NCT07131189

A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of FL115 Monotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors, Including Dose Escalation and Cohort Expansion

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Suzhou Forlong Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	FL115	FL115 is a novel long-acting IL-15 agonist designed as a fusion protein with a mutated IL-15 structure (IL-15\[N72D\]/IL-15Rα-sFc).

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-06-01
• Completion: 2026-08-10
• First posted: 2025-08-20
• Last updated: 2026-01-08

Locations

3 sites across 1 country: China