A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab

Condition(s) studied

Investigational drug(s) / intervention(s)

REGN5668: Administer per the protocol

Cemiplimab: Administer per the protocol

Ubamatamab: Administer per the protocol

Sarilumab: Administer per the protocol

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]: Administer per the protocol

Study 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

Eligibility

Primary outcome measure(s)

• Incidence of Dose Limiting Toxicities (DLT) — 42 days
  Dose escalation phase, Module 1
• Incidence of DLTs — 21 days post combination administration
  Dose escalation phase, Module 2
• Incidence of Treatment-Emergent Adverse Events (TEAEs) — Through study completion, up to 5 years
  Primary: Dose escalation phase Secondary: Dose expansion phase
• Incidence of Serious Adverse Events (SAEs) — Through study completion, up to 5 years
  Primary: Dose escalation phase Secondary: Dose expansion phase
• Incidence of deaths — Through study completion, up to 5 years
  Primary: Dose escalation phase Secondary: Dose expansion phase
• 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]) — Through study completion, up to 5 years
  Primary: Dose escalation phase Secondary: Dose expansion phase
• Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab — Through study completion, up to 5 years
  Primary: Dose escalation phase
• 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) — Through study completion, up to 5 years
  Primary: Dose expansion phase

Trial sites (28)

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