Back to resultsA Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
Primary Purpose
Advanced Solid Tumor, Sarcoma, HNSCC
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
T3011
T3011
T3011
T3011
T3011
T3011
T3011
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Oncolytic virus, Herpes virus
Eligibility Criteria
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.
Sites / Locations
- Anhui Provincial HospitalRecruiting
- The Second Hospital of Anhui Medical UniversityRecruiting
- The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Henan Cancer HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Wuhan Union HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- Jiangxi Cancer HospitalRecruiting
- Liaoning Cancer HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- The First Affiliated Hospital of Zhejiang University Medical CollegeRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Peking University First HospitalRecruiting
- Beijing Jishuitan HospitalRecruiting
- Ninth People's Hospital,Shanghai Jiao Tong University School to MedicineRecruiting
- Fudan University Cancer HospitalRecruiting
- Zhongshan HospitalRecruiting
- Shanghai Sixth People's Hospital
- The Second People's Hospital of ShenzhenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T3011 Herpes Virus Injection
Arm Description
Outcomes
Primary Outcome Measures
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
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;
Secondary Outcome Measures
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
The changes of PD-1 and IL-12 concentration after administration
In part I and part II, Evaluation of pharmacodynamics of T3011
IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α
In part I and part II, Evaluation of immunogenicity of T3011
ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Disease control rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Duration of response (DOR)
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Progression-free survival (PFS)
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
In part III,Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Full Information
NCT ID
NCT05602792
First Posted
October 18, 2022
Last Updated
October 30, 2022
Sponsor
ImmVira Pharma Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05602792
Brief Title
A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmVira Pharma Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Detailed Description
This is a Phase I/IIa, open-label, first-in-human study of T3011 given via intratumoral (IT) injection in participants with advanced or metastatic solid tumors. Part I and part II of the study is a dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Part I is a single dose escalation. Part II is multiple dose escalation. Total enrollment will depend on the toxicities and/or activity observed, with approximately 8-48 evaluable participants enrolled.
Once the RP2D is established ,Part III will enroll approximately 40-60 participants with sarcoma , approximately 10-25 participants with Malignant head and neck tumor,approximately 10-25 participants with breast cancer,approximately 10-25 participants with esophagus cancer,approximately 10-25 participants with lung cancer and approximately 10-25 participants with non-melanoma skin cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Sarcoma, HNSCC, Breast Cancer, Esophagus Cancer, NSCLC, Non-melanoma Skin Cancer
Keywords
Oncolytic virus, Herpes virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
233 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T3011 Herpes Virus Injection
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with sarcoma.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with breast cancer.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with lung cancer.
Intervention Type
Biological
Intervention Name(s)
T3011
Intervention Description
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.
Primary Outcome Measure Information:
Title
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.
Description
Incidence rate of TEAE; Incidence rate of DLT
Time Frame
Up to 2 years from first dose of T3011
Title
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.
Description
Incidence rate of TEAE;
Time Frame
Up to 2 years from first dose of T3011
Secondary Outcome Measure Information:
Title
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
Description
The changes of PD-1 and IL-12 concentration after administration
Time Frame
Up to 2 years from first dose of T3011
Title
In part I and part II, Evaluation of pharmacodynamics of T3011
Description
IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α
Time Frame
Up to 2 years from first dose of T3011
Title
In part I and part II, Evaluation of immunogenicity of T3011
Description
ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1
Time Frame
Up to 2 years from first dose of T3011
Title
Overall response rate (ORR)
Description
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Time Frame
Up to 2 years from first dose of T3011
Title
Disease control rate (DCR)
Description
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Time Frame
Up to 2 years from first dose of T3011
Title
Duration of response (DOR)
Description
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to 2 years from first dose of T3011
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
Time Frame
Up to 2 years from first dose of T3011
Title
In part III,Overall Survival (OS)
Description
OS is defined as the time from enrollment to death from any cause.
Time Frame
Up to 2 years from first dose of T3011
Other Pre-specified Outcome Measures:
Title
In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011
Description
Assesse histological changes by immunohistochemical fluorescence detection
Time Frame
Up to 2 months from first dose of T3011
Title
In part II and part III,Exploring the relationship between genetic changes and drug efficacy
Description
Genetic testing of tumor tissue
Time Frame
Up to 2 months from first dose of T3011
Title
In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011
Description
Analysis of immune cells in blood
Time Frame
Up to 2 years from first dose of T3011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ImmVira Pharma Co. LTD
Phone
781-718-5121
Email
clinicaltrials@immviragroup.com
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Gang, Professor
Phone
0551-62283114
Email
clinicaltrials@immviragroup.com
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Zhendong, Professor
Phone
0551-63869420
Email
clinicaltrials@immviragroup.com
Facility Name
The Fifth Affiliated Hospital of Sun Yat-sen University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
528406
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Siyang, Professor
Phone
0756-2528888
Email
clinicaltrials@immviragroup.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Weitao, Professor
Phone
400-0371818
Email
clinicaltrials@immviragroup.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Feng, Professor
Phone
0371-67966266
Email
clinicaltrials@immviragroup.com
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Jing, Professor
Phone
027-85726114
Email
clinicaltrials@immviragroup.com
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Gang, Professor
Phone
0731-88651900
Email
clinicaltrials@immviragroup.com
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhiwei, Professor
Phone
0791-88313632
Email
clinicaltrials@immviragroup.com
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhendong, Professor
Phone
024-31916684
Email
clinicaltrials@immviragroup.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deng Yaotiao, Professor
Phone
028-85422114
Email
clinicaltrials@immviragroup.com
Facility Name
The First Affiliated Hospital of Zhejiang University Medical College
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Yulong, Professor
Phone
0571-87236114
Email
clinicaltrials@immviragroup.com
Facility Name
Zhejiang Provincial People's Hospital
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
314408
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Xiangmin, Professor
Phone
0571-87666666
Email
clinicaltrials@immviragroup.com
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Hang, Professor
Phone
010-83572211
Email
clinicaltrials@immviragroup.com
Facility Name
Beijing Jishuitan Hospital
City
Beijing
ZIP/Postal Code
100035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niu Xiaohui, Professor
Phone
010-58516688
Email
clinicaltrials@immviragroup.com
Facility Name
Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Chenping
Phone
23271699
Ext
5818
Email
clinicaltrials@immviragroup.com
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Dongmei, Professor
Phone
021-64175590
Email
clinicaltrials@immviragroup.com
Facility Name
Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Yuhong, Professor
Phone
021-64041990
Email
clinicaltrials@immviragroup.com
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Zan, Professor
Phone
021-64369181
Email
clinicaltrials@immviragroup.com
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
ZIP/Postal Code
518025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Guowen, Professor
Phone
0755-88698000
Email
clinicaltrials@immviragroup.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
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