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

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 690 人开始时间: 2023年2月13日最近更新: 2024年1月15日

适应症

试验速览

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•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 =2 x 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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 460
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 230

•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
•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

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