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ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors.

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Trial Profile

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Oct 2020

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At a glance

  • Drugs Nivolumab (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Ono Pharmaceutical

    • Most Recent Events

    • 01 Nov 2018 Results of ONO-4538-01, ONO-4538-02, ONO-4538-04, ONO-4538-05, ONO-4538-06, and ON-4538-08 evaluating risk factors and the clinical course of Thyroid Dysfunction induced by nivolumab, published in the Cancer Science.
    • 19 Oct 2018 Results of a pooled population pharmacokinetics and exposure-safety analysis from 9 studies, published in the Journal of Clinical Pharmacology.
    • 08 Dec 2016 Results published in the Investigational New Drugs
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