NCT04465487

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

A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	REGN6569	Administered by intravenous (IV) infusion
DRUG	Cemiplimab	Administered by IV infusion

Timeline

• Start date: 2020-10-05
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2020-07-10
• Last updated: 2025-02-24

Locations

10 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study