NCT06651593

Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

Detailed description

Primary Objective * To identify biomarkers: * Related to the mechanism of action of SAR444881 alone and in combination with cemiplimab in participants with solid tumors * Predictive of response/survival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors * To evaluate the association of biomarkers with response/survival and resistance\*: * Objective response rate (ORR) * Clinical benefit rate (CBR) * Progression-free survival (PFS) * Overall survival (OS) Secondary Objectives * To evaluate the efficacy of the SAR444881 and cemiplimab combination * To determine the safety and tolerability of the SAR444881 and cemiplimab combination

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	SAR444881	Given by IV
DRUG	Cemiplimab	Given by Iv

Timeline

• Start date: 2025-07-02
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2024-10-21
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study