Calendario›REGN›REGN5459
REGN5459
First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
Ensayo de REGENERON PHARMACEUTICALS, INC. en Relapsed Multiple Myeloma · Refractory Multiple Myeloma (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 43
- Centros
- 7
- Fin del objetivo primario
- may 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2019.
Qué mide
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period (del registro, en inglés) (hasta 35 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroIn the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit. In the phase 2 portion of the study, the primary objective is to assess the preliminary anti-tumor activity of REGN5459 as measured by objective response rate (ORR). In the phase 1 and phase 2 portion, the secondary objectives of the study are: * To assess the preliminary anti-tumor activity of REGN5459 as measured by duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS) * To evaluate the pharmacokinetic (PK) properties of REGN5459 * To characterize the immunogenicity of REGN5459 * To evaluate the effects of REGN5459 on patient-reported quality of life (QoL), symptoms, functioning and general health status In the phase 1 portion of the study only, the secondary objective of the study is to assess the preliminary anti-tumor activity of REGN5459 as measured by ORR. In the phase 2 portion of the study only, the secondary objective of the study is to evaluate the safety and tolerability of REGN5459.
Más ensayos de REGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| cemiplimab | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Pozelimab + Cemdisiran · NIMBLE | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Garetosmab · OPTIMA | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Aflibercept 8 mg · ELARA | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Dupilumab · ENGAGE | Fase 2 | En marcha, sin reclutar | feb 2026 (real) |
| Fianlimab | Fase 3 | En marcha, sin reclutar | mar 2026 (real) |
Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04083534), actualizada en abr 2026.