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A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors

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Trial Profile

A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 16 Apr 2026

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At a glance

  • Drugs SIM-0505 (Primary)
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Renal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Jiangsu Simcere Pharmaceutical; NextCure

Most Recent Events

  • 07 Apr 2026 According to NextCure media release, data form this phase I trial will be presented at the upcoming 2026 American Society of Clinical Oncology conference.
  • 05 Mar 2026 According to NextCure media release, compoany plan to double the number trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.
  • 05 Mar 2026 According to NextCure media release, data expected in Q2 2026. Initiation of dose optimization in ovarian cancer anticipated in Q2 2026

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