Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT05155332
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05155332
Study Brief:
Protocol Section:
NCT05155332