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

Study Identifier:
R5668-ONC-1938
CT.gov Identifier:
NCT04590326
EudraCT Identifier:
2020-000063-23
EU Trial (CTIS) Number:
2022-501904-83-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To investigate MUC16xCD28 (REGN5668) in combination with either Libtayo or MUC16xCD3 (REGN4018) for ovarian cancer.

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) 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

To assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of REGN5668 with cemiplimab (Module 1) or REGN4018 (Module 2) in pts with rOVCA.

To study the intravenous (IV) R5668 combined with cemi in patients (pts) with recurrent platinum-experienced ovarian cancer (OC).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Ovarian
  • Fallopian Tube
  • Primary Peritoneal
  • Endometrial
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female
    Age
    18+ years
    Study Drug
  • Drug: Patients will recieve MUC16xCD28 (REGN5668) in combination with either Libtayo or MUC16xCD3 (REGN4018).
    • Read More
  • Drug: Experimental: Module 1
  • Drug: Drug: Cemiplimab
  • Drug: Drug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
  • Drug: Experimental: Module 2
  • Drug: Drug: Ubamatamab
  • Drug: Drug: Sarilumab
  • Drug: ASCO 2021:
  • Drug: SGO 2023:
  • Drug: Patients with recurrent ovarian cancer, who received infusions of REGN5668 once-weekly at a dose range of 0.3-300 mg, with the addition of Libtayo infusions every three weeks beginning between day 21 and 28.
  • Drug: Pts received weekly R5668 IV at a dose range of 0.3-300 mg. Cemi 350 mg IV every 3 weeks was added beginning Day 21-28.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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
    • Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
    • Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
    • Has adequate organ and bone marrow function as defined in the protocol
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Has a life expectancy of at least 3 months
    • 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
    Exclusion criteria
    • Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
    • 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
    • Prior treatment with a Mucin 16 (MUC16)-targeted therapy
    • Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
    • 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
    • Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
    • Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
    • Has history of clinically significant cardiovascular disease as defined in the protocol
    • Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
    • Note: Other protocol-defined Inclusion/Exclusion criteria apply

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Fallopian Tube
    Primary Peritoneal
    Endometrial