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This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 (Brigimadlin) in Patients With Advanced or Metastatic Solid Tumors

NCT03449381•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
•Pathologically documented, advanced solid tumors.
•Patients fulfilling one or more of the following criteria:
•* Radiologically documented disease progression or relapse

Exclusion Criteria

•* Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
•Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria to be considered eligible.
•Phase Ia (dose escalation) only:
•Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
•Phase Ib (expansion phase) only:
•Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included if agreed between the Investigator and Sponsor.
•Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
•Phase Ia (dose escalation) only:
•Patient with either measurable or non-measurable disease.
•Non-evaluable disease allowed.
+14 more criteria

Locations (27)

Sarcoma Oncology Center

Santa Monica, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Florida Cancer Specialists-Sarasota-61670

Sarasota, Florida, United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States

START Midwest

Grand Rapids, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Key Dates

Start Date

June 20, 2018

Primary Completion Date

November 13, 2025

Completion Date

November 13, 2025

Last Updated

November 26, 2025

Enrollment

266

ACTUAL participants

Conditions

Neoplasms

Interventions

BI 907828

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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