Trials / Active Not Recruiting
Active Not RecruitingNCT06091930
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 97 (estimated)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Gastrointestinal Cancer
- Lung Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Head and Neck Cancer
- Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 765049 | BI 765049 |
| DRUG | Ezabenlimab | Ezabenlimab |
Timeline
- Start date
- 2024-02-16
- Primary completion
- 2028-06-09
- Completion
- 2028-09-10
- First posted
- 2023-10-23
- Last updated
- 2026-04-14
Locations
6 sites across 3 countries: China, Japan, South Korea
Source: ClinicalTrials.gov record NCT06091930. Inclusion in this directory is not an endorsement.