CTIS2023-508529-29-00招募中1 期
A Phase 1 Dose Finding and Phase 2 Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors - GCT1042-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
入选标准
- •Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy., At least 18 years of age., Signed informed consent prior to any screening procedures., Measurable disease according to RECIST v1.1., Life expectancy of >3 months., Qualify for palliative SBRT as an available option for disease management., Eastern Cooperative Oncology Group (ECOG) 0-1., Normal or adequate liver, renal, cardiac and bone marrow function
排除标准
- •Prior malignancy except for non-melanoma skin cancers and in situ cancers., Condition contraindicating radiotherapy., Rapidly progressing disease., Active, known or suspected autoimmune disease., History of non-infectious pneumonitis that required steroids or currently has pneumonitis., Contraindications to the use of pembrolizumab., Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment., Received an allogeneic tissue/solid organ transplant., Active infection requiring systemic therapy. Note: Other protocol defined inclusion and exclusion criteria may apply.
研究者
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