NCT06276491招募中1 期
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor, Inc.
- 入组人数
- 282
- 试验地点
- 23
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years
- •CLDN6+ tumor
- •Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment
- •Adequate Eastern Cooperative Oncology Group performance status
- •Life expectancy ≥ 3 months
- •Adequate liver, kidney, and bone marrow function
排除标准
- •Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.
- •Active known or suspected autoimmune disease
- •Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
- •Clinically significant cardiovascular, pulmonary or gastrointestinal disease
- •Active hepatitis B or hepatitis C
研究组 & 干预措施
Dose escalation and Dose Expansion of XmAb541
Experimental
Intravenous or Subcutaneous administration
干预措施: XmAb541 (Biological)
结局指标
主要结局
Incidence of adverse events
时间窗: Day 1 to 2 years
Incidence of cytokine release syndrome (CRS)
时间窗: Day 1 to Day 28
Incidence of dose-limiting toxicities (DLTs)
时间窗: Day 1 to Day 28
次要结局
- Measurement of Cmax(Day 1 to 2 years)
- Measurement of Ctrough(Day 1 to 2 years)
- Measurement of area under curve (AUC)(Day 1 to 1.4 years)
- Objective Response Rate(Day 1 to 2 years)
- Duration of Response(Day 1 to 2 years)
- Changes in Circulating Tumor DNA (ctDNA)(Day 1 to 4 months)
研究者
研究点 (23)
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