A study in patients with different types of advanced cancer (solid tumors) to test different doses of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 or BI 907828 in combination with BI 754091 (ezabenlimab)
- Conditions
- advanced solid tumor
- Registration Number
- JPRN-jRCT2080224759
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 170
1. Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
2. ECOG performance status of 0 or 1.
3. Patient must be willing to submit to the blood sampling for the PK, PD, and tumor mutation analysis
1. Patients who have been treated with any other anticancer drug other than antibodies within 4 weeks or within 5 half-life periods (whichever come earlier) prior to first administration of trial medication.
2. Persistent toxicity from previous treatments that has not resolved to CTCAE Grade 1.
3. Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase Ia - maximum tolerated dose (MTD) of BI 907828 in combination with ezabenlimab based on the number of patients with dose limiting toxicities (DLTs) during the first treatment cycle [ Time Frame: Up to 21 Days ]<br>Phase Ib - Objective response (OR) [ Time Frame: Up to 24 months ]<br>Phase Ib - Progression free survival [ Time Frame: Up to 24 months ]
- Secondary Outcome Measures
Name Time Method Phase Ia - Cmax: Maximum measured plasma concentration of BI 907828 and ezabenlimab (during the first cycle) [ Time Frame: Up to 21 Days ]<br>Phase Ia - AUC0-tz: Area under the concentration-time curve in plasma for BI 907828 and ezabenlimab over the time interval from 0 to the last quantifiable time point (during the first cycle) [ Time Frame: Up to 21 Days ]<br>Phase Ia - Number of patients with DLTs observed during the entire treatment period [ Time Frame: Up to 24 months ]<br>Phase Ib - Objective Response (OR) [ Time Frame: Up to 24 months ]<br>Phase Ib - Disease control (DC) [ Time Frame: Up to 24 months ]<br>Phase Ib - Number of patients with DLTs [ Time Frame: Up to 2 years ]<br>Phase Ib - Overall survival (OS) [ Time Frame: Up to 24 months ]