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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs BI 765179 (Primary) ; Ezabenlimab (Primary) ; Pembrolizumab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Bladder cancer; Brain metastases; Carcinoma; Cervical cancer; Colorectal cancer; Gastric cancer; Head and neck cancer; Liver cancer; Malignant-mesothelioma; Mesothelioma; Mouth neoplasm; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Skin cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 22 May 2025 According to a Boehringer Ingelheim media release, company will present the latest data from this trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • 30 Apr 2025 Trial design presented at the 116th Annual Meeting of the American Association for Cancer Research
  • 03 Apr 2025 Planned End Date changed from 17 Nov 2028 to 19 Nov 2028.

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