NCT06619509

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine

A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer. All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Brigimadlin	Brigimadlin

Timeline

• Start date: 2024-12-30
• Primary completion: 2030-12-30
• Completion: 2030-12-30
• First posted: 2024-10-01
• Last updated: 2026-04-14

Locations

50 sites across 20 countries: United States, Argentina, Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study