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An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)

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Trial Profile

An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2025

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At a glance

  • Drugs BI 765063 (Primary) ; BI 836880 (Primary) ; Cetuximab (Primary) ; Ezabenlimab (Primary) ; Capecitabine; Docetaxel; Fluorouracil; Methotrexate; Paclitaxel
  • Indications Carcinoma; Head and neck cancer; Liver cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 06 May 2025 Patients will receive cetuximab in addition to BI 765063 and ezabenlimab. Ezabenlimab treatment and any other assigned treatment are given no longer than 2 years. Previously, BI 765063 and ezabenlimab were also given alone, or in combination with chemotherapy, or with BI 836880.
  • 23 Apr 2025 According to a OSE Immunotherapeutics media release, company will present data from this study at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 1-5, 2025, in Chicago, Illinois.
  • 15 Apr 2025 Planned End Date changed from 30 Apr 2026 to 31 Jul 2026.

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