CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
FL115drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06130722
NCT06130722Phase 1Completed
CompareCT.gov

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

Suzhou Forlong Biotechnology Co., Ltd·interventional·Posted Nov 14, 2023·Updated Jan 7, 2026

In Brief

A Phase 1 clinical trial evaluating FL115 for Locally Advanced/Metastatic Solid Tumors. Completed, enrolled 18 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced/Metastatic Solid Tumors
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedNov 14, 2023
Enrollment StartDec 30, 2023
Primary CompletionFeb 15, 2025
Study CompletionSep 19, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.6 years ago

Interventions

FL115drug

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).