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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

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: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Nov 2019

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At a glance

  • Drugs BI 754091 (Primary) ; BI 765063 (Primary)
  • Indications Advanced breast cancer; Carcinoma; Colorectal cancer; Gastric cancer; Head and neck 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 Nov 2019 According to an OSE Immunotherapeutics media release, this study was presented at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
    • 06 Nov 2019 Trial design released at 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 17 Jun 2019 According to the Boehringer Ingelheim and OSE Immunotherapeutics SA media release, dosing of the first patient has been done in this Phase 1 trial and this triggers milestone payments of a total of 15 million Euro to OSE Immunotherapeutics from Boehringer Ingelheim.
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