NCT07593092招募中1 期
A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor, Inc.
- 入组人数
- 90
- 试验地点
- 13
研究概览
简要总结
The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 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 in combination with XmAb808 on participants' 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •CLDN6+ tumor
- •Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin
- •Adequate Eastern Cooperative Oncology Group performance status
- •Life expectancy ≥ 3 months
- •Adequate organ function
排除标准
- •Prior exposure to a CLDN6 targeting immune cell engager
- •Patients 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 viral hepatitis B or hepatitis C
研究组 & 干预措施
Dose Escalation and Dose Expansion of XmAb541 and XmAb808
Experimental
干预措施: XmAb808 (Biological)
Dose Escalation and Dose Expansion of XmAb541 and XmAb808
Experimental
干预措施: XmAb541 (Biological)
研究者
研究点 (13)
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