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)

NCT05155332 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1456-00012020-003902-30
• Study Type: interventional
• Target: 190
• Locations: 9 countries
• Sites: 38

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period

  Part 1 (Monotherapy).

  up to 21 days

• Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)

  BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

  up to 49 months

• Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period

  Part 2 (Combination Therapy).

  up to 21 days

• Part 2.2, Dose Expansion, Arm D: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)

  BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

  up to 49 months

• Part 2.2, Dose Expansion, Arm E, Arm F, Arm G: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed immunotherapy partial response (iPR)

  BOR is defined according to Response Criteria for intravenous Immunotherapy in Solid Tumors (iRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

  up to 49 months

Secondary Outcomes (12)

• Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

  up to 49 months

• Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

  up to 49 months

• Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period

  up to 49 months

• Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period

  up to 49 months

• Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

  up to 49 months

Study Arms (7)

Part 1 (Monotherapy): Arm A

EXPERIMENTAL

Drug: BI 1831169

Part 1 (Monotherapy): Arm B

EXPERIMENTAL

Drug: BI 1831169

Part 1 (Monotherapy): Arm C

EXPERIMENTAL

Drug: BI 1831169

Part 2 (Combination therapy): Arm D

EXPERIMENTAL

Drug: BI 1831169; Drug: anti-PD-1 antibody

Part 2 (Combination therapy): Arm E

EXPERIMENTAL

Drug: BI 1831169; Drug: anti-PD-1 antibody

Part 2 (Combination therapy): Arm F

EXPERIMENTAL

Drug: BI 1831169; Drug: anti-PD-1 antibody

Part 2 (Combination therapy): Arm G

EXPERIMENTAL

Drug: BI 1831169; Drug: anti-PD-1 antibody

Interventions

anti-PD-1 antibody DRUG

anti-PD-1 antibody

Part 2 (Combination therapy): Arm D; Part 2 (Combination therapy): Arm E; Part 2 (Combination therapy): Arm F; Part 2 (Combination therapy): Arm G

BI 1831169 DRUG

BI 1831169

Part 1 (Monotherapy): Arm A; Part 1 (Monotherapy): Arm B; Part 1 (Monotherapy): Arm C; Part 2 (Combination therapy): Arm D; Part 2 (Combination therapy): Arm E; Part 2 (Combination therapy): Arm F; Part 2 (Combination therapy): Arm G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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))

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (40)

Banner MD Anderson Cancer Center-Gilbert-55251

Gilbert, Arizona, 85234, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

University of California San Diego

La Jolla, California, 92037, United States

COMPLETED

Providence St. John's Health Center

Santa Monica, California, 90404, United States

RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

RECRUITING

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5062, Australia

NOT YET RECRUITING

Peninsula Haematology & Oncology

Frankston, Victoria, 3199, Australia

NOT YET RECRUITING

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Salzburg Cancer Research Institute

Salzburg, 5020, Austria

COMPLETED

Edegem - UNIV UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

INS Bergonie

Bordeaux, 33000, France

RECRUITING

HOP Timone

Marseille, 13385, France

RECRUITING

CTR Eugène Marquis

Rennes, 35042, France

COMPLETED

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

NOT YET RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Istituto Di Candiolo

Candiolo (TO), 10060, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

NOT YET RECRUITING

Hospital Quiron. I.C.U.

Barcelona, 08023, Spain

NOT YET RECRUITING

Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, 46009, Spain

NOT YET RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

University Hospital Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35699077 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

spartalizumab

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 13, 2021
• Study Start: March 28, 2022
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); AU (2); CA (1); US (14); DE (4); ES (5); CH (2); IT (3); FR (4)