Calendario›VIR›VIR-5818

VIR-5818

To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Ensayo de Vir Biotechnology, Inc. en Locally Advanced or Metastatic HER2-Expressing Cancers (del registro, en inglés).

Fase

Fase 1/2

Estado

Reclutando pacientes

Participantes

645

previstos

Centros

12

Fin del objetivo primario

abr 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2022.

Qué mide

Incidence of dose-limiting toxicity - Part 1 and Part 2 (Up to approximately 21 days (Part 1) and 42 days (Part 2)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: * Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 72 months.

Más ensayos de VIR

Todos los de VIR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05356741), actualizada en ago 2026.