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 (NCT04958239)
An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- 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,
- Universitair Ziekenhuis Antwerpen — Edegem,
- AZ Groeninge — Kortrijk,
- ICESP - Instituto do Cancer do Estado de Sao Paulo — São Paulo,
- Hospital Sírio Libanês-São Paulo-68088 — São Paulo,
- Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência — São Paulo,
- The First Affiliated Hospital Of Bengbu Medical College — Bengbu,
- Hunan Province Tumor Hospital — Changsha,
- Fujian Cancer Hospital — Fuzhou,
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou,
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan,
- Masaryk Memorial Cancer Institute — Brno,
- HOP Saint-André — Bordeaux,
- CTR Georges-François Leclerc — Dijon,
- INS Cancérologie Ouest Saint-Herblain — Saint-Herblain,
- Universitätsklinikum Freiburg — Freiburg im Breisgau,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.