This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer. Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. The doctors also regularly check the size of the tumour with imaging methods.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
BI 3810944
University of Louisville
Louisville, Kentucky, United States
Tennessee Oncology, PLLC - Elliston Place Plaza DDU
Nashville, Tennessee, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation period
Time frame: approximately 2 months
Part A (dose escalation): Occurrence of Dose Limiting Toxicity (DLTs) during the MTD evaluation period
Time frame: approximately 2 months
Part B (dose expansion): Objective Response (OR)
OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow up or withdrawal of consent
Time frame: up to 24 months
Part A (dose escalation): Occurrence of DLTs during the on-treatment period
Time frame: approximately 2 months
Part A (dose escalation): Occurrence of Adverse Event (AEs) during the on-treatment period
Time frame: approximately 2 months
Part B (dose expansion): Occurrence of AEs during the on-treatment period
Time frame: up to 24 months
Part B (dose expansion): Duration of Response (DoR)
DoR, defined as the time from first documented Complete Response (CR) or Partial Response (PR) until the earliest of Progressive Disease (PD) or death among trial participants with OR according to RECIST v 1.1
Time frame: up to 24 months
Part B (dose expansion): Disease control (DC)
DC, defined as best overall response of confirmed CR, or confirmed PR, or Stable Disease (SD) where best overall response is defined according to RECIST v 1.1 from first treatment administration until the earliest of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent
Time frame: up to 24 months
Part B (dose expansion): Progression-free survival (PFS)
PFS, defined as the time from first administration until tumour progression according to RECIST v 1.1 or death from any cause, whichever occurs earlier
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Maximum measured concentration of BI 3810944 in serum (Cmax)
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Area under the serum concentration-time curve over the time interval from 0 to the last measured time point, tz (AUC0-tz)
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Terminal half-life of BI 3810944 (t1/2)
Time frame: up to 24 months
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