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A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD 1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies

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Trial Profile

A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD 1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Oct 2021

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At a glance

  • Drugs Cemiplimab (Primary) ; Carboplatin; Cyclophosphamides; Docetaxel; Granulocyte macrophage colony stimulating factor; Paclitaxel; Pemetrexed
  • Indications Adenocarcinoma; Carcinoma; Cervical cancer; Head and neck cancer; Liver cancer; Neuroendocrine carcinoma; Non-small cell lung cancer; Skin cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals; Sanofi

    • Most Recent Events

    • 01 Sep 2021 Primary endpoint has not been met (HNSCC expansion cohort: safety, tolerability, and dose-limiting toxicities of cemiplimab in combination with RT, cyclophosphamide, and GM-CSF) , according to Results published in the Oncologist
    • 01 Sep 2021 Results (n=15) from expansion cohort3 of a dose-escalation phase of this trial in Head and neck cancers patients with advanced malignancies published in the Oncologist
    • 25 Mar 2021 Results assessing fixed dose of cemiplimab in patients with advanced malignancies using population pharmacokinetics (PopPK) modeling and simulations, published in the Advances in Therapy.
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