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Active, not recruiting Phase 1 Interventional

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

ClinicalTrials.gov ID: NCT05327946

Public ClinicalTrials.gov record NCT05327946. 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 Sep 5, 2026, 8:53 AM EDT

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

Official title

An Open-label, Phase I Dose Escalation Followed by Dose Expansion Trial in Patients With Advanced Solid Tumours to Investigate Safety, Pharmacokinetics, and Efficacy and to Select the Dose for Further Development of BI 770371 in Combination With Ezabenlimab

Brief summary

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

This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study. The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab. BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time. Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks. It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.

Study identification

NCT ID
NCT05327946
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
42 participants

Conditions and interventions

Conditions

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
May 16, 2022
Primary completion
Jul 15, 2024
Completion
Mar 30, 2027
Last update posted
Aug 31, 2026

2022 – 2027

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Florida Cancer Specialists-Sarasota-61670 Sarasota Florida 34232
John Theurer Cancer Center Hackensack New Jersey 07601

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 NCT05327946, 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 Aug 31, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05327946 live on ClinicalTrials.gov.

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