A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Summary

Primary Objectives: * Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. * Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: * To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. * To assess the immunogenicity of SAR441000. * To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab. * To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. * To determine the recommended dose of SAR441000 for the expansion phase.

Timeline

Start

2019-01-03

Primary completion

2022-07-25

Completion

2024-02-21

Publications

• Results Bechter O, Loquai C, Champiat S, Baurain JF, Grob JJ, Utikal J, Rottey S, Berrocal A, Hassel JC, Arance A, Sanmamed MF, Boers-Sonderen M, Gastman B, Gebhardt C, Delafontaine B, Sahin U, Tureci O, Brueck P, Abbadessa G, Marpadga R, Lee H, Yang Y, Buday B, Di Genova G, Wang H, Xia B, Lee JS, Lebbe C. A Phase I, First-in-Human, Dose-Escalation, Expansion Trial of Cytokine-Encoding Synthetic mRNA Mixture Alone or with Cemiplimab in Advanced Solid Tumors. Clin Cancer Res. 2025 Jun 13;31(12):2358-2369. doi: 10.1158/1078-0432.CCR-24-1983.

Drugs

Indications