A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)
Summary
This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer. Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study. Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.
Arms & interventions
- DrugBI 3819026
BI 3819026
- DrugEzabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Outcome measures
Primary
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Time frame: Up to 30 days
Secondary
Occurrence of adverse events (AEs) with onset during the on-treatment period
Time frame: Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Time frame: Up to 2 years
Occurrence of AEs with onset during Cycle 1
Time frame: Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Time frame: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Time frame: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Time frame: Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Time frame: Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1
Time frame: Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Time frame: Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Time frame: Up to Day 30
Treatment-induced changes in target cells as compared with baseline
Time frame: At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Time frame: At baseline and up to 2 years
Eligibility criteria
Study locations (4)
Yale Cancer Center
New Haven, Connecticut, 06511
Hackensack University Medical Center
Hackensack, New Jersey, 07601
New York University Langone Medical Center
New York, New York, 10016
SCRI Oncology Partners
Nashville, Tennessee, 37203