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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

NCT04590326 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2025-11-21

No results posted yet for this 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

Conditions

Interventions

DRUG

REGN5668

Administer per the protocol

DRUG

Cemiplimab

Administer per the protocol

DRUG

Ubamatamab

Administer per the protocol

DRUG

Sarilumab

Administer per the protocol

DRUG

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

Administer per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2027-03-25
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590326 on ClinicalTrials.gov