Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05155332

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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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) | DecenTrialz