NCT06130722

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

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: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Suzhou Forlong Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a First-in-Human, Phase I, open-label, multicenter, dose-escalation clinical study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 when administered IV to adult patients with locally advanced/metastatic solid tumors who have progressed on, cannot tolerate, or do not have a standard-of-care therapy. If a patient is intolerant to standard-of-care therapy, the reason that the treatment could not be tolerated will be documented in the electronic case report form (eCRF). Patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-hour inpatient monitoring for future injections (i.e. 2nd, 3rd and 4th dosing) based on the investigator discretion. Seven dosing cohorts are planned, with doses of 3, 10, 30, 60, 120, 180 and 240 µg/kg. For ethical reasons, the first 2 dose cohorts (3 and 10 µg/kg) are planned to enroll 1 patient per cohort because these 2 doses are considered suboptimal treatment for late-stage cancer patients. The first 2 dose level cohorts will each enroll 1 patient using an accelerated titration dose escalation design. If no DLT is observed by the end of the first cycle (28 days) of treatment, the dose will be escalated to the next dose cohort. However, if 1 treatment-related National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading ≥ Grade 2 toxicity occurs in the safety evaluation window, the study will be converted to a 3 + 3 design. After the initial 2 cohorts are completed, the study will use modified Fibonacci 3 + 3 dose-escalation design.

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: 2023-12-30
• Primary completion: 2025-02-15
• Completion: 2025-09-19
• First posted: 2023-11-14
• Last updated: 2026-01-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study