Actively Recruiting
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)
Led by Boehringer Ingelheim · Updated on 2026-05-12
190
Participants Needed
40
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically or cytologically confirmed advanced, unresectable, metastatic, or relapsed/refractory solid tumors
- At least one or two accessible lesions suitable for injection and/or biopsy
- Lesions must be easily accessible or patient must agree to repeated procedures for biopsies and injections
- Patients who have failed conventional treatments or have no effective therapy options available
- Life expectancy of at least 3 months after starting study treatment
You will not qualify if you...
- Prior treatment with Vesicular stomatitis virus (VSV)-based agents
- Use of medications or health conditions that pose high risks for injection or biopsy complications
- Presence of brain metastases
- Infection with HIV meeting certain criteria, active autoimmune disease, or chronic active Hepatitis B or C infection
- Ongoing use of chronic steroids regardless of dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Banner MD Anderson Cancer Center-Gilbert-55251
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of California San Diego
La Jolla, California, United States, 92037
Completed
4
Providence St. John's Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
5
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
7
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
8
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
9
University of Louisville
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
10
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
12
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
13
Prisma Health
Greenville, South Carolina, United States, 29605
Not Yet Recruiting
14
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5062
Not Yet Recruiting
16
Peninsula Haematology & Oncology
Frankston, Victoria, Australia, 3199
Actively Recruiting
17
Medical University of Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
18
Salzburg Cancer Research Institute
Salzburg, Austria, 5020
Completed
19
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
20
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Not Yet Recruiting
21
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
22
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
23
INS Bergonie
Bordeaux, France, 33000
Actively Recruiting
24
HOP Timone
Marseille, France, 13385
Actively Recruiting
25
CTR Eugène Marquis
Rennes, France, 35042
Completed
26
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
27
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Not Yet Recruiting
28
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
29
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
30
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
31
Istituto Di Candiolo
Candiolo (TO), Italy, 10060
Not Yet Recruiting
32
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Not Yet Recruiting
33
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Not Yet Recruiting
34
Hospital Quiron. I.C.U.
Barcelona, Spain, 08023
Not Yet Recruiting
35
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
36
Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
37
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
38
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Not Yet Recruiting
39
University Hospital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
40
University Hospital Geneva
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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