Stopped: Not due to safety reasons.
The main objective of the dose-escalation parts of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for further development of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety and tolerability by monitoring the occurrence and severity of adverse events (AEs). Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary assessment of anti-tumour activity.
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Part A - Maximum Tolerated Dose (MTD) of BI 891065
Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.
Part A - Number of Patients With Dose-limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period
Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.
Part B: Maximum Tolerated Dose (MTD) of BI 891065 in Combination With Ezabenlimab
Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.
Part B: Number of Patients With Dose-limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period
Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.