Clinical Trial

A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors

Active, Not Recruiting Phase 1
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Record status
This record was last updated January 8, 2026 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase 1, open-label, multicenter clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of FL115 administered as monotherapy in subjects with unresectable locally advanced or metastatic solid tumors. The study consists of a dose escalation phase followed by a dose expansion phase to further characterize the safety profile and clinical activity at the recommended dose level.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-12.
Status change: Recruiting → Active, Not Recruiting 2026-01-06
Trial Details
NCT Number NCT07131189
Lead Sponsor Suzhou Forlong Biotechnology Co., Ltd
Conditions Locally Advanced/Metastatic Solid Tumors
Enrollment 30 participants
Start Date 2024-05-30
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-08