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
- Conditions
- Recurrent Ovarian Cancer / Ovarian Cancer10038594
- Registration Number
- NL-OMON53922
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 21
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In the dose escalation phase:<br /><br>Dose-limiting toxicities, treatment-emergent adverse events (TEAEs; including<br /><br>immune-related adverse events [imAEs]), serious AEs (SAEs), deaths, laboratory<br /><br>abnormalities (grade 3 or higher per CTCAE), and PK for monotherapy and in<br /><br>combination with cemiplimab<br /><br><br /><br>In the dose expansion phase:<br /><br>• ORR defined by RECIST 1.1 for both monotherapy and in combination with<br /><br>cemiplimab</p><br>
- Secondary Outcome Measures
Name Time Method