Calendario›SNY›SAR441000
SAR441000
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
Ensayo de Sanofi en Metastatic Neoplasm (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 77
- Centros
- 19
- Fin del objetivo primario
- jul 2022
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2019.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor terminated the study for non-safety reasons».
Qué mide
For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy) (Cycle 1; Cycle = 28 days for monotherapy) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03871348), actualizada en sep 2025.