Evidence map›Paper›PMID 41721376›Full record

Trial reportBMC medicine2026

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.

Dongmei Ji, Wenmin Fu, Yonghong Liu, Weina Shen, Muyu Kuang, Zhouyu Ning, Youzhou Sang, Guangliang Chen, Jian Zhang, Zijie Zhou and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05602792 (A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors.), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05602792 phase1 / phase2unknown statusnot on this map

A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors.

TypeinterventionalSponsorImmVira Pharma Co. LtdRan2020 to 2024Enrolled233ConditionsAdvanced Solid Tumor, Sarcoma, HNSCC, Breast CancerArmsT3011
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Targeting PD-1Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  9. Review
  10. Review
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Dongmei Ji *Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Wenmin Fu *ImmVira Group, Suzhou, China.
Yonghong Liu *ImmVira Group, Suzhou, China.
Weina ShenDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Muyu KuangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zhouyu NingDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Youzhou SangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Guangliang ChenDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Jian ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zijie ZhouDepartment of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Dashuang XuImmVira Group, Suzhou, China.
Xu JinImmVira Group, Suzhou, China.
Junlong WuDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Xusha ZhouImmVira Group, Suzhou, China.
Jing ZhaoImmVira Group, Suzhou, China.
Lei WangImmVira Group, Suzhou, China.
Yukun LiuShenzhen International Institute for Biomedical Research, Shenzhen, China.
Xi ZhangImmVira Group, Suzhou, China.
Runbin YanImmVira Group, Suzhou, China.
Xiaoqing ChenImmVira Group, Suzhou, China.
Grace ZhouImmVira Group, Suzhou, China.
Jiaxin NiuDepartment of Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, USA. Jiaxin.niu@bannerhealth.com.
Xichun HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. huxichun2017@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOncolytic virus therapy represents a promising approach in cancer treatment due to its dual mechanisms of direct tumor lysis and immunomodulation. This study aims to evaluate the safety and efficacy of T3011, a novel oncolytic virus, administered intratumorally in patients with advanced solid tumors including head and neck squamous cell carcinoma (HNSCC).

methodsThis study comprised three parts: Part I (single-dose escalation, 2.5 × 10

resultsAmong the 87 patients treated with T3011 monotherapy in Part III, 74 were evaluable for efficacy. This group achieved an objective response rate (ORR) of 6.8% and a disease control rate (DCR) of 39.2%, with a median duration of response (DOR) of 10.6 months. Within the HNSCC cohort (n = 28), 24 patients were evaluable, showing an ORR of 12.5% and a DCR of 33.3%. Notable immune modulation was observed with increased CD8

conclusionsT3011 shows a favorable safety profile, immune-modulating effects, and preliminary efficacy in patients with advanced solid tumors.

trial registrationThis study is registered with the China Drug Trial Registry (CTR20192464) and ClinicalTrials.gov (NCT05602792).

Indexed as

Head and Neck NeoplasmsInterleukin-12Oncolytic VirotherapyOncolytic VirusesProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckAdultAgedFemaleHumansInjections, IntralesionalMaleMiddle AgedNeoplasm Recurrence, LocalTreatment OutcomeInterleukin-12PDCD1 protein, humanProgrammed Cell Death 1 ReceptorHNSCCImmune modulationImmunotherapyOncolytic virusT3011

Identifiers

PMID41721376
PMCPMC13032705

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.