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eftilagimod alpha · AIPAC-003
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy
Ensayo de IMMUTEP Ltd en Carcinoma de mama.
- Fase
- Fase 2/3
- Estado
- Interrumpido
- Participantes
- 72
- Centros
- 22
- Fin del objetivo primario
- abr 2026
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en may 2023.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor Decision».
Qué mide
Determinacion de la supervivencia global (SG) (Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy? * Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Más ensayos de IMMP
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| eftilagimod alfa | Fase 3 | En marcha, sin reclutar | jun 2027 (prevista) |
| IMP761 | Fase 1 | Completado | ago 2026 (real) |
| Eftilagimod Alpha · AIPAC-002 | Fase 1 | Retirado antes de empezar | jun 2025 (prevista, ya pasada: sin actualizar en el registro) |
| eftilagimod alpha · TACTI-003 | Fase 2 | Completado | mar 2024 (real) |
| eftilagimod alpha · TACTI-002 | Fase 2 | Completado | jun 2022 (real) |
| IMP321 | Fase 2 | Completado | mar 2020 (real) |
Todos los de IMMP, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05747794), actualizada en jul 2026.