A Clinical Study of T3011 in Subjects With Advanced Melanoma

Официальное название

A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma

Обзор

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

Вмешательства

• Биопрепарат T3011
  T3011 will be given intratumorally， Q2W；

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• Subjects with advanced melanoma;
• 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 within 7 days 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 · 7 центров

• Beijing Cancer Hospital — Пекин
• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• Jilin Cancer Hospital — Changchun
• Chengdu Shangjin Nanfu Hospital — Чэнду
• Fujian Cancer Hospital — Фучжоу
• The Third People's Hospital of Zhengzhou — Чжэнчжоу
• Sun Yat-sen University Cancer Center — Zhongshan

Идентификаторы

NCT: NCT06214156 · SPH-T3011-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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