Calendario›ZLAB›Tisotumab Vedotin

Tisotumab Vedotin

To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

Ensayo de Zai Lab Ltd en Solid Malignancies (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

19

previstos

Centros

1

Fin del objetivo primario

nov 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2023.

Qué mide

PK parameter AUC of tisotumab vedotin (At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are: * How is the PK of tisotumab vedotin? * How is the immunogenicity of tisotumab vedotin? * How is the safety and tolerability of tisotumab vedotin? * How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population. Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Más ensayos de ZLAB

Todos los de ZLAB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05866354), actualizada en nov 2023.