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RECRUITING
NCT05471856
PHASE1

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.

Official title: Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2023-02-24

Completion Date

2028-09-13

Last Updated

2025-12-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

BI 1703880

BI 1703880

DRUG

Ezabenlimab

Ezabenlimab

Locations (13)

Valkyrie Clinical Trials

Los Angeles, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Saitama Medical University International Medical Center

Saitama, Hidaka, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Hospital Universitari Vall D Hebron

Barcelona, Spain

CIO Clara Campal

Madrid, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Hospital Clinico Universitario De Valencia

Valencia, Spain

The Royal Marsden Hospital, Chelsea

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

The Royal Marsden Hospital, Sutton

Sutton, United Kingdom