Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Status:
Recruiting
Trial end date:
2026-06-08
Target enrollment:
Participant gender:
Summary
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 Glucocorticoid-Induced Tumor necrosis factor
receptor-Related (GITR)+ Treg depletion
Secondary Objectives are:
For dose escalation cohorts:
- 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:
- 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