NL-OMON53922尚未招募2 期
A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers - R4018-ONC-1721
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 21
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 99（—）
入选标准
- •1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically
- •confirmed diagnosis of advanced, epithelial ovarian cancer (except
- •carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of
- •the following:
- •a. serum CA-125 level >=2x upper limit of normal (ULN) (in screening)
- •b. has received at least 1 line of platinum-containing therapy or must be
- •platinum-intolerant (applicable for dose escalation and non-randomized dose
- •expansion cohorts)
- •c. documented relapse or progression on or after the most recent line of therapy
- •d. no standard therapy options likely to convey clinical benefit
- •2. Adequate organ and bone marrow function as defined in the protocol
- •3. Life expectancy of at least 3 months
- •4. Randomized phase 2 expansion cohort (Ovarian Cancer only):
- •Platinum-resistant ovarian cancer patients who have had 1 to 3 lines of
- •platinum-based therapy as defined in the protocol.
- •5. Endometrial Cancer Cohorts Only (supersedes criterion 2): histologically
- •confirmed endometrial cancer that has progressed or recurrent after prior
- •anti-PD-1 therapy and platinum-based
- •chemotherapy
- •Note: Other protocol Inclusion Criteria apply
排除标准
- •1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
- •2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic
- •chemotherapy for platinum-experienced and/or intolerant disease
- •3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
- •4. Untreated or active primary brain tumor, central nervous system (CNS)
- •metastases, or spinal cord compression
- •5. History and/ or current cardiac findings as defined in the protocol
- •6. Severe and/or uncontrolled hypertension at screening. Patients taking
- •anti-hypertensive medication must be on a stable anti-hypertensive regimen
- •Note: Other protocol Exclusion Criteria apply
研究者
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