Clinical trial · Interventional
A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
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.
NCT05602792CI-TRIAL-00061899unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Cancer | — | UNRESOLVED | — |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T3011 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T3011 Herpes Virus Injection
- interventionNames
- Biological: T3011
Primary outcomes (2)
- measure
- In part I and part II, Evaluate the safety and tolerability of escalating doses of single dose and multiple dose IT T3011.Characterize DLTs and identify the MTD of IT T3011.
- timeFrame
- Up to 2 years from first dose of T3011
- description
- Incidence rate of TEAE; Incidence rate of DLT
- measure
- In part III, Evaluate the safety of multiple dose IT T3011 in the following indications,including sarcoma, Malignant head and neck tumor, breast cancer, esophagus cancer, lung cancer and non-melanoma skin cancer.
- timeFrame
- Up to 2 years from first dose of T3011
- description
- Incidence rate of TEAE;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age 18\~70 years Part I ; Age 18 years or older (Part II and III ). 2. Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy. 3\. Measurable disease per RECIST version 1.1. 4. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator. 5\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Life expectancy \> 12 weeks. 7. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. 8\. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements. Exclusion Criteria: * 1\. Last dose of previous anticancer therapy \< 4 weeks. 2. Prior treatment with another oncolytic virus or gene therapy. 3. Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease. 4\. History of seizure disorders within 12 months of Screening. 5.History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody. 6\. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.
References
Publications (1)
- DERIVEDJi D, Fu W, Liu Y, Shen W, Kuang M, Ning Z, Sang Y, Chen G, Zhang J, Zhou Z, Xu D, Jin X, Wu J, Zhou X, Zhao J, Wang L, Liu Y, Zhang X, Yan R, Chen X, Zhou G, Niu J, Hu X. 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. BMC Med. 2026 Feb 20;24(1):177. doi: 10.1186/s12916-026-04695-1. PMID 41721376