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New cancer drug combo targets Hard-to-Treat tumors

NCT ID NCT05155332

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This early-phase study tests a new drug, BI 1831169, given alone or with an immunotherapy (anti-PD-1 antibody) in adults with advanced solid tumors that cannot be removed by surgery or have spread. The main goals are to find the highest safe dose and see if the treatment shrinks tumors. Participants receive the drug every 3 weeks for up to 3 months (alone) or up to 1 year (with immunotherapy). The trial is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1831169 (injected into tumor or infused into vein) and an anti-PD-1 antibody (checkpoint inhibitor, infused into vein)
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that are hard to treat.
What could go wrong
This is a very early (Phase 1) and small study, so the treatment may not work or may cause side effects. The trial is currently suspended, which adds uncertainty.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

  • Banner MD Anderson Cancer Center-Gilbert-55251

    Gilbert, Arizona, 85234, United States

  • CTR Eugène Marquis

    Rennes, 35042, France

  • Clínica Universidad de Navarra

    Pamplona, 31008, Spain

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • HOP Timone

    Marseille, 13385, France

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907, Spain

  • INS Bergonie

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Istituto Di Candiolo

    Candiolo (TO), 10060, Italy

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • Medical University of Innsbruck

    Innsbruck, 6020, Austria

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Peninsula Haematology & Oncology

    Frankston, Victoria, 3199, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Providence St. John's Health Center

    Santa Monica, California, 90404, United States

  • Salzburg Cancer Research Institute

    Salzburg, 5020, Austria

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University Hospital Geneva

    Geneva, 1205, Switzerland

  • University of Arizona

    Tucson, Arizona, 85719, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

More trials for these conditions

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