ASP2138 for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called ASP2138 for surgically removable pancreatic ductal cancer. ASP2138 is designed to help the immune system attack cancer cells by targeting a specific protein in the tumor. Participants will receive an injection of ASP2138 before surgery, followed by standard chemotherapy treatments. The trial seeks individuals with pancreatic cancer who have not yet received treatment and whose tumors can be surgically removed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have received any prior therapy for your pancreatic cancer. It's best to discuss your current medications with the study doctor to see if they might affect your eligibility.
Is there any evidence suggesting that ASP2138 is likely to be safe for humans?
Research has shown that ASP2138 is being tested for safety in individuals with certain cancers, such as pancreatic cancer. In earlier studies, researchers administered ASP2138 alone or with other standard treatments. These studies aimed to assess how well participants tolerated ASP2138 and to determine the appropriate dose.
Results indicated that ASP2138 is generally well-tolerated. Most side effects were mild to moderate, with some participants experiencing fatigue or injection site reactions, though these were not severe. Serious side effects were rare. However, as with any new treatment, risks exist. ASP2138 remains in the early stages of testing, so researchers continue to learn about its safety.
Prospective clinical trial participants should discuss any concerns with their doctor. A doctor can explain the trial's details and potential risks.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Researchers are excited about ASP2138 for pancreatic cancer because it introduces a promising new approach by utilizing a novel mechanism of action. Unlike current treatments that primarily focus on chemotherapy combinations like mFOLFIRINOX or Gemcitabine-based regimens, ASP2138 is administered prior to surgery, potentially enhancing the effectiveness of subsequent chemotherapy. This pre-surgical treatment aims to shrink tumors and improve surgical outcomes, offering a fresh hope in tackling this aggressive cancer. Additionally, combining ASP2138 with personalized chemotherapy choices post-surgery could pave the way for more tailored and effective treatment strategies.
What evidence suggests that ASP2138 might be an effective treatment for pancreatic cancer?
Research has shown that ASP2138, which participants in this trial may receive, targets a protein called Claudin 18.2 (CLDN18.2) found in some pancreatic cancer tumors. This treatment attaches to CLDN18.2 and a protein on T-cells, a type of immune cell. The T-cells then assist the immune system in attacking the tumor. Although specific data on ASP2138's effectiveness in pancreatic cancer is still being gathered, similar methods have shown promise in other cancers with CLDN18.2. Early findings suggest that targeting this protein could offer a new way to effectively treat pancreatic cancer.12467
Who Is on the Research Team?
Associate Medical Director
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with resectable pancreatic ductal cancer, meaning the tumor can be surgically removed. Participants must have a protein called CLDN18.2 in their tumors to qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive ASP2138 injection subcutaneously for up to 4 weeks before surgery
Surgery
Participants undergo surgical resection of the pancreatic tumor
Adjuvant Chemotherapy
Participants receive standard chemotherapy treatments for up to 6 months post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a final clinic visit about a month after finishing chemotherapy
What Are the Treatments Tested in This Trial?
Interventions
- ASP2138
- Standard Chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available