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Eftilagimod Alpha · AIPAC-002

A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti (IMP321, Eftilagimod Alpha) as Adjunctive to a Weekly Treatment Regimen of Paclitaxel

Ensayo de IMMUTEP Ltd en Cancer de mama metastasico.

Más ensayos de: Cáncer de mama metastásico.

Fase

Fase 1

Estado

Retirado antes de empezar

Fin del objetivo primario

jun 2025

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Replaced by other study NCT05747794».

Qué mide

Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day (del registro, en inglés) (hasta 12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.

Más ensayos de IMMP

Todos los de IMMP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04252768), actualizada en mar 2023.