RecruitingPhase 1NCT07607678

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

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)


Sponsor

Boehringer Ingelheim

Enrollment

60 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BI 3819026 and a drug called Ezabenlimab (BI 754091) for people with advanced solid cancer and metastatic solid cancer. The study is currently recruiting participants at 9 locations.

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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Interventions

DRUGBI 3819026

BI 3819026

DRUGEzabenlimab (BI 754091)

Ezabenlimab (BI 754091)


Locations(9)

Yale Cancer Center

New Haven, Connecticut, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

New York University Langone Medical Center

New York, New York, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07607678


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