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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: 26 Nov 2025

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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

  • 05 Nov 2025 According to Jiangsu Simcere Pharmaceutical media release,company expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China.
  • 16 Oct 2025 According to Jiangsu Simcere Pharmaceutical media release, first patient in the U.S. has been dosed. And, clinical data is anticipated in the first half of 2026.
  • 16 Oct 2025 According to NextCure media release, Simcere Zaiming and NextCure has now expanded the ongoing Phase 1 dose escalation study, which was initiated in China, by enrolling patients in the US into a mid-tier dose level.

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