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)

Paused · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID: NCT05155332
Run by: Boehringer Ingelheim
People needed: 190
Starts: 2022-03-28
Expected to finish: 2028-10-31
Last updated by the study team: 2026-08-07

Who can join

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

You may qualify if…

Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.
Further inclusion criteria apply.

You may not qualify if…

Previous treatment with Vesicular stomatitis virus (VSV)-based agents
Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
Presence of brain metastases
Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
Chronic steroid use, regardless of daily dose Further exclusion criteria apply.

Where it is running

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
Orlando Health Cancer Institute — Orlando, Florida, 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
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Peninsula Haematology & Oncology — Frankston, Victoria, Australia
Medical University of Innsbruck — Innsbruck, Austria
Salzburg Cancer Research Institute — Salzburg, Austria
Universitair Ziekenhuis Antwerpen — Edegem, 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
Universitätsklinikum Tübingen — Tübingen, Germany
Universitätsklinikum Ulm — Ulm, Germany
Istituto Di Candiolo — Candiolo (TO), Italy
Hospital Duran i Reynals — L'Hospitalet de Llobregat, Spain
Fundación Jiménez Díaz — Madrid, Spain

Full record on ClinicalTrials.gov

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