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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies

NCT ID: NCT04590326Sponsor: Regeneron PharmaceuticalsLast updated: 2025-11-21

Summary

This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer

Arms & interventions

  • DrugREGN5668

    Administer per the protocol

  • DrugCemiplimab

    Administer per the protocol

  • DrugUbamatamab

    Administer per the protocol

  • DrugSarilumab

    Administer per the protocol

  • DrugCemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

    Administer per the protocol

Outcome measures

Primary

  • Incidence of Dose Limiting Toxicities (DLT)

    Dose escalation phase, Module 1

    Time frame: 42 days

  • Incidence of DLTs

    Dose escalation phase, Module 2

    Time frame: 21 days post combination administration

  • Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Primary: Dose escalation phase Secondary: Dose expansion phase

    Time frame: Through study completion, up to 5 years

  • Incidence of Serious Adverse Events (SAEs)

    Primary: Dose escalation phase Secondary: Dose expansion phase

    Time frame: Through study completion, up to 5 years

  • Incidence of deaths

    Primary: Dose escalation phase Secondary: Dose expansion phase

    Time frame: Through study completion, up to 5 years

  • Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0])

    Primary: Dose escalation phase Secondary: Dose expansion phase

    Time frame: Through study completion, up to 5 years

  • Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab

    Primary: Dose escalation phase

    Time frame: Through study completion, up to 5 years

  • Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)

    Primary: Dose expansion phase

    Time frame: Through study completion, up to 5 years

Secondary

  • ORR based on RECIST 1.1

    Time frame: Through study completion, up to 5 years

  • Best Overall Response (BOR) based on RECIST 1.1

    Time frame: Through study completion, up to 5 years

  • Duration Of Response (DOR) based on RECIST 1.1

    Time frame: Through study completion, up to 5 years

  • Disease Control Rate (DCR) based on RECIST 1.1

    Time frame: Through study completion, up to 5 years

  • Progression-Free Survival (PFS) based on RECIST 1.1

    Time frame: Through study completion, up to 5 years

  • Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)

    Time frame: Through study completion, up to 5 years

  • Concentration of REGN5668 in serum over time when dosed alone and in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab

    Time frame: Through study completion, up to 5 years

  • Presence or absence of anti-drug antibodies against REGN5668

    Time frame: Through study completion, up to 5 years

  • Presence or absence of anti-drug antibodies against ubamatamab

    Time frame: Through study completion, up to 5 years

  • Presence or absence of anti-drug antibodies against cemiplimab

    Time frame: Through study completion, up to 5 years

  • Presence or absence of anti-drug antibodies against fianlimab

    Time frame: Through study completion, up to 5 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol. 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts) 4. Has adequate organ and bone marrow function as defined in the protocol 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has a life expectancy of at least 3 months 7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol Key Exclusion Criteria: 1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy 2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol 3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy 4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy 5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug 6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol 7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 8. Has history of clinically significant cardiovascular disease as defined in the protocol 9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s). Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study locations (13)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618

Recruiting

Chao Family Comprehensive Cancer Center

Orange, California, 92868

Recruiting

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612

Completed

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611

Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, 02215

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Recruiting

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Seattle Cancer Care Alliance at South Lake Union - G3630

Seattle, Washington, 98109

Recruiting