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First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FL115 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors

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Trial Profile

First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FL115 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Jan 2026

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At a glance

  • Drugs FL 115 (Primary)
  • Indications Cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Suzhou Forlong Biotechnology

Most Recent Events

  • 07 Jan 2026 Status changed from recruiting to completed.
  • 30 Oct 2025 ccording to the Forlong Biotechology media release, company announced that a late-breaking abstract featuring interim safety and efficacy data from this study has been selected for poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025) being held November 5-9, 2025, in National Harbour, Maryland.
  • 26 Jun 2025 Planned End Date changed from 30 Sep 2025 to 30 Sep 2026.

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