Vociprotafib

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Ensayo de Sanofi en Metastatic Neoplasm (del registro, en inglés).

Fase: Fase 1/2
Estado: Interrumpido
Participantes: 65
Centros: 20
Fin del objetivo primario: abr 2024

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2020.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor's decision not related to any safety concern».

Qué mide

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (From first dose of IMP up to 30 days after the last dose; approximately 27 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: * Part 1 * To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. * To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. * Part 2 * To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. * Part 3A * To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC * To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 3B * To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 4 * To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. * To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: * Part 1 * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * To estimate the anti-tumor effects of SAR442720 with pembrolizumab. * Part 2 * To assess the safety profile of SAR442720 combined with pembrolizumab. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * Part 3A * To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * To estimate the anti-tumor effects of SAR442720 with adagrasib * Part 3B * To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * Part 4 * To assess the safety and tolerability of SAR442720 formulations with pembrolizumab * To estimate the anti-tumor effects of SAR442720 with pembrolizumab.

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Ficha completa en ClinicalTrials.gov (NCT04418661), actualizada en may 2025.