Astellas 2138 - Clinical Trial

What is the 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 with gastroesophageal junction (GEJ) cancer or metastatic pancreatic cancer.

What is the Condition Being Studied?

Gastroesophageal Junction (GEJ) Cancer or Metastatic Pancreatic Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

- Are diagnosed with GEJ cancer or metastatic (disease that has spread) pancreatic cancer

- Have CLDN18.2 tumor cells documented by biopsy

- Are not responding to standard therapy or are not able to tolerate standard therapy

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this period, you will:

- Have a biopsy to obtain tumor tissue

- Have a physical exam

- Have blood draws

- Give urine samples

- Have a heart scan (ECG)

- Have imaging done

If you are eligible to continue on to the study after screening, you will get the study drug once per week as an infusion through a vein in your arm (IV). You will continue to receive infusions for up to 12 months.

When you stop taking the study drug, you will return to our clinic 7 days later for a follow-up exam and to have some tests done. We will schedule you to come in for 2 more follow-up visits that will happen about 30 days and 90 days after you finish taking the study drug. We will call you from time to time after your participation ends to see how you are doing.

Study Details

Full Title
A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00113995
NCT: NCT05365581
Phase I
Enrollment Status
Open for Enrollment