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A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
Official title: Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2022-03-28
Completion Date
2028-10-31
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
BI 1831169
BI 1831169
anti-PD-1 antibody
anti-PD-1 antibody
Locations (40)
Banner MD Anderson Cancer Center-Gilbert-55251
Gilbert, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
Providence St. John's Health Center
Santa Monica, California, United States
University of Colorado Denver
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Peninsula Haematology & Oncology
Frankston, Victoria, Australia
Medical University of Innsbruck
Innsbruck, Austria
Salzburg Cancer Research Institute
Salzburg, Austria
Edegem - UNIV UZ Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
INS Bergonie
Bordeaux, France
HOP Timone
Marseille, France
CTR Eugène Marquis
Rennes, France
Institut Gustave Roussy
Villejuif, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Istituto Di Candiolo
Candiolo (TO), Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Hospital Quiron. I.C.U.
Barcelona, Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Fundación Jiménez Díaz
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Instituto Valenciano de Oncología
Valencia, Spain
University Hospital Bern
Bern, Switzerland
University Hospital Geneva
Geneva, Switzerland