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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: 24 Sep 2026

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At a glance

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

Most Recent Events

  • 28 Jul 2026 Planned number of patients changed from 414 to 738.
  • 19 Jun 2026 According to Simcere Zaiming media release, data from this trial will be presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO) held from May 29 to June 2, 2026.
  • 04 Jun 2026 According to Simcere Zaiming media release, company has announced the replay availability for its virtual key opinion leader (KOL) event on SIM0505, held following the companys ASCO 2026 poster presentation of first reported clinical efficacy data from its Phase 1 dose escalation study.

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