An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TLN-499 in combination with venetoclax in participants with relapsed/refractory 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
- •Adults ≥18 years of age
- •Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma
- •Measurable disease per RECIST v1.1 or mRECIST
- •ECOG performance status 0-1
- •Adequate hematologic, hepatic, renal, and coagulation function.
- •Life expectancy ≥12 weeks
- •Signed informed consent
排除标准
- •Active brain metastases
- •Major surgery or severe trauma within 4 weeks before first dose
- •Significant uncontrolled medical conditions preventing study participation
- •Use of prohibited concomitant medications
- •Previous conditions that would interfere with study assessments or safety
研究组 & 干预措施
Part 1 Dose Escalation and Part 2 Dose Expansion
干预措施: Venetoclax (Drug)
Part 1 Dose Escalation and Part 2 Dose Expansion
干预措施: TLN-499 (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: First 35 days of treatment
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-499
Incidence of Adverse Events and Serious Adverse Events
时间窗: Up to approximately 2 years
Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.
Overall Response Rate (ORR)
时间窗: Up to approximately 2 years
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
次要结局
- Maximum Observed Plasma Concentration (Cmax) of TLN-499(Up to approximately 2 years)
- Time to Peak Drug Concentration (Tmax) of TLN-499(Up to approximately 2 years)
- Minimum Observed Plasma Concentration (Cmin) of TLN-499(Up to approximately 2 years)
- Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)