Trial Title:
A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
NCT ID:
NCT06214143
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
T3011 high dose
Description:
T3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1
inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Arm group label:
T3011
Intervention type:
Biological
Intervention name:
T3011 middle dose
Description:
T3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1
inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Arm group label:
T3011
Intervention type:
Biological
Intervention name:
T3011 low dose
Description:
T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered
by intravenous infusion，3 mg/kg，Q2W
Arm group label:
T3011
Summary:
This clinical study evaluated the efficacy and safety of T3011 in combination with
PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects with advanced solid tumors;
2. At least one measurable lesion;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Expected survival > 12 weeks;
5. Laboratory inspection meets the requirements;
6. For women of childbearing potential, the serum pregnancy test results must be
negative prior to the first dose，and effective contraceptive measures must be taken
from signing the informed consent form (ICF) until at least 6 months after the last
dose;
7. Male subjects of childbearing potential agree to use effective contraception from
signing the ICF until at least 6 months after the last dose; In addition, male
subjects must agree not to donate sperm during this period;
8. Understand and voluntarily sign the ICF，willing and able to comply with all
experimental requirements.
Exclusion Criteria:
1. Subjects who have received other antitumor therapy within the prescribed time prior
to the first dose;
2. Subjects with a history of other malignancies within the prescribed time prior to
the start of study treatment.
3. At screening, subjects with a history or evidence of high risk cardiovascular
disease;
4. Subjects with persistent or active infection requiring intravenous anti-infective
therapy;
5. Subjects with autoimmune diseases or a history of autoimmune diseases;
6. Subjects with known psychiatric disorders that may affect trial compliance;
7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting
treatment and require puncture drainage, or who had received puncture drainage
within the specified time before starting the study treatment;
8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;
9. Subjects who have received live or attenuated vaccines within the prescribed time
prior to the first dose, or who plan to receive such vaccines during the study
period; Subjects who have received any tumor vaccine in the past;
10. Subjects who had undergone major surgery within the prescribed time before the first
dose，and had not recovered from surgery-related adverse reactions or were still in
the postoperative recovery period，or who plan to undergo major surgery during the
study period;
11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year
prior to signing the ICF;
12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have
children during the study period;
13. The investigator considers it inappropriate to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yaowen Zhang
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical University
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Chengyi Jiang
Contact backup:
Last name:
Huan Zhou
Facility:
Name:
Hunan cancer hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Liu
Contact backup:
Last name:
Wenxiao Huang
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang
Facility:
Name:
Dongguan People's Hospital
Address:
City:
Dongwan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhigang Liu
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sufang Qiu
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinsong Li
Facility:
Name:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xicheng Wang
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Ha'erbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Wu
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yulong Zheng
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Yuan
Facility:
Name:
Shandong cancer hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Man Hu
Facility:
Name:
Jiangxi cancer hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingao Li
Facility:
Name:
Guangxi Medical University Affiliated Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Song Qu
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo
Facility:
Name:
Shanghai Ninth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoxin Ren
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhendong Li
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Qin
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuqing Wei
Facility:
Name:
Tianjin cancer hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Peiguo Wang
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kunyu Yang
Facility:
Name:
Henan cancer hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanyan Liu
Start date:
January 11, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06214143
