NCT06403436已完成1 期
A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 13
- 主要终点
- Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.
详细描述
The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.
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
- •Males and nonpregnant and non-breastfeeding females, aged ≥ 18 years of age at the time of signing the informed consent.
- •Subjects with advanced solid tumors resistant or refractory to standard treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Measurable disease per RECIST 1.1 criteria.
- •Adequate hematological function defined by absolute neutrophil count, ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL, and without growth factor treatment or blood transfusion within 2 weeks before the study intervention start.
- •Adequate hepatic function defined by total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanine aminotransferase (ALT) level ≤ 3 × ULN.
- •Adequate renal function defined by creatinine clearance > 60 mL/min according to the Cockcroft-Gault equation or creatinine levels <1.5 mg/dl.
- •Adequate coagulation laboratory assessments, as follows: Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), or international normalized ratio (INR) < 1.5 or within target range if on prophylactic anticoagulation therapy.
- •Life expectancy of > 3 months, in the opinion of the Investigator.
- •Willing to adhere to contraception, egg and sperm donation, the fasting requirement, and other criteria as described in lifestyle restrictions
- •Capable of giving signed informed consent.
排除标准
- •Clinically significant (i.e., active) uncontrolled intercurrent illness.
- •Presence of brain metastases unless clinically stable.
- •History or presence of malignancies unless curatively treated with no evidence of disease ≥ 2 years.
- •Subjects with known human immunodeficiency virus and/or active viral hepatitis (B and/or C), and subjects on viral hepatitis B therapy are excluded. However, subjects with hepatitis C treated with curative therapy are not considered actively infected.
- •Subject received a live vaccine within 30 days prior to the first dose of the study treatment administration.
- •Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease, and/or other situation that may preclude adequate absorption of oral medications.
- •Subjects that have received a strong CYP3A4 inhibitor within 7 days prior to the first dose of TT125-802 or a strong CYP3A4 inducer within 14 days prior to the first dose of TT125-
- •Hypersensitivity to the active substance or to any of the excipients of TT125-802.
研究组 & 干预措施
TT125-802 single agent
Experimental
干预措施: TT125-802 (Drug)
结局指标
主要结局
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Day 1 to approximately 16 weeks
Frequency of dose interruptions and dose reductions
时间窗: Day 1 to approximately 16 weeks
Incidence of dose-limiting toxicities (DLTs)
时间窗: Day 1 to Day 21
Recommended Dose(s) for Expansion
时间窗: Day 1 to Day 21
次要结局
- Plasma concentration of TT125-802 in blood(Day 1 to approximately 16 weeks)
- Objective response rate (ORR) assessed by RECIST v1.1(Day 1 to approximately 16 weeks)
- Duration of response (DOR) according to RECIST v1.1(Day 1 to approximately 16 weeks)
- Progression-free survival (PFS) according to RECIST v1.1(Day 1 to approximately 16 weeks)
研究者
研究点 (13)
Loading locations...
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