A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 765179: BI 765179
Ezabenlimab: Ezabenlimab
Pembrolizumab: Pembrolizumab
Study summary
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer.
In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein.
BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time.
Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.
Eligibility
Primary outcome measure(s)
- Phase 1a: Maximum Tolerated Dose (MTD) — Up to Day 21 (end of Cycle 1)
MTD is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to Common terminology criteria for adverse events (CTCAE) version 5.0, during the MTD evaluation period. - Phase 1a: Occurrence of Dose Limiting Toxicities (DLTs) in the MTD evaluation period — Up to Day 21 (end of Cycle 1)
- Phase 1b: Objective response (OR) — Up to 2 years.
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response evaluation criteria in solid tumors (RECIST) version (v) 1.1 by Investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona | Tucson | Arizona | |
| Beverly Hills Cancer Center | Beverly Hills | California | |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Avera Cancer Institute | Sioux Falls | South Dakota | |
| NEXT Oncology-San Antonio-65273 | San Antonio | Texas | |
| Border Cancer Hospital | Albury | New South Wales | |
| Kinghorn Cancer Centre | Darlinghurst | New South Wales | |
| Townsville Hospital | Douglas | Queensland | |
| Austin Hospital | Heidelberg | Victoria | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | |
| AZ Groeninge | Kortrijk | Belgium | |
| ICESP - Instituto do Cancer do Estado de Sao Paulo | São Paulo | Brazil | |
| Hospital Sírio Libanês-São Paulo-68088 | São Paulo | Brazil | |
| Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência | São Paulo | Brazil | |
| The First Affiliated Hospital Of Bengbu Medical College | Bengbu | China | |
| Hunan Province Tumor Hospital | Changsha | China | |
| Fujian Cancer Hospital | Fuzhou | China | |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | China | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China | |
| Masaryk Memorial Cancer Institute | Brno | Czechia | |
| HOP Saint-André | Bordeaux | France | |
| CTR Georges-François Leclerc | Dijon | France | |
| INS Cancérologie Ouest Saint-Herblain | Saint-Herblain | France | |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany | |
| Martin-Luther-Universität Halle-Wittenberg | Halle | Germany | |
| Klinikum Stuttgart | Stuttgart | Germany | |
| Shaare-Zedek Medical Center, Oncology Institute | Jerusalem | Israel | |
| Sourasky Medical Center | Tel Aviv | Israel | |
| Istituto Nazionale IRCCS Tumori Fondazione Pascale | Naples | Italy | |
| Aichi Cancer Center Hospital | Aichi, Nagoya | Japan | |
| National Cancer Center Hospital East | Chiba, Kashiwa | Japan | |
| Kanagawa Cancer Center | Kanagawa, Yokohama | Japan | |
| Kansai Medical University Hospital | Osaka, Hirakata | Japan | |
| Osaka International Cancer Institute | Osaka, Osaka | Japan | |
| Centro Oncologico Internacional | Mexico City | Mexico | |
| Instituto Nacional de Cancerologia | México | Mexico | |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | Mexico | |
| Fundación Santos y de la Garza Evia, I.B.P | Monterrey | Mexico | |
| VU University Medical Center | Amsterdam | Netherlands |
+ 8 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Boehringer Ingelheim trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04958239 on ClinicalTrials.gov ↗ ← All trials in Italy