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NCT07024615 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
A Phase 1 study of Pancreatic Ductal Adenocarcinoma, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 3
- Study locations
NCT07024615: Recruiting Phase 1 study of Pancreatic Ductal Adenocarcinoma, sponsored by Astellas Pharma Global Development.
NCT07024615 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 25 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07024615, a Phase 1 study of Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 3
- Study locations
Study Summary
Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery. In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine. People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events rel
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG 5-FU
- DRUG ASP2138
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Duke University Medical Center - Duke Cancer Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-10-16 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT07024615 shows while recruiting
NCT07024615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT07024615 reports a single indexed study location in Massachusetts, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT07024615 about?
NCT07024615 is a clinical study titled "A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer". Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people ...
What is the current status of trial NCT07024615?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2025-10-16. Estimated completion is 2028-01-31.
What conditions does trial NCT07024615 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT07024615?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), 5-FU (DRUG), ASP2138 (DRUG).
Who is sponsoring clinical trial NCT07024615?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07024615 being conducted?
This trial has 3 study locations across Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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