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RecruitingLast updated: 26 February 2026

BI 1456-0001: This study is open to adults with different types of advanced solid cancers that are accessible for injection and/or biopsy to investigate a medicine called BI 1831169Phase 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

BI 1456-0001

Clinical summary

Summary

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, or immunotherapy).

Another purpose of the study is to check whether the treatment can fight cancer. In this study, BI 1831169 is being given to people for the first time.

The 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 tumour, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into the vein. Participants get the medicines about every 3 weeks.

Participants visit the 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 tumours. The doctors also take note of any health problems that could have been caused by the study treatment.

 

Conditions

This trial is treating people with diagnosis of an advanced, metastatic or relapsed/refractory solid tumour for whom standard treatment hasn't been successful or is not available

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Boehringer Ingelheim

Scientific 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

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