A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
NCT ID: NCT06214143
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2024-01-11
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T3011
T3011 high dose
T3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 middle dose
T3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 low dose
T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Interventions
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T3011 high dose
T3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 middle dose
T3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 low dose
T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Anyang Cancer Hospital
Anyang, , China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, , China
Hunan cancer hospital
Changsha, , China
Sichuan Cancer Hospital
Chengdu, , China
Dongguan People's Hospital
Dongwan, , China
Fujian Cancer Hospital
Fuzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Harbin Medical University Cancer Hospital
Ha’erbin, , China
Shandong cancer hospital
Jinan, , China
Jiangxi cancer hospital
Nanchang, , China
Guangxi Medical University Affiliated Cancer Hospital
Nanning, , China
Shanghai East Hospital
Shanghai, , China
Shanghai Ninth People's Hospital
Shanghai, , China
Liaoning Cancer Hospital
Shenyang, , China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, , China
Shanxi Cancer Hospital
Taiyuan, , China
Tianjin cancer hospital
Tianjin, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Henan cancer hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yaowen Zhang
Role: primary
Chengyi Jiang
Role: primary
Huan Zhou
Role: backup
Feng Liu
Role: primary
Wenxiao Huang
Role: backup
Peng Zhang
Role: primary
Zhigang Liu
Role: primary
Sufang Qiu
Role: primary
Jinsong Li
Role: primary
Xicheng Wang
Role: primary
Yulong Zheng
Role: primary
Ying Yuan
Role: primary
Jin Wu
Role: primary
Man Hu
Role: primary
Jingao Li
Role: primary
Song Qu
Role: primary
Ye Guo
Role: primary
Guoxin Ren
Role: primary
Zhendong Li
Role: primary
Yan Qin
Role: primary
Shuqing Wei
Role: primary
Peiguo Wang
Role: primary
Kunyu Yang
Role: primary
Yanyan Liu
Role: primary
Other Identifiers
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SPH-T3011-201
Identifier Type: -
Identifier Source: org_study_id
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