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Recruiting Phase 1 Interventional

A Study of BI 3810944 in Patients With Advanced Cancer

ClinicalTrials.gov ID: NCT07224425

Public ClinicalTrials.gov record NCT07224425. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 11:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. 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. The treatment duration is planned for 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.

Study identification

NCT ID
NCT07224425
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
69 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 24, 2026 (Actual)
Primary completion
Oct 5, 2029 (Estimated)
Completion
Oct 5, 2029 (Estimated)
Last update posted
Oct 30, 2026

2026 – 2029

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
University of Louisville Louisville Kentucky 40202 Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza DDU Nashville Tennessee 37203 Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas 77030 Not yet recruiting
University of Virginia Health System Charlottesville Virginia 22908 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07224425, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 30, 2026 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07224425 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →