A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface
Public ClinicalTrials.gov record NCT04752215. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A First-in-human Phase I, Non-randomized, Open-label, Multi-center Dose-escalation Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Parenteral Administration(s) in Patients With Malignant Solid Tumors Expressing B7-H6.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer. The study tests 2 medicines called BI 765049 and ezabenlimab (BI 754091). Both medicines may help the immune system fight cancer. The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate. In this study, BI 765049 is given to people for the first time. Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with ezabenlimab as infusion into a vein 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. The doctors also regularly monitor the size of the tumor.
Study identification
- NCT ID
- NCT04752215
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 67 participants
Conditions and interventions
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 17, 2021
- Primary completion
- Nov 18, 2024
- Completion
- Dec 16, 2024
- Last update posted
- Feb 1, 2026
2021 – 2024
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | — |
| University of California Irvine | Orange | California | 92868 | — |
| HealthONE | Denver | Colorado | 80218 | — |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | — |
| Florida Cancer Specialists-Sarasota-61670 | Sarasota | Florida | 34232 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Norton Healthcare - Norton Cancer Institute - Louisville | Louisville | Kentucky | 40202 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Tennessee Oncology, PLLC-Nashville-52568 | Nashville | Tennessee | 37203 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04752215, 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 Feb 1, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04752215 live on ClinicalTrials.gov.