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

Phase 2

Recruiting

• Conditions: Solid Tumours
• Interventions: Drug: Brigimadlin

• Registration Number: NCT06619509
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-12-30
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-14
• Last Update Posted: 2025-10-15
• Primary Completion: 2030-12-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brigimadlin	Brigimadlin	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period	up to 9 years.	CTCAE=Common Terminology Criteria for Adverse Events

Trial Locations

Locations (50)

Precision NextGen Oncology; 🇺🇸 Beverly Hills, California, United States

Sarcoma Oncology Center; 🇺🇸 Santa Monica, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States

Nebraska Cancer Specialists-Omaha-69066; 🇺🇸 Omaha, Nebraska, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

West Cancer Center & Research Institute; 🇺🇸 Germantown, Tennessee, United States

Henry-Joyce Cancer Clinic; 🇺🇸 Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Scroll for more (40 remaining)