A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214143
• Other study ID #: SPH-T3011-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

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