A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

ClinicalTrials.gov ID: NCT07607678

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Official title

A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)

Brief summary

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

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer. Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study. Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

Study identification

NCT ID: NCT07607678
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

BI 3819026 Drug
Ezabenlimab (BI 754091) Drug

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: May 1, 2026 (Actual)
Primary completion: Jun 5, 2028 (Estimated)
Completion: Oct 15, 2030 (Estimated)
Last update posted: Nov 10, 2026

2026 – 2030

United States locations

U.S. sites: 4
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
Yale Cancer Center	New Haven	Connecticut	06511	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
New York University Langone Medical Center	New York	New York	10016	Not yet recruiting
SCRI Oncology Partners	Nashville	Tennessee	37203	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 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07607678, 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 Nov 10, 2026 · Synced Nov 12, 2026