A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Biological: T3011 high doseBiological: T3011 middle doseBiological: T3011 low dose
- Registration Number
- NCT06214143
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- Subjects with advanced solid tumors;
- At least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival > 12 weeks;
- Laboratory inspection meets the requirements;
- 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;
- 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;
- Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.
- Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
- Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
- At screening, subjects with a history or evidence of high risk cardiovascular disease;
- Subjects with persistent or active infection requiring intravenous anti-infective therapy;
- Subjects with autoimmune diseases or a history of autoimmune diseases;
- Subjects with known psychiatric disorders that may affect trial compliance;
- 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;
- Subjects requiring systemic treatment with anti-HSV drugs during the study period;
- 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;
- 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;
- Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;
- Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;
- The investigator considers it inappropriate to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description T3011 T3011 low dose - T3011 T3011 high dose - T3011 T3011 middle dose -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events Approximately 2years Adverse event type, incidence, duration
Objective response rate(ORR) Approximately 2years Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 2years From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Overall Survival (OS) Approximately 2years Determination of the overall survival time of all patients
Disease control rate (DCR) Approximately 2years DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Duration of remission (DOR) Approximately 2years DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Trial Locations
- Locations (22)
Hunan cancer hospital
🇨🇳Changsha, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Bengbu Medical University
🇨🇳Bengbu, China
Anyang Cancer Hospital
🇨🇳Anyang, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Dongguan People's Hospital
🇨🇳Dongwan, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Ha'erbin, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Guangxi Medical University Affiliated Cancer Hospital
🇨🇳Nanning, China
Shanghai East Hospital
🇨🇳Shanghai, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Jiangxi cancer hospital
🇨🇳Nanchang, China
Shandong cancer hospital
🇨🇳Jinan, 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
Fujian Cancer Hospital
🇨🇳Fuzhou, China