Purpose of this Study
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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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)
Principal Investigator
Nicholas
DeVito
Protocol Number
PRO00117793
Phase
I
Enrollment Status
Pending Open to Enrollment