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

This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: T3011 high dose; Biological: T3011 middle dose; Biological: T3011 low dose

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ye Guo; Phone Number: 0086-021-38804518; Email: pattrickguo@mail.com

Study Locations

• China
  • Anyang, China
    • Recruiting
    • Anyang Cancer Hospital
    • Contact: Yaowen Zhang
  • Bengbu, China
    • Recruiting
    • The First Affiliated Hospital of Bengbu Medical University
    • Contact: Huan Zhou
    • Contact: Chengyi Jiang
  • Changsha, China
    • Recruiting
    • Hunan Cancer Hospital
    • Contact: Feng Liu
    • Contact: Wenxiao Huang
  • Chengdu, China
    • Recruiting
    • Sichuan Cancer Hospital
    • Contact: Peng Zhang
  • Dongwan, China
    • Recruiting
    • Dongguan People's Hospital
    • Contact: Zhigang Liu
  • Fuzhou, China
    • Recruiting
    • Fujian Cancer Hospital
    • Contact: Sufang Qiu
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Contact: Jinsong Li
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Guangdong Pharmaceutical University
    • Contact: Xicheng Wang
  • Ha'erbin, China
    • Recruiting
    • Harbin Medical University Cancer Hospital
    • Contact: Jin Wu
  • Hangzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: Ying Yuan
  • Hangzhou, China
    • Recruiting
    • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Yulong Zheng
  • Jinan, China
    • Recruiting
    • Shandong Cancer Hospital
    • Contact: Man Hu
  • Nanchang, China
    • Recruiting
    • Jiangxi Cancer Hospital
    • Contact: Jingao Li
  • Nanning, China
    • Recruiting
    • Guangxi Medical University Affiliated Cancer Hospital
    • Contact: Song Qu
  • Shanghai, China
    • Recruiting
    • Shanghai East Hospital
    • Contact: Ye Guo
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Guoxin Ren
  • Shenyang, China
    • Recruiting
    • Liaoning cancer hospital
    • Contact: Zhendong Li
  • Shenzhen, China
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
    • Contact: Yan Qin
  • Taiyuan, China
    • Recruiting
    • Shanxi Cancer hospital
    • Contact: Shuqing Wei
  • Tianjin, China
    • Recruiting
    • Tianjin Cancer Hospital
    • Contact: Peiguo Wang
  • Wuhan, China
    • Recruiting
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Contact: Kunyu Yang
  • Zhengzhou, China
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Yanyan Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: T3011

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; Biological: 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; Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR)	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1	Approximately 2years
Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease	Approximately 2years
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
Progression-free survival (PFS)	From the start date of study treatment to the date of progression disease or death , whichever occurred first.	Approximately 2years
Overall Survival (OS)	Determination of the overall survival time of all patients	Approximately 2years

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SPH-T3011-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No