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First-in-human phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors, including recurrent or metastatic HNSCC

Crossref DOI link: https://doi.org/10.1186/s12916-026-04695-1

Published Online: 2026-02-20

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Ji, Dongmei

Fu, Wenmin

Liu, Yonghong

Shen, Weina

Kuang, Muyu

Ning, Zhouyu

Sang, Youzhou

Chen, Guangliang

Zhang, Jian

Zhou, Zijie

Xu, Dashuang

Jin, Xu

Wu, Junlong

Zhou, Xusha

Zhao, Jing

Wang, Lei

Liu, Yukun

Zhang, Xi

Yan, Runbin

Chen, Xiaoqing

Zhou, Grace

Niu, Jiaxin

Hu, Xichun
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Text and Data Mining valid from 2026-02-20

Version of Record valid from 2026-03-27
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Article History

Received: 28 November 2025

Accepted: 5 February 2026

First Online: 20 February 2026

Declarations

:

: This clinical trial was conducted in full compliance with the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. This study was initially approved by the Ethics Committee of Fudan University Shanghai Cancer Center (ethics approval number: 1910208-16-1911). All patients provided written informed consent before participating in any study-related procedures. Confidentiality of patient information was maintained in accordance with applicable regulations and policies. The study was registered at a publicly accessible clinical trials database, ensuring transparency and accountability throughout the research process. Additionally, all potential risks and benefits of the investigational treatment were clearly communicated to patients, and the safety of participants was closely monitored throughout the trial.

: Not applicable.

: The authors declare no competing interests.

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