Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific) Administered in Combination With Cemiplimab or REGN4018 (MUC16xCD3) Eligibility Criteria

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. Prior anti-cancer immunotherapy as defined in the protocol
  2. Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy
  3. 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
  4. Prior treatment with a MUC16-targeted therapy
  5. Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (including antibody drug conjugates)
  6. 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
  7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
  8. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
  9. Has history of clinically significant cardiovascular disease as defined in the protocol
  10. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).