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

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 689 人开始时间: 2024年5月28日最近更新: 2024年7月22日

试验速览

暂无简介。

•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: serum CA-125 level =2 x upper limit of normal (ULN) (in screening); 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); documented relapse or progression on or after the most recent line of therapy; no standard therapy options likely to convey clinical benefit, Adequate organ and bone marrow function as defined in the protocol, Life expectancy of at least 3 months, 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., Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy: MUC16 positivity of tumor cells =25% by immunohistochemistry (IHC); 1-2 prior lines of systemic therapy, Other protocol-defined inclusion criteria apply

•Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol, Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy, Prior treatment with a MUC16 - targeted therapy, Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol, History and/or current cardiac findings as defined in the protocol, Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen, Other protocol-defined exclusion criteria apply

发起方

Regeneron Pharmaceuticals Inc.