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

Running, not enrolling · Phase 2

Conditions studied: Solid Tumours

In brief

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.

Key facts

Study ID: NCT06619509
Run by: Boehringer Ingelheim
People needed: 90
Starts: 2024-12-30
Expected to finish: 2030-12-30
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of <1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
Adequate organ function.
Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.

You may not qualify if…

Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor.
Further exclusion criteria apply.

Where it is running

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
Utah Cancer Specialists Cancer Center — Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
University of Wisconsin — Madison, Wisconsin, United States
Sanatorio Finochietto — CABA, Argentina
Prince of Wales Hospital-Randwick-66496 — Randwick, New South Wales, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Cliniques Universitaires Saint-Luc — Brussels, Belgium
UZ Leuven — Leuven, Belgium
Arthur J. E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
Princess Margaret Cancer Centre — Toronto, Ontario, Canada
Sun Yat-Sen University Cancer Center — Guangzhou, China
University Hospital Olomouc — Olomouc, Czechia
Copenhagen University Hospital, Rigshospitalet — København Ø, Denmark
CTR Leon Berard — Lyon, France
CTR Eugène Marquis — Rennes, France

Full record on ClinicalTrials.gov

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