NCT06589830招募中2 期
A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
Suzhou Teligene Ltd.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年5月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
研究概览
简要总结
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years old and above, male or female;
- •Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;
- •At least one measurable lesion;
- •Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
- •A minimum life expectancy of >3 months;
- •Adequate bone marrow reserve, hepatic, renal, and coagulation function;
- •Other inclusion criteria apply for participating in the Study. -
排除标准
- •Prior anti-HER2 targeting therapy;
- •Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;
- •Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
- •Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
- •Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
- •Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
- •Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;
- •Any active infection which has not been controlled at screening;
- •Other exclusion criteria apply for participating in the Study. -
研究组 & 干预措施
TL938-Trastuzumab combination
Experimental
TL938-Trastuzumab combination receives TL938 capsules by mouth once daily. Trastuzumab given intravenously on Day 1 of each Cycle. Cycle length is 21 days
干预措施: TL938 Capsules (Drug)
TL938-Trastuzumab combination
Experimental
TL938-Trastuzumab combination receives TL938 capsules by mouth once daily. Trastuzumab given intravenously on Day 1 of each Cycle. Cycle length is 21 days
干预措施: Trastuzumab (Drug)
TL938
Experimental
TL938 monotherapy receives TL938 capsules by mouth once daily. Cycle length is 21 days.
干预措施: TL938 Capsules (Drug)
结局指标
主要结局
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
时间窗: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
时间窗: Pre-dose up to approximately 24 months post-dose
次要结局
- Objective Response Rate (ORR) by Investigator(Pre-dose up to approximately 24 months post-dose)
- Duration of Response (DoR)(Pre-dose up to approximately 24 months post-dose)
- Disease Control Rate (DCR)(Pre-dose up to approximately 24 months post-dose)
- Progression Free Survival (PFS)(Pre-dose up to approximately 24 months post-dose)
- Time to Tumor Progression (TTP)(Pre-dose up to approximately 24 months post-dose)
- Time to Treatment Failure (TTF)(Pre-dose up to approximately 24 months post-dose)
- Time to Response (TTR)(Pre-dose up to approximately 24 months post-dose)
- Overall Survival (OS)(Pre-dose up to approximately 24 months post-dose)
- 1-year Progression Free Survival(Pre-dose up to approximately 24 months post-dose)
- 1-year Survival(Pre-dose up to approximately 24 months post-dose)
- Number of Participants Experiencing Adverse Events (AE)(Pre-dose up to approximately 24 months post-dose)
- Number of Participants Experiencing Adverse Drug Reactions (ADR)(Pre-dose up to approximately 24 months post-dose)
- Number of Participants Experiencing Serious Adverse Events (SAE)(Pre-dose up to approximately 24 months post-dose)
- Number of Participants Experiencing Serious Adverse Reactions (SAR)(Pre-dose up to approximately 24 months post-dose)
- Area Under The Curve (AUC) of TL938(Pre-dose up to 24 hours post-dose)
- Maximum Plasma Concentration (Cmax) of TL938(Pre-dose up to 24 hours post-dose)
- Minimum Plasma Concentration (Cmin) of TL938(Pre-dose up to 24 hours post-dose)
- Time to Peak Drug Concentration (Tmax) of TL938(Pre-dose up to 24 hours post-dose)
- TL938 half-life (T1/2)(Pre-dose up to 24 hours post-dose)
- Volume of Distribution (Vz/F) of TL938(Pre-dose up to 24 hours post-dose)
- Apparent Clearance (CL/f) of TL938(Pre-dose up to 24 hours post-dose)
研究者
研究点 (1)
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