A phase Ib study of photoimmunotherapy with ASP-1929 in combination with nivolumab for advanced gastric cancer (GE-PIT, EPOC1901).

IF 6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastric Cancer Pub Date : 2025-05-15 DOI:10.1007/s10120-025-01623-9

Tomohiro Kadota, Rika Fujii, Shohei Koyama, Daisuke Kotani, Yusuke Yoda, Miki Fukutani, Mitsuko Suzuki, Masashi Wakabayashi, Takashi Ikeno, Hironori Sunakawa, Yoshiaki Nakamura, Akihito Kawazoe, Takuma Irie, Nozomu Fuse, Akihiro Sato, Tomonori Yano, Kohei Shitara

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引用次数: 0

Abstract

Background: Photoimmunotherapy with ASP-1929 (cetuximab conjugated to IRDye 700DX) and 690-nm red light has shown promising results, with a 43% objective response rate (ORR) in a phase IIa trial for recurrent head and neck squamous cell carcinoma. This study aimed to evaluate the safety and efficacy of combining photoimmunotherapy with nivolumab for advanced gastric cancer.

Methods: This phase Ib open-label, single-center trial investigated the combination of photoimmunotherapy with ASP-1929 and nivolumab in patients with unresectable EGFR-positive gastric adenocarcinoma after standard chemotherapy. The dose-escalation part aimed to determine the recommended dose of laser illumination energy under endoscopy, and the expansion part assessed the safety and efficacy at the determined dose. The primary endpoint was dose-limiting toxicity (DLT), and treatment response and adverse events were evaluated.

Results: Between October 2019 and April 2022, 21 patients were enrolled. All patients had previously received at least two lines of chemotherapy, with six being refractory to anti-PD-1 therapy. No DLT was observed, and the recommended dose was 100 J/cm². Two patients achieved a partial response, and ORR was 9.5%.

Conclusion: This study demonstrated that combining endoscopic photoimmunotherapy with nivolumab is safe and feasible for advanced gastric cancer.

Trial registry: The trial is registered in the Japanese Registry of Clinical Trials (identifier: jRCT2080224884, https://jrct.niph.go.jp/en-latest-detail/jRCT2080224884 ).

查看原文本刊更多论文

ASP-1929联合纳武单抗治疗晚期胃癌的Ib期研究（GE-PIT, EPOC1901）。

背景：ASP-1929（西妥昔单抗与IRDye 700DX结合）和690 nm红光的光免疫治疗显示出令人希望的结果，在IIa期试验中，复发性头颈部鳞状细胞癌的客观缓解率（ORR）为43%。本研究旨在评价光免疫联合纳武单抗治疗晚期胃癌的安全性和有效性。方法：这项Ib期、开放标签、单中心试验研究了光免疫疗法联合ASP-1929和纳沃单抗在标准化疗后不可切除的egfr阳性胃腺癌患者中的应用。剂量递增部分旨在确定内镜下激光照射能量的推荐剂量，扩展部分评估在确定剂量下的安全性和有效性。主要终点是剂量限制性毒性（DLT），并评估治疗反应和不良事件。结果：在2019年10月至2022年4月期间，共有21名患者入组。所有患者之前都接受过至少2线化疗，其中6线对抗pd -1治疗有难治性。未见DLT，推荐剂量为100 J/cm2。2例患者部分缓解，ORR为9.5%。结论：本研究表明内镜下光免疫联合纳武单抗治疗晚期胃癌是安全可行的。试验注册：该试验在日本临床试验注册中心注册（标识符：jRCT2080224884， https://jrct.niph.go.jp/en-latest-detail/jRCT2080224884）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gastric Cancer 医学-胃肠肝病学

CiteScore

14.70

自引率

2.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.