This Study Aims to Find the Best Dose of BI 907828 in Patients With Different Types of Advanced Cancer (Solid Tumours)

Official Title

A Phase Ia/Ib, Open Label, Multicentre, Dose-escalation Study of BI 907828 in Patients With Advanced or Metastatic Solid Tumours

Summary:

This study is open to adults with different types of advanced cancer (solid tumours). The purpose of this study is to find out the highest dose of BI 907828 the participants can tolerate. In the second part, the study also tests whether BI 907828 makes tumours shrink. In this study, BI 907828 is given to humans for the first time. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. BI 907828 is taken as a tablet. Participants either take a dose of BI 907828 on one day every 3 weeks or on one day in 2 consecutive weeks every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

Trial Description

Primary Outcome:

• Phase Ia- MTD based on number of patients with DLTs during first treatment cycle
• Ph Ib - Objective response per RECIST, RANO criteria, or RANO-BM, and assessed by Investigator, measured separately for each cohort, from treatment start until earliest of progression, death, or last tumour assessment and before subsequent therapy
• Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)

• Phase Ia- Cmax: maximum measured concentration of BI 907828 in plasma
• Phase Ia - AUC0-∞: area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity.
• Phase Ib - Disease control (DC) with tumour assessment until disease progression (according to RECIST v.1.1 for non-brain lesions, or RANO/RANO-BM- criteria for brain lesions) as assessed by the Investigator, or start of subsequent anti-cancer treatment
• Phase Ib - Progression-free Survival defined from date of start of BI 907828 to earliest of date of disease progression or death (according to RECIST 1.1, RANO/RANO-BM as applicable), as assessed by the Investigator, measured separately for each cohort.
• Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period.
• Phase Ib - Cmax: maximum measured concentration of BI 907828 in plasma
• Phase Ib - AUC0-∞: area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

View this trial on ClinicalTrials.gov