NCT05155332

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)

Recruiting now Phase 1 Last updated 14 April 2026

What this trial tests

Phase 1 trial testing BI 1831169 in Solid Tumors in 190 participants. Currently enrolling.

Timeline

28 March 2022

Primary endpoint
13 December 2027

31 October 2028

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	190
Start date	28 March 2022
Primary completion	13 December 2027
Estimated completion	31 October 2028
Sites	40 locations across France, Italy, Belgium, Austria, Germany, Canada, Switzerland, Australia

Drugs / interventions tested

• BI 1831169 — full drug profile →
• anti-PD-1 antibody — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors.
   Porosnicu M, Quinson AM, Crossley K, Luecke S, et al · · 2022 · cited 22× · PMID 35699077 · DOI 10.2217/fon-2022-0439
2. Quad-shot-immunotherapy: quad-shot radiotherapy with pembrolizumab for advanced/recurrent head and neck cancer.
   Hughes RT, Gebeyehu RR, Kalada JM, Lycan TW, et al · · 2023 · cited 6× · PMID 37199326 · DOI 10.2217/fon-2022-1146
3. Characterization of the Anti-Viral and Vaccine-Specific CD8⁺ T Cell Composition upon Treatment with the Cancer Vaccine VSV-GP.
   Hofer T, Pipperger L, Danklmaier S, Das K, et al · · 2024 · cited 4× · PMID 39203993 · DOI 10.3390/vaccines12080867
4. Murine colon cancer derived cells exhibit heterogeneous resistance profiles against an oncolytic virus.
   Larrieux A, Sanjuán R. · · 2024 · cited 1× · PMID 39516525 · DOI 10.1038/s41598-024-78313-6
5. The oncolytic vesicular stomatitis virus VSV-GP shows profound oncolytic activity in NUT-carcinoma cell lines.
   Buchenau RC, Schiller AM, Beil J, Berchtold S, et al · · 2026 · PMID 41766922 · DOI 10.1016/j.omton.2026.201140
6. Newly identified oncolytic VSV-GP-specific CD8<sup>+</sup> T cell epitopes for monitoring of anti-viral immune responses in the BALB/c mouse model.
   Danklmaier S, Vijver SV, Pipperger L, Floriani G, et al · · 2025 · PMID 41282468 · DOI 10.1016/j.omton.2025.201072