Combining T3011 with PD-1/PD-L1 inhibitors for 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 study is testing if a new treatment called T3011, when combined with existing cancer drugs, can help people with advanced solid tumors feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Locations: 22 sites (Anyang and 21 other locations)
• Trial ID: NCT06214143 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of T3011, administered in varying doses, in combination with PD-1/PD-L1 inhibitors for patients with advanced solid tumors. The study aims to determine the optimal dosing and effectiveness of this combination therapy. Participants will be monitored for measurable lesions and overall health status throughout the trial phases.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors who have at least one measurable lesion and meet specific health criteria.

Not a fit: Patients who have recently received other antitumor therapies or have a history of other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies combining similar immunotherapies have shown promising results, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Anyang and 21 other locations

• Anyang Cancer Hospital — Anyang, China (Recruiting)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (Recruiting)
• Hunan cancer hospital — Changsha, China (Recruiting)
• Sichuan Cancer Hospital — Chengdu, China (Recruiting)
• Dongguan People's Hospital — Dongwan, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• Harbin Medical University Cancer Hospital — Ha’erbin, China (Recruiting)
• Shandong cancer hospital — Jinan, China (Recruiting)
• Jiangxi cancer hospital — Nanchang, China (Recruiting)
• Guangxi Medical University Affiliated Cancer Hospital — Nanning, China (Recruiting)
• Shanghai East Hospital — Shanghai, China (Recruiting)
• Shanghai Ninth People's Hospital — Shanghai, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, China (Recruiting)
• Shanxi Cancer Hospital — Taiyuan, China (Recruiting)
• Tianjin cancer hospital — Tianjin, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• Henan cancer hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Ye Guo

Conditions Advanced Solid Tumors