GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8⁺/CD4⁺ T cells and TILs in patients with locally advanced or metastatic solid tumours.

ABSTRACT:

Background

GX-I7 (rhIL-7-hyFc, efineptakin alfa) is a hybrid Fc-fused long-acting interleukin-7 (IL-7) with the aim of correcting T-cell deficiency, thereby strengthening the immune response to fight against cancer. This Phase 1b, dose-escalation study was designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GX-I7 in patients with locally advanced or metastatic solid tumours.

Methods

This study, conducted in patients with advanced solid tumours at three hospitals in Korea, involved intramuscular GX-I7 administration across eight dose levels (60-1700 µg/kg) in 3- and 6-week cohorts. A dose-expansion phase at 720 and 1200 µg/kg further assessed GX-I7's safety and efficacy.

Results

Anti-tumour responses showed either stable dis

SUBMITTER: Kim GM 

PROVIDER: S-EPMC12356974 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature