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A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors

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Trial Profile

A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2024

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At a glance

  • Drugs Olaparib (Primary) ; SIM 0508 (Primary)
  • Indications Advanced breast cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Jiangsu Simcere Pharmaceutical

    • Most Recent Events

    • 13 Nov 2024 Status changed from planning to not yet recruiting.
    • 19 Sep 2024 New trial record
    • 29 Aug 2024 According to a Simcere media release, company announced that the investigational new drug (IND) application of SIM0508 has been approved by the Food and Drug Administration (FDA). The has been cleared to carry out clinical trials in patients with locally advanced/metastatic solid tumor in both China and the United States.

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