle of treatment, up to 21 days.
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
Number of patients experiencing adverse events (AEs) during the entire treatment period.
Time frame: From the first administration of study till the last administration of study drug +42 days, up to 126 days.
Cmax: Maximum Measured Concentration of BI 905681 in Serum After First Infusion
Cmax: maximum measured concentration of BI 905681 in serum after first infusion.
Time frame: 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.
AUC0-tz: Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (tz)
AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz).
Time frame: 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.
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