AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma

Doctors are running a study for adults with pancreatic cancer that has spread and has a specific genetic change called KRAS G12D. The study is testing a new drug, ASP3082, alongside standard chemotherapy (mFOLFIRINOX or NALIRIFOX). We want to find out if this new combination helps people live longer and improves their quality of life compared to standard treatment alone. Half the participants will get the new drug plus chemotherapy, and the other half will get a dummy medicine (placebo) plus chemotherapy. This is to carefully compare the effects of the new drug. Safety and side effects will also be closely monitored throughout the study.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Astellas Pharma Global Development Inc.

Enrolment target

Start

10 Jun 2026

Adult participants with metastatic PDAC with KRAS G12D mutation

What is this study about?

This important study is for adults who have pancreatic cancer that has spread to other parts of the body (this is called metastatic pancreatic adenocarcinoma). Specifically, it's for people whose cancer has a particular genetic feature known as a KRAS G12D mutation. This mutation is like a specific instruction in the cancer cells that tells them to grow, and treatments are being developed to target it.

The main goal of this study is to see if adding a new medicine, called ASP3082, to the usual chemotherapy treatment (either mFOLFIRINOX or NALIRIFOX) helps people live longer. This new combination will be compared to receiving the usual chemotherapy combined with a 'dummy' medicine (placebo). By doing this comparison, doctors can determine if ASP3082 is effective.

We will also be looking at other important things, like how long people live without their cancer growing worse, how well the treatment shrinks the cancer, and how it affects their daily lives and overall quality of life. Understanding how the treatment makes people feel and any side effects it might cause is a very important part of finding new and better medicines.

Key takeaways

This study is for advanced pancreatic cancer with a specific genetic change (KRAS G12D mutation).
It tests a new drug (ASP3082) combined with standard chemotherapy.
The main goal is to see if the new medicine helps people live longer.
It's a 'double-blind' study, meaning you won't know if you're getting the new drug or a placebo.
Your health and quality of life will be carefully monitored.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. Both men and women are welcome to take part.

Crucially, you must have pancreatic cancer that has spread to other parts of your body. Your doctors will also need to confirm that your cancer has a specific genetic change called a KRAS G12D mutation. This is a special type of testing that they can do.

There will also be other medical checks and criteria that your doctor will need to review to make sure this study is safe and appropriate for you. For example, they will check your general health, how well your organs are working, and if you have any other serious medical conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with pancreatic cancer that has spread?
Has your doctor confirmed your cancer has the KRAS G12D genetic mutation?
Are you able to undertake chemotherapy treatments as advised by your doctor?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will likely have regular hospital visits for treatments and check-ups. You'll receive either the new drug ASP3082 or a dummy medicine, in combination with standard chemotherapy, through an infusion (drip). During these visits, the study team will carry out various tests, including blood tests, physical exams, and scans, to monitor your health and how the treatment is working. You'll also be asked to complete questionnaires about your quality of life.

The treatment period will continue as long as it is safe and beneficial for you, or until your cancer progresses. Even after you stop receiving the study treatment, you will have follow-up appointments to check on your long-term health. The total time you spend involved in the study – from the start of treatment to the end of follow-up – will be discussed with you by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to a new treatment before it's widely available. However, new treatments can have side effects, and some might be serious or unexpected. The study team will explain all known risks and carefully monitor your health throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is a 'KRAS G12D mutation'?

It's a specific genetic change found in some cancer cells that tells them to grow. This study is for people whose pancreatic cancer has this particular change.

What is 'standard treatment'?

In this study, standard treatment refers to chemotherapy regimens called mFOLFIRINOX or NALIRIFOX, which are common treatments for pancreatic cancer.

What does 'double-blind' mean?

It means neither you nor your doctors will know if you're receiving the new medicine or the dummy medicine. This helps ensure the study results are fair and unbiased.

Will I get better if I join this study?

We hope the new treatment will be effective, but there's no guarantee. This study is designed to find out if it is. Your doctors will discuss your individual situation.

How long will I be in the study?

The time you spend on treatment and follow-up will vary depending on how the treatment works for you. The study team will explain the expected duration.