AzTrials
AzTrials

Solid TumorsPhase 1NCT05155332

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)

A Phase 1 study testing BI 1831169 and anti-PD-1 antibody in people with Solid Tumors, run by Boehringer Ingelheim at 33 sites in 10 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
BI 1831169 and anti-PD-1 antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
33 sitesin 10 countries
Study dates
28 Mar 2022to 31 Oct 2028
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 10 countries.

33 sites in 10 countries

United States15 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Banner MD Anderson Cancer Center-Gilbert-55251

    Gilbert, Arizona, 85234

  • Prisma Health

    Greenville, South Carolina, 29605

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California San Diego

    La Jolla, California, 92037

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Miami

    Miami, Florida, 33136

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Tennessee Oncology, PLLC - Elliston Place Plaza DDU

    Nashville, Tennessee, 37203

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Providence St. John's Health Center

    Santa Monica, California, 90404

  • University of Arizona

    Tucson, Arizona, 85719

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

France4 sites

  • INS Bergonie

    Bordeaux, 33000

  • HOP Timone

    Marseille, 13385

  • CTR Eugène Marquis

    Rennes, 35042

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain3 sites

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Clínica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Australia2 sites

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 5062

  • Peninsula Haematology & Oncology

    Frankston, Victoria, 3199

Other trials in Australia

Austria2 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • Salzburg Cancer Research Institute

    Salzburg, 5020

Other trials in Austria

Belgium2 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Germany2 sites

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy1 site

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

Other trials in Italy

Switzerland1 site

  • University Hospital Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Solid Tumors
Being tested
BI 1831169, anti-PD-1 antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1831169Drug

    BI 1831169

  • anti-PD-1 antibodyDrug

    anti-PD-1 antibody

Study groups in NCT05155332
Study groupRoleWhat they receive
Part 1 (Monotherapy): Arm AExperimentalNot described
Receives: Drug: BI 1831169
Part 1 (Monotherapy): Arm BExperimentalNot described
Receives: Drug: BI 1831169
Part 1 (Monotherapy): Arm CExperimentalNot described
Receives: Drug: BI 1831169
Part 2 (Combination therapy): Arm DExperimentalNot described
Receives: Drug: BI 1831169; Drug: anti-PD-1 antibody
Part 2 (Combination therapy): Arm EExperimentalNot described
Receives: Drug: BI 1831169; Drug: anti-PD-1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Part 1 (Monotherapy).

    Measured: up to 21 days

  2. 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.

    Measured: up to 49 months

  3. 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).

    Measured: up to 21 days

  4. 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).

    Measured: up to 49 months

Secondary outcomes (10)

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

    Measured: up to 49 months

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

    Measured: up to 49 months

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

    Measured: up to 49 months

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

    Measured: up to 49 months

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

    Measured: up to 49 months

  6. Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

    Measured: up to 49 months

  7. Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period

    Measured: up to 49 months

  8. 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.

    Measured: up to 49 months

  9. 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.

    Measured: up to 49 months

  10. 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.

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start28 Mar 2022
  3. Primary completion13 Dec 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Why it stopped: Sponsor decision - temporary enrolment hold as a precautionary measure following a safety event.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155332
Sponsor's protocol ID
1456-0001
Other IDs
2020-003902-30
Status last verified
Oct 2026
First submitted
10 Dec 2021
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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

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.

    PubMed 35699077

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1831169 and anti-PD-1 antibody in people with Solid Tumors, run by Boehringer Ingelheim at 33 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, France, Spain, Australia, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period (time frame: up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155332, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in