RecruitingPhase 1NCT07224425

A Study of BI 3810944 in Patients With Advanced Cancer

A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma

Sponsor

Boehringer Ingelheim

Enrollment

69 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Melanoma Solid Tumours

Summary

This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer. Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. The doctors also regularly check the size of the tumour with imaging methods.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called BI 3810944 in adults with advanced solid tumor cancers that have spread or cannot be surgically removed. It is an early-phase study primarily looking at safety and the right dose, with different treatment arms testing the drug in specific cancer types. **You may be eligible if...** - You are an adult with a confirmed solid tumor cancer (any type in early parts of the study, specific types in later parts) - You have already tried available standard treatments, they didn't work, or you are not eligible for them - You have good general health and are fully or mostly active in daily life (ECOG 0 or 1) - You have at least one measurable tumor outside the brain that can be tracked on scans - For the expansion phase (Part B): you have received no more than 3 prior lines of treatment, and your tumor's BRAF status is known **You may NOT be eligible if...** - You have untreated cancer spread to the brain - Your overall health or organ function does not meet the study's standards - You have had a recent serious medical event or are on certain medications that may interact Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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