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An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

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Trial Profile

An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

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

Latest Information Update: 18 Sep 2023

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At a glance

  • Drugs BI 765063 (Primary) ; Ezabenlimab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Carcinoma; Colon cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Liver cancer; Lung cancer; Malignant melanoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Renal cell carcinoma; Small cell lung cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Sponsors OSE Immunotherapeutics

    • Most Recent Events

    • 11 Sep 2023 Planned End Date changed from 31 Dec 2022 to 30 Dec 2025.
    • 11 Sep 2023 Status changed from recruiting to active, no longer recruiting.
    • 19 Apr 2023 Results assessing (n=68) the predictive response biomarkers of BI765063 stand-alone and in combination with ezabenlimab in patients with advanced solid tumors, presented at the 114th Annual Meeting of the American Association for Cancer Research.

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