Scholarlink

Background <p>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.</p> Methods <p>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.</p> Results <p>Anti-tumour responses showed either stable disease (SD) or disease progression (PD). GX-I7 demonstrated dose-dependent increases in the maximum serum concentration (C<sub>max</sub>) and area under the curve up to the last measurable concentration (AUC<sub>last</sub>). In addition, a dose-dependent increase in circulating CD8<sup>+</sup>/CD4<sup>+</sup> T cells was observed. In five patients who consented for biopsy, a statistically significant increase in tumour-infiltrating lymphocytes (TILs) followed GX-I7 treatment.</p> Discussion <p>Findings suggest GX-I7 is a safe T cell-amplifying agent with peripheral immune activation. Ongoing studies are exploring its ability to enhance immune responses in peripheral immune cells and tumour cells when combined with other anti-cancer agents.</p> Clinical Trial registration <p>NCT03478995</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年6月9日

查看全文
  • Gun Min Kim,
  • Sojeong Kim,
  • Myung Ah Lee,
  • Mi-Sun Byun,
  • Donghoon Choi,
  • Se Hwan Yang,
  • JungWon Woo,
  • Young Chul Sung,
  • Eui-Cheol Shin,
  • Su-Hyung Park,
  • Tae Won Kim,
  • Joohyuk Sohn

摘要

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 disease (SD) or disease progression (PD). GX-I7 demonstrated dose-dependent increases in the maximum serum concentration (Cmax) and area under the curve up to the last measurable concentration (AUClast). In addition, a dose-dependent increase in circulating CD8+/CD4+ T cells was observed. In five patients who consented for biopsy, a statistically significant increase in tumour-infiltrating lymphocytes (TILs) followed GX-I7 treatment.

Discussion

Findings suggest GX-I7 is a safe T cell-amplifying agent with peripheral immune activation. Ongoing studies are exploring its ability to enhance immune responses in peripheral immune cells and tumour cells when combined with other anti-cancer agents.

Clinical Trial registration

NCT03478995