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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

NCT ID: NCT03564340Sponsor: Regeneron PharmaceuticalsLast updated: 2026-05-08

Summary

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Arms & interventions

  • DrugUbamatamab

    Administered per the protocol

  • DrugCemiplimab

    Administered per the protocol

  • DrugSarilumab

    Administered per the protocol

  • DrugTocilizumab

    Administered per the protocol

Outcome measures

Primary

  • Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: From Cycle 1, Day 1 up to 35 days

  • Number of participants with DLTs for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: From Cycle 2, Day 1 up to 21 days

  • Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of participants with SAEs for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of deaths for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of deaths for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Concentration of ubamatamab in serum over time for ubamatamab monotherapy

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

    Dose Escalation Phase

    Time frame: Up to 2 years

  • Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy

    Dose Expansion Phase

    Time frame: Up to 2 years

  • ORR defined by RECIST 1.1 for ubamatamab with cemiplimab

    Dose Expansion Phase

    Time frame: Up to 2 years

Secondary

  • ORR based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • ORR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Number of participants with SAEs for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Number of participants with SAEs for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Number of deaths for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Number of deaths for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Concentration of ubamatamab in serum over time for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

  • Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

  • Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

  • Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

  • Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

  • Change from baseline in abdominal symptoms as measured by the MOST-Abdominal index score for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

  • Time to deterioration in GHS/QoL for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Time to deterioration in GHS/QoL for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Time to deterioration in physical functioning for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Time to deterioration in physical functioning for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Time to deterioration in abdominal symptoms for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Time to deterioration in abdominal symptoms for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy

    Time frame: Baseline up to 2 years

  • Change from baseline in QoL as measured by EQ-5D for ubamatamab with cemiplimab

    Time frame: Baseline up to 2 years

  • ORR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

  • ORR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Best overall response (BOR) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • BOR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

  • BOR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • BOR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Duration of response (DOR) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • DOR based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

  • DOR based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • DOR based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Disease control rate based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Disease control rate based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

  • Disease control rate based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Disease control rate based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Complete response (CR) rate based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • CR rate based on iRECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • CR rate based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • CR rate based on iRECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Progression-free survival (PFS) based on RECIST 1.1 for ubamatamab monotherapy

    Time frame: Up to 2 years

  • PFS based on iRECIST for ubamatamab monotherapy

    Time frame: Up to 2 years

  • PFS based on RECIST 1.1 for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • PFS based on iRECIST for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Cancer antigen-125 (CA-125) response for ubamatamab monotherapy

    Time frame: Up to 2 years

  • CA-125 response for ubamatamab with cemiplimab

    Time frame: Up to 2 years

  • Presence or absence of anti-drug antibodies against ubamatamab

    Time frame: Up to 2 years

  • Presence or absence of anti-drug antibodies against cemiplimab

    Time frame: Up to 2 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: 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: 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma) 2. 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) 3. documented relapse or progression on or after the most recent line of therapy 4. 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 2 to 4 lines of platinum-based therapy as defined in the protocol. 5. 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: 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol 2. 1-4 prior lines of systemic therapy, as described in the protocol Key Exclusion Criteria: 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol 2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort) 3. Prior treatment with a MUC16 - targeted therapy 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol 5. History and/or current cardiovascular disease, 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-defined Inclusion/Exclusion Criteria apply

Study locations (11)

University of Alabama_6th Ave

Birmingham, Alabama, 35294

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Dana Farber / Harvard Cancer Center

Boston, Massachusetts, 02215

Recruiting

Mayo Clinic - Rochester

Rochester, Minnesota, 55901

Recruiting

Roswell Park Cancer Institute

Buffalo, New York, 14263

Withdrawn

Columbia University Medical Center

New York, New York, 10032

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

The Ohio State University Wexner Medical Center James Comprehensive Cancer Center

Hilliard, Ohio, 43026

Recruiting

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

Virginia Commonwealth University

Richmond, Virginia, 23219

Recruiting