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)

Launched by BOEHRINGER INGELHEIM · Dec 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BI 1831169, which is being tested alone and in combination with another treatment known as a checkpoint inhibitor (anti-PD-1 antibody) in adults with advanced solid tumors. The goal is to find the highest dose of BI 1831169 that patients can safely tolerate and to see if it can help fight cancer. Participants must have a confirmed diagnosis of advanced cancer that has not responded to previous treatments and should have at least one tumor that can be injected or biopsied.

The study has two parts: in the first part, participants will receive BI 1831169 alone for up to three months. In the second part, they will receive BI 1831169 along with the checkpoint inhibitor for up to one year. Treatments are given every three weeks, either through an injection into the tumor, an infusion into the vein, or both. Participants will need to visit the study site regularly for health check-ups and monitoring of their tumors, which may include some overnight stays. This trial is currently recruiting participants aged 65 and older. If you or a loved one is considering joining, it's important to discuss eligibility and any concerns with your healthcare provider.

Gender

ALL

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.