drugset
drugset / Trial / NCT06130722

First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study

NCT06130722 ↗

Phase 1 Completed 18 enrolled Suzhou Forlong Biotechnology Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, including immune check-point inhibitors administered in single-agent or combination use.

Timeline

Start
2023-12-30
Primary completion
2025-02-15
Completion
2025-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject FL115 Protein / enzyme biologic 3 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 10 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 30 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 60 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 120 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 180 ug/kg Intravenous
Subject FL115 Protein / enzyme biologic 240 ug/kg Intravenous

Indications

RET fusion positive cancer