Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03564340

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
890 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Conditions

Interventions

TypeNameDescription
DRUGUbamatamabAdministered per the protocol
DRUGCemiplimabAdministered per the protocol
DRUGSarilumabAdministered per the protocol
DRUGTocilizumabAdministered per the protocol

Timeline

Start date
2018-05-21
Primary completion
2026-02-01
Completion
2027-01-31
First posted
2018-06-20
Last updated
2025-12-03

Locations

51 sites across 10 countries: United States, Australia, Belgium, France, Israel, Italy, Netherlands, South Korea, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03564340. Inclusion in this directory is not an endorsement.