ASP2138 monotherapy and chemotherapy for resectable pancreatic ductal cancer (2138-CL-0102) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called ASP2138 (the study drug) is a safe and effective option for people who have pancreatic cancer that can be treated with surgery. We want to know if the study drug has a benefit when it is taken by patients before their surgery who then have standard chemotherapy after their surgery.

¿Cuál es la Condición que se está estudiando?

Cáncer de páncreas

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Are diagnosed with localized pancreatic adenocarcinoma
  • Are eligible for surgical resection of disease
  • Have not received any previous treatment for pancreatic cancer
  • Have CLDN18.2 tumor cells documented by biopsy

For more information, contact the study team at dana.a.warren@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study and are found to be eligible, you will get the study drug as an injection (shot) just under the skin for up to 4 weeks. You will then have surgery for your tumor and after you have recovered from surgery, you will get standard, approved chemotherapy drugs every 2 or 4 weeks for up to 6 months. Which chemotherapy drugs you get will be determined by your study doctor. You will have a safety follow-up visit 30 days after your last chemotherapy dose.

Detalles del Estudio

Título Completo
A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator’s Choice of Adjuvant Chemotherapy in Participants with Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression (2138-CL-0102)
Investigador Principal
Especialista en oncología médica
Número de Protocolo
IRB: PRO00117793
NCT: NCT07024615
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción