Zolbetuximab + Chemotherapy for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you need to take medicines that suppress your immune system or if you have recently taken certain treatments like radiotherapy or investigational drugs. It's best to discuss your specific medications with the study doctor.
What data supports the effectiveness of the drug Zolbetuximab + Chemotherapy for Pancreatic Cancer?
Research shows that combining nab-paclitaxel (a form of chemotherapy) with gemcitabine significantly improves survival in patients with advanced pancreatic cancer. This combination has become a standard treatment option due to its effectiveness in increasing overall and progression-free survival.12345
Is the combination of Zolbetuximab and chemotherapy safe for treating pancreatic cancer?
The combination of nab-paclitaxel (a form of chemotherapy) and gemcitabine has been shown to be generally safe for treating pancreatic cancer, with manageable side effects like neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage). These side effects were mostly mild and resolved with dose adjustments.34678
What makes the drug Zolbetuximab + Chemotherapy unique for treating pancreatic cancer?
The combination of Zolbetuximab with chemotherapy, including nab-paclitaxel and gemcitabine, is unique because nab-paclitaxel is an albumin-bound formulation that avoids the toxicities of traditional solvents and has shown improved survival rates in pancreatic cancer patients compared to gemcitabine alone. This combination leverages novel drug delivery technology to enhance treatment efficacy.257910
What is the purpose of this trial?
Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer.There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself.The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study.Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part.This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical expert panel will check the results and decide the dose to use in Part 2.Part 2 is called the Randomization Phase. People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself. The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself. In both parts of the study, zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein. This is called an infusion. Each treatment cycle is 4 weeks (28 days) long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle. People will visit the clinic on certain days during their treatment. The study doctors will check for any medical problems from zolbetuximab. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken before treatment if a previous sample is not available. People will have the option of giving a tumor sample after treatment has finished. People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
Research Team
Medical Director
Principal Investigator
Astellas Pharma Global Development
Eligibility Criteria
This trial is for adults with metastatic pancreatic adenocarcinoma that tests positive for CLDN18.2 and haven't had chemotherapy before. They should have a life expectancy of at least 12 weeks, be able to follow contraceptive guidelines, and not be pregnant or breastfeeding. People who've had certain recent treatments or surgeries, active infections, other cancers needing treatment, severe allergies to study drugs' components, or specific heart conditions can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in Phase
Participants receive one of two different doses of zolbetuximab with chemotherapy to establish the recommended dose for the next phase.
Randomization Phase
Participants are randomized to receive either zolbetuximab with chemotherapy or chemotherapy alone. Treatment cycles are 4 weeks long.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including health checks and blood tests.
Treatment Details
Interventions
- Gemcitabine
- Nab-paclitaxel
- Zolbetuximab
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
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