Clinical Trial 20821

Study Title

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

Summary

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

Objective

For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are:  To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR)  To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral GITR+ Treg depletion For dose escalation cohorts, the secondary objectives are:  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS)  To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab  To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts, the secondary objectives are:  To characterize the safety profile in each expansion cohort  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS  To characterize the PK of REGN6569 alone and in combination with cemiplimab  To assess the immunogenicity of REGN6569 and cemiplimab