Trial Title:
A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
NCT ID:
NCT05602792
Condition:
Advanced Solid Tumor
Sarcoma
HNSCC
Breast Cancer
Esophagus Cancer
NSCLC
Non-melanoma Skin Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Oncolytic virus
Herpes virus
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with advanced solid
tumors.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with sarcoma.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with Malignant head
and neck tumor.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with breast cancer.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with esophagus
cancer.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with lung cancer.
Arm group label:
T3011 Herpes Virus Injection
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be administered through intratumoral injection in patients with non-melanoma
skin cancer.
Arm group label:
T3011 Herpes Virus Injection
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Gang, Professor
Phone:
0551-62283114
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
The Second Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen Zhendong, Professor
Phone:
0551-63869420
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
The Fifth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guanzhou
Zip:
528406
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Siyang, Professor
Phone:
0756-2528888
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Weitao, Professor
Phone:
400-0371818
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Feng, Professor
Phone:
0371-67966266
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen Jing, Professor
Phone:
027-85726114
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Huang Gang, Professor
Phone:
0731-88651900
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Zhiwei, Professor
Phone:
0791-88313632
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhendong, Professor
Phone:
024-31916684
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Deng Yaotiao, Professor
Phone:
028-85422114
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
The First Affiliated Hospital of Zhejiang University Medical College
Address:
City:
Hanzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Yulong, Professor
Phone:
0571-87236114
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hanzhou
Zip:
314408
Country:
China
Status:
Recruiting
Contact:
Last name:
Tong Xiangmin, Professor
Phone:
0571-87666666
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Hang, Professor
Phone:
010-83572211
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Beijing Jishuitan Hospital
Address:
City:
Beijing
Zip:
100035
Country:
China
Status:
Recruiting
Contact:
Last name:
Niu Xiaohui, Professor
Phone:
010-58516688
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
Address:
City:
Shanghai
Zip:
200011
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhang Chenping
Phone:
23271699
Phone ext:
5818
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Ji Dongmei, Professor
Phone:
021-64175590
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Yuhong, Professor
Phone:
021-64041990
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Zip:
200233
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shen Zan, Professor
Phone:
021-64369181
Email:
clinicaltrials@immviragroup.com
Facility:
Name:
The Second People's Hospital of Shenzhen
Address:
City:
Shenzhen
Zip:
518025
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Guowen, Professor
Phone:
0755-88698000
Email:
clinicaltrials@immviragroup.com
Start date:
April 21, 2020
Completion date:
January 2024
Lead sponsor:
Agency:
ImmVira Pharma Co. Ltd
Agency class:
Industry
Source:
ImmVira Pharma Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602792
