CTIS2022-501904-83-00招募中1 期
PHASE 1/2 STUDY OF REGN5668 (MUC16 X CD28, A COSTIMULATORY BISPECIFIC) ADMINISTERED IN COMBINATION WITH CEMIPLIMAB OR REGN4018 (MUC16 X CD3) - R5668-ONC-1938
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 224 人开始时间: 2023年3月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
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+(—)
入选标准
- •Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol, Has a serum CA-125 level =2x ULN (in screening), Has adequate organ and bone marrow function as defined in the protocol, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Has a life expectancy of at least 3 months, Note: Other protocol-defined Inclusion criteria apply
排除标准
- •Prior anti-cancer immunotherapy as defined in the protocol, Note: Other protocol-defined Exclusion criteria apply, Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy, Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol, Prior treatment with a MUC16-targeted therapy, Expansion cohorts only: More than 3 prior lines of cytotoxic chemotherapy for platinum-experienced and/or intolerant disease, Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug, Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol, Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol, Has history of clinically significant cardiovascular disease as defined in the protocol
研究者
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