RecruitingPhase 1NCT06091930

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6

Phase I, Non-randomised, Open-label, Multi-centre Dose Escalation and Expansion Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Repeated Intravenous Infusion in Asian Patients With Malignant Solid Tumours Expressing B7-H6


Sponsor

Boehringer Ingelheim

Enrollment

97 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a study in adults from Asia with different types of advanced cancer (solid tumours). People can join the study if they have cancer of the stomach, large bowel and rectum, pancreas, liver, head and neck or non-small cell lung cancer. This is a study for people for whom previous treatment was not successful or no treatment exists. People can participate if their tumour has the B7-H6 marker. The purpose of this study is to find the highest dose of BI 765049 that people with advanced cancer can tolerate when taken (alone and) together with ezabenlimab. Another purpose is to check whether BI 765049 taken (alone and) together with ezabenlimab can make tumours shrink. Both medicines may help the immune system fight cancer. Participants can stay in the study up to 3 years, as long as they can tolerate it and can benefit from it. During this time, they visit the study site about every 3 weeks. At the study site they get BI 765049 alone or in combination with ezabenlimab as an infusion into a vein. BI 765049 is given in 3-week cycles, ezabenlimab is given once every 3 weeks. The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called BI 765049, alone and in combination with another immunotherapy drug called ezabenlimab, in Asian patients with advanced cancers that have tested positive for a protein called B7-H6 on the tumor. The study aims to find the right dose and assess whether the treatment is safe and effective. **You may be eligible if...** - You are 18 or older - You have advanced, inoperable, or spreading cancer of the stomach, colon/rectum, pancreas, liver, head and neck, or lung - Your cancer has progressed despite standard treatments, or you cannot tolerate standard treatments - Your tumor tests positive for the B7-H6 protein (a tissue test is required) - You are in good enough health to carry out light activities (ECOG 0-1) - You have at least one measurable tumor outside the brain **You may NOT be eligible if...** - You had major surgery within the past 28 days - You have had a previous different cancer (with some exceptions) - You have active autoimmune disease or serious other medical conditions 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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Interventions

DRUGBI 765049

BI 765049

DRUGEzabenlimab

Ezabenlimab


Locations(7)

Shanghai East Hospital

Shanghai, China

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Kansai Medical University Hospital

Osaka, Hirakata, Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06091930


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