A Phase I, Open Label, Multicenter, Dose-escalation Study of BI 907828 in Adult Patients With Wild-type TP53 Enriched Advanced Solid Tumors and Expansion in Patients With MDM2 Amplified Advanced Solid Tumors

Phase Ia - The main objective of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose limiting toxicities (DLT) during the first treatment cycle, and the recommended dose for expansion (RDE) of BI 907828 monotherapy, and to evaluate its safety and tolerability, by monitoring the occurrence and severity of adverse events (AEs), in two different schedules (Arm A with one single dose every 21 days, Arm B with one single dose on Days 1 and 8, every 28 days).

The secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 907828 monotherapy, and the preliminary assessment of anti-tumor activity in patients with advanced or metastatic solid tumors.

Phase Ib - In the expansion cohorts of the trial, the main objectives are to assess efficacy, and to further assess the safety, and PK profiles at the RDE, and determine the recommended Phase 2 dose (RP2D).