This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer. One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Solution for infusion
University of Southern California
Los Angeles, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
Erasmus MC Kanker Instituut
Rotterdam, Netherlands
Hospital Vall d'Hebron
Barcelona, Spain
Number of Participants With Dose Limiting Toxicities (DLTs)
The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.
Time frame: In the first treatment cycle, up to 3 weeks
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.
Time frame: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.
Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)
The Maximum measured concentration of BI 905677 in serum after first infusion is reported.
Time frame: 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)
The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported.
Time frame: 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
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