NCT05613036

A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body

An Open-label, Non-randomized Phase I Investigation of Human ADME (Absorption, Distribution, Metabolism and Excretion) and Absolute Oral Bioavailability of BI 907828 in Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful or no treatment exists can take part. This study tests a medicine called BI 907828. BI 907828 is a so-called p53-MDM2 antagonist that is being developed to treat cancer. The purpose of the study is to find out how BI 907828 is processed in the body. In the first 3 weeks, participants therefore get a single dose of BI 907828 in a labelled form. The first participants take BI 907828 as a liquid. This is to find out how much BI 907828 is taken up in the body when it is taken by mouth. Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet. This is to find out how long BI 907828 stays in the blood. After the first 3 weeks, all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it. During the study, participants visit the study site regularly. Some of the study visits include staying overnight. At the beginning, some of the participants stay at the study site for 15 nights. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)	\[¹⁴C\]-BI 907828 mixed with BI 907828 (formulation 1)
DRUG	[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)	\[¹⁴C\]-BI 907828 mixed with BI 907828 (formulation 2)
DRUG	BI 907828	BI 907828

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-04-25
• Completion: 2025-01-13
• First posted: 2022-11-14
• Last updated: 2025-01-22

Locations

1 site across 1 country: Hungary