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)

Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors

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.

Study Overview

• Status: Suspended
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: BI 1831169; Drug: anti-PD-1 antibody

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula Haematology & Oncology
• Austria
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
  • Salzburg, Austria, 5020
    • Salzburg Cancer Research Institute
• Belgium
  • Edegem, Belgium, 2650
    • Edegem - UNIV UZ Antwerpen
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• France
  • Bordeaux, France, 33000
    • INS Bergonie
  • Marseille, France, 13385
    • HOP Timone
  • Rennes, France, 35042
    • CTR Eugène Marquis
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Spain
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital Duran i Reynals
  • Madrid, Spain, 28040
    • Fundación Jiménez Díaz
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospital Geneva
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center-Gilbert-55251
    • Tucson, Arizona, United States, 85719
      • University of Arizona
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Santa Monica, California, United States, 90404
      • Providence St. John's Health Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Further inclusion criteria apply.

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))
• Chronic steroid use, regardless of daily dose Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 (Monotherapy): Arm A	Drug: BI 1831169; BI 1831169
Experimental: Part 1 (Monotherapy): Arm B	Drug: BI 1831169; BI 1831169
Experimental: Part 1 (Monotherapy): Arm C	Drug: BI 1831169; BI 1831169
Experimental: Part 2 (Combination therapy): Arm D	Drug: BI 1831169; BI 1831169; Drug: anti-PD-1 antibody; anti-PD-1 antibody
Experimental: Part 2 (Combination therapy): Arm E	Drug: BI 1831169; BI 1831169; Drug: anti-PD-1 antibody; anti-PD-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)	BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment. BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first).	up to 49 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period		up to 49 months
Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period		up to 49 months
Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)	DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR.	up to 49 months
Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)	DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment.	up to 49 months
Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)	PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST.	up to 4 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immunologic Factors; Physiological Effects of Drugs; spartalizumab
• Other Study ID Numbers: 1456-0001; 2020-003902-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No