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

Официальное название

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

Обзор

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

Вмешательства

• Биопрепарат 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
• Биопрепарат 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
• Биопрепарат 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

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 2years]
• Objective response rate(ORR) [Срок оценки: Approximately 2years]

Вторичные конечные точки (4)

• Disease control rate (DCR) [Срок оценки: Approximately 2years]
• Duration of remission (DOR) [Срок оценки: Approximately 2years]
• Progression-free survival (PFS) [Срок оценки: Approximately 2years]
• Overall Survival (OS) [Срок оценки: Approximately 2years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 22 центра

• Anyang Cancer Hospital — Anyang
• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Hunan cancer hospital — Чанша
• Sichuan Cancer Hospital — Чэнду
• Dongguan People's Hospital — Dongwan
• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Гуанчжоу
• … и ещё 14 центров

Идентификаторы

NCT: NCT06214143 · SPH-T3011-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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