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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)

NCT ID: NCT05155332

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2028-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 (Monotherapy): Arm A

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

Part 1 (Monotherapy): Arm B

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

Part 1 (Monotherapy): Arm C

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

Part 2 (Combination therapy): Arm D

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

anti-PD-1 antibody

Intervention Type DRUG

anti-PD-1 antibody

Part 2 (Combination therapy): Arm E

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

anti-PD-1 antibody

Intervention Type DRUG

anti-PD-1 antibody

Part 2 (Combination therapy): Arm F

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

anti-PD-1 antibody

Intervention Type DRUG

anti-PD-1 antibody

Part 2 (Combination therapy): Arm G

Group Type EXPERIMENTAL

BI 1831169

Intervention Type DRUG

BI 1831169

anti-PD-1 antibody

Intervention Type DRUG

anti-PD-1 antibody

Interventions

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BI 1831169

BI 1831169

Intervention Type DRUG

anti-PD-1 antibody

anti-PD-1 antibody

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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))
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner MD Anderson Cancer Center-Gilbert-55251

Gilbert, Arizona, United States

Site Status RECRUITING

University of Arizona

Tucson, Arizona, United States

Site Status NOT_YET_RECRUITING

University of California San Diego

La Jolla, California, United States

Site Status NOT_YET_RECRUITING

Providence St. John's Health Center

Santa Monica, California, United States

Site Status RECRUITING

University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status RECRUITING

Winship Cancer Institute

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

University of Louisville

Louisville, Kentucky, United States

Site Status NOT_YET_RECRUITING

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Prisma Health

Greenville, South Carolina, United States

Site Status NOT_YET_RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Site Status NOT_YET_RECRUITING

Peninsula Haematology & Oncology

Frankston, Victoria, Australia

Site Status NOT_YET_RECRUITING

Medical University of Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Salzburg Cancer Research Institute

Salzburg, , Austria

Site Status NOT_YET_RECRUITING

Edegem - UNIV UZ Antwerpen

Edegem, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

INS Bergonie

Bordeaux, , France

Site Status RECRUITING

HOP Timone

Marseille, , France

Site Status RECRUITING

CTR Eugène Marquis

Rennes, , France

Site Status RECRUITING

INS Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Charite Universitätsmedizin Berlin KöR

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Istituto Di Candiolo

Candiolo (TO), , Italy

Site Status NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status NOT_YET_RECRUITING

Hospital Quiron. I.C.U.

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Duran i Reynals

L'Hospitalet de Llobregat, , Spain

Site Status RECRUITING

Fundación Jiménez Díaz

Madrid, , Spain

Site Status RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Instituto Valenciano de Oncología

Valencia, , Spain

Site Status NOT_YET_RECRUITING

University Hospital Bern

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

University Hospital Geneva

Geneva, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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United States Australia Austria Belgium Canada France Germany Italy Spain Switzerland

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

References

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Porosnicu M, Quinson AM, Crossley K, Luecke S, Lauer UM. Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors. Future Oncol. 2022 Aug;18(24):2627-2638. doi: 10.2217/fon-2022-0439. Epub 2022 Jun 14.

Reference Type DERIVED
PMID: 35699077 (View on PubMed)

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2020-003902-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1456-0001

Identifier Type: -

Identifier Source: org_study_id