NCT06214156招募中1 期
A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
T3011
Experimental
干预措施: T3011 (Biological)
结局指标
主要结局
Objective response rate(ORR)
时间窗: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Incidence of Treatment-Emergent Adverse Events
时间窗: Approximately 2 years
Adverse event type, incidence, duration
次要结局
- Disease control rate (DCR)(Approximately 2 years)
- Duration of remission (DOR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
- Overall Survival (OS)(Approximately 2 years)
研究者
研究点 (7)
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