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.
1 other identifier
interventional
233
1 country
19
Brief Summary
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
Typical duration for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2020
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedNovember 2, 2022
October 1, 2022
3.2 years
October 18, 2022
October 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Incidence rate of TEAE; Incidence rate of DLT
Up to 2 years from first dose of T3011
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.
Incidence rate of TEAE;
Up to 2 years from first dose of T3011
Secondary Outcomes (8)
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
Up to 2 years from first dose of T3011
In part I and part II, Evaluation of pharmacodynamics of T3011
Up to 2 years from first dose of T3011
In part I and part II, Evaluation of immunogenicity of T3011
Up to 2 years from first dose of T3011
Overall response rate (ORR)
Up to 2 years from first dose of T3011
Disease control rate (DCR)
Up to 2 years from first dose of T3011
- +3 more secondary outcomes
Other Outcomes (3)
In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011
Up to 2 months from first dose of T3011
In part II and part III,Exploring the relationship between genetic changes and drug efficacy
Up to 2 months from first dose of T3011
In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011
Up to 2 years from first dose of T3011
Study Arms (1)
T3011 Herpes Virus Injection
EXPERIMENTALInterventions
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
Eligibility Criteria
You may qualify if:
- \. 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.
- \. 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.
- \. 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.
- \. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements.
You may not qualify if:
- \. 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.
- \. 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.
- \. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, 528406, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
The First Affiliated Hospital of Zhejiang University Medical College
Hanzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital
Hanzhou, Zhejiang, 314408, China
Peking University First Hospital
Beijing, 100034, China
Beijing Jishuitan Hospital
Beijing, 100035, China
Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
Shanghai, 200011, China
Fudan University Cancer Hospital
Shanghai, 200032, China
Zhongshan Hospital
Shanghai, 200032, China
Shanghai Sixth People's Hospital
Shanghai, 200233, China
The Second People's Hospital of Shenzhen
Shenzhen, 518025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
November 2, 2022
Study Start
April 21, 2020
Primary Completion
July 1, 2023
Study Completion
January 1, 2024
Last Updated
November 2, 2022
Record last verified: 2022-10