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Testing a new cancer treatment with BI 1831169 and an anti-PD-1 antibody

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

Phase 1 Interventional Boehringer Ingelheim · NCT05155332

This study is testing a new cancer treatment called BI 1831169, both by itself and with another medication, to see how well it works for adults with advanced solid tumors who have few other options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations40 sites (Gilbert, Arizona and 39 other locations)
Trial IDNCT05155332 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed for adults with advanced solid tumors who have limited treatment options. It aims to determine the highest tolerable dose of a new medication called BI 1831169, both alone and in combination with an anti-PD-1 antibody. The study consists of two parts: the first part involves administering BI 1831169 alone for up to three months, while the second part combines it with the antibody for up to one year. Participants will receive the treatment through injections into the tumor or infusions into the vein.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced, unresectable, or metastatic solid tumors who have failed conventional treatments.

Not a fit: Patients with solid tumors that are resectable or those who have not yet exhausted available treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancer who have exhausted existing treatments.

How similar studies have performed: Other studies have shown promise with similar combination therapies, but this specific approach with BI 1831169 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.