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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06214143
Other study ID # SPH-T3011-201
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 11, 2024
Est. completion date May 31, 2026

Study information

Verified date January 2024
Source Shanghai Pharmaceuticals Holding Co., Ltd
Contact Ye Guo
Phone 0086-021-38804518
Email pattrickguo@mail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date May 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
China 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 Harbin Medical University Cancer Hospital Ha'erbin
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou
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

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Adverse event type, incidence, duration Approximately 2years
Primary 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 Disease control rate (DCR) DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease Approximately 2years
Secondary Duration of remission (DOR) 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. Approximately 2years
Secondary Progression-free survival (PFS) From the start date of study treatment to the date of progression disease or death , whichever occurred first. Approximately 2years
Secondary Overall Survival (OS) Determination of the overall survival time of all patients Approximately 2years
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