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Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

Trial Profile

Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

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

Latest Information Update: 27 Feb 2024

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At a glance

  • Drugs Nivolumab (Primary) ; ONO 4578 (Primary)
  • Indications Colorectal cancer; Gastric cancer; Oesophageal cancer; Solid tumours
  • Focus Adverse reactions; Biomarker; First in man
  • Sponsors Ono Pharmaceutical
  • Most Recent Events

    • 20 Jan 2024 Results (n=51) evaluating safety profile in patients with mCRC presented at the 2024 Gastrointestinal Cancers Symposium
    • 24 Oct 2023 Results (n=66) assessing the safety, preliminary efficacy, and biomarkers for ONO-4578 plus nivolumab for Part C in gastric or gastroesophageal cancer, presented at the 48th European Society for Medical Oncology Congress.
    • 01 Jan 2023 Results(n=31) assessing safety, efficacy, and pharmacokinetics/pharmacodynamics of ONO-4578 alone and with nivolumab in solid tumors published in the Cancer Science
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