Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

NCT04465487 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-02-24

No results posted yet for this study

Summary

There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer.

The study is also looking at:

* Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab
* How REGN6569 and cemiplimab work in the body
* How much REGN6569 and cemiplimab is in your blood
* To see if REGN6569 can lower the number of Treg cells in tumors
* To see if REGN6569 and cemiplimab can shrink tumors when given together

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

REGN6569

Administered by intravenous (IV) infusion

DRUG

Cemiplimab

Administered by IV infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2025-02-07
Completion
2025-02-07
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

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 NCT04465487 on ClinicalTrials.gov