A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
A Single-arm, Multi-center Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
1 other identifier
interventional
68
1 country
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2024
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
3 years
January 9, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Approximately 2years
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Approximately 2years
Secondary Outcomes (4)
Disease control rate (DCR)
Approximately 2years
Duration of remission (DOR)
Approximately 2years
Progression-free survival (PFS)
Approximately 2years
Overall Survival (OS)
Approximately 2years
Study Arms (1)
T3011
EXPERIMENTALInterventions
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 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 19, 2024
Study Start
January 11, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04