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BioNTech_BNT326-01 (Advanced Solid Tumors) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find the most effective, safe dose of an experimental drug called BNT326. We want to know how well it works when it is given on its own and in combination with an immunotherapy drug.
¿Cuál es la Condición que se está estudiando?
Advanced Solid Tumors
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are diagnosed with a solid tumor form of cancer (e.g., cutaneous melanoma, rare melanoma, non-small cell lung cancer, breast cancer)
- Have disease that has either relapsed or is metastatic (has spread)
- Do not have disease that has the potential to be resolved with surgery and/or radiation or ablation)
For more information, contact the study team at hollie.watson@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
If you choose to join this study, you will participate in either Part 1 or Part 2 of the study. La parte del estudio en la que participe dependerá de cuándo se incorpore al estudio.
- Part 1: If you participate in this study, you will take the study drug on its own. You will get a dose of the study drug every 3 weeks.
- Part 2: If you participate in this study, you will take the study drug in combination with an experimental immunotherapy drug called BNT327. You will get a dose of both drugs every 3 weeks.
Detalles del Estudio
Título Completo
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy,
optimal dose and pharmacokinetics of BNT326 as monotherapy and in
combination with cancer immunotherapies in participants with advanced solid
tumors.
Investigador Principal
Especialista en oncología médica
Número de Protocolo
IRB:
PRO00117681
NCT:
NCT07070232
Fase
Phase
I/II
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción