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Study on the Safety and Effectiveness of Mitazalimab with Chemotherapy for Patients with Metastatic Pancreatic Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic pancreatic ductal adenocarcinoma. This is a form of pancreatic cancer that has spread to other parts of the body. The study is testing a new treatment that combines a medication called mitazalimab with various chemotherapy drugs. Mitazalimab, also known by its code name ADC-1013, is a type of protein designed to help the immune system fight cancer. The chemotherapy drugs used in this study include calcium folinate, irinotecan hydrochloride, paclitaxel, levoleucovorin disodium, folinic acid, fluorouracil, gemcitabine hydrochloride, and oxaliplatin. These drugs are commonly used to treat various types of cancer and work by stopping the growth of cancer cells.

The purpose of this study is to determine the best dose of mitazalimab when used with chemotherapy and to assess how well this combination works against the cancer. The study is divided into different parts. In the first part, researchers will find the most suitable dose of mitazalimab to use in further testing. In the later parts, they will evaluate how effective the treatment is in shrinking the cancer or stopping it from growing. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study aims to provide valuable information on the safety and effectiveness of mitazalimab combined with chemotherapy for treating metastatic pancreatic ductal adenocarcinoma. This research could potentially lead to new treatment options for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient provides written informed consent and undergoes initial screening to confirm eligibility.
Eligibility includes being 18 years or older, having a diagnosis of metastatic pancreatic ductal adenocarcinoma, and meeting specific health criteria.
Step 2
Treatment phase 1
The first phase involves determining the recommended dose of mitazalimab in combination with chemotherapy.
Medications administered include calcium folinate, irinotecan, paclitaxel, levoleucovorin disodium, fluorouracil, gemcitabine hydrochloride, and oxaliplatin, all given intravenously.
The specific dosage and frequency are adjusted based on the patient's response and tolerance.
Step 3
Treatment phase 2 and 3
In these phases, the focus is on assessing the clinical activity of mitazalimab with chemotherapy.
The objective is to evaluate the anti-tumor effects using established guidelines.
The same medications from phase 1 continue to be used, with adjustments as necessary.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring of health status and response to treatment is conducted.
This includes tracking any side effects and adjusting treatment as needed.
The trial aims to measure outcomes such as response rate, disease control, and overall survival.
Step 5
Completion of the trial
The trial is estimated to conclude by January 31, 2026.
Upon completion, final assessments are made to evaluate the effectiveness and safety of the treatment.

Who can join the trial?

19 criteria

The patient must have given written permission to participate in the study.
The patient must be at least 18 years old when agreeing to join the study.
The patient should be able to perform daily activities with little or no help, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, with a score of 0 or 1.
The patient must have a confirmed diagnosis of a type of cancer called metastatic pancreatic ductal adenocarcinoma that has not been treated before.
The patient must have a disease that can be measured using specific guidelines called RECIST v. 1.1.
The patient must not have received chemotherapy for pancreatic ductal adenocarcinoma before.
The patient must not have had radiation treatment to the abdomen, except for pain relief in areas not being measured in the study.
The patient must be expected to live for at least 3 more months.
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The patient must have acceptable blood test results, including:
- Enough neutrophils (a type of white blood cell) without recent medication to increase them.
- Enough platelets (cells that help with blood clotting).
- Enough hemoglobin (a protein in red blood cells that carries oxygen), which can be after a blood transfusion.
- check
  The patient must have acceptable results from other blood tests, including:
  - Bilirubin levels within a certain range (biliary drainage is allowed).
  - AST and ALT levels within a certain range, regardless of liver spread.
  - Creatinine levels within a certain range or a specific kidney function level called glomerular filtration rate (GFR).
  - INR (a measure of blood clotting) within a certain range.
  - Albumin levels within a certain range.
  - Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for at least six months after.
  - Men who can father children must agree to use effective birth control during the study and for at least six months after.
  - The patient must be willing to follow all the procedures required by the study.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides metastatic pancreatic ductal adenocarcinoma cannot participate. This means the cancer has spread from the pancreas to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are not specified but could include serious health issues.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
Patients who have allergies or reactions to the study medication or similar drugs cannot participate.
Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Grand Hopital De Charleroi
Charleroi, Belgium

Trial locations

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Investigated drugs

Mitazalimab is an investigational medication being studied for its potential to enhance the effects of chemotherapy in treating metastatic pancreatic ductal adenocarcinoma. It is being tested to determine the best dose for further studies and to evaluate its ability to help shrink or control tumors when used alongside standard chemotherapy treatments.

What is already known about the treatment

Mitazalimab – Mitazalimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating metastatic pancreatic ductal adenocarcinoma. It is in the investigational stage, with ongoing research assessing its safety and effectiveness when combined with chemotherapy. The main therapeutic indication is for patients with advanced pancreatic cancer. Mitazalimab works by targeting specific proteins on cancer cells, enhancing the immune system's ability to attack and destroy these cells. It is classified as an immunotherapy agent, focusing on boosting the body's natural defenses to fight cancer.

Investigated diseases

Metastatic pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can invade nearby tissues and organs. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to distant sites, forming new tumors. Symptoms may include abdominal pain, weight loss, and jaundice, although they often appear only after the cancer has advanced. The progression of the disease can vary, but it typically involves increasing tumor size and spread to other organs.