Zolbetuximab + Chemotherapy for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using strong inhibitors or inducers of CYP3A or UGT1A1 with irinotecan, you may need to adjust your medication. It's best to discuss your current medications with the study team.
Is the combination of Zolbetuximab and chemotherapy safe for humans?
The modified FOLFIRINOX (mFOLFIRINOX) chemotherapy regimen, which is part of the treatment being studied, has been associated with increased toxicity, including peripheral neuropathy (nerve damage causing tingling or numbness). This suggests that while it can be effective, it may also have significant side effects.12345
What is the purpose of this trial?
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.There are 2 main aims of this study:* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.
Research Team
Medical Director
Principal Investigator
Astellas Pharma Global Development, Inc.
Eligibility Criteria
Adults over 18 with metastatic pancreatic cancer who haven't had chemotherapy can join this study. They must have a specific protein on their tumor cells and not be pregnant or breastfeeding. Participants need measurable cancer lesions, cannot have progressed after certain chemotherapies, and women must agree to contraception for six months post-treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zolbetuximab in combination with chemotherapy (mFOLFIRINOX) every 14 days in a 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, including health checks and blood tests
Treatment Details
Interventions
- mFOLFIRINOX
- Zolbetuximab
mFOLFIRINOX is already approved in European Union, United States, Canada for the following indications:
- Pancreatic ductal adenocarcinoma (PDAC)
- Advanced pancreatic cancer
- Resectable pancreatic ductal adenocarcinoma
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