A study testing ASP3082 in patients with advanced or spreading non-small cell lung cancer and pancreatic ductal adenocarcinoma

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What is this study about?

This study is looking at patients with two types of advanced cancer: metastatic non-small cell lung cancer and pancreatic ductal adenocarcinoma. Both of these cancers have a specific change in their genes called a KRAS G12D mutation. The treatment being tested is called ASP3082, which is given through a vein along with dextrose injection, a sugar solution used to help deliver medications. The purpose of the study is to see how well ASP3082 works against these cancers.

Patients in the study will receive ASP3082 for up to 8 weeks. During this time, doctors will check how the tumors respond to the treatment using imaging scans. The study will also involve taking samples from the tumor and blood at different times to understand how the treatment is working and why some tumors might stop responding to it. Patients with lung cancer must have already tried other standard treatments, including chemotherapy with platinum-based drugs and immunotherapy, and their cancer must have gotten worse. Patients with pancreatic cancer must have received one prior chemotherapy treatment that lasted at least 5 months before their disease progressed.

The study will measure several things to understand if the treatment is helpful. Doctors will look at whether tumors shrink or stop growing, how long any response lasts, and how long patients live without their cancer getting worse. They will also carefully track any side effects that occur during treatment. The study will examine changes in the body and in the tumor samples to learn more about how ASP3082 affects cancer cells and why some cancers might develop resistance to the treatment over time.

1 Initial assessment and confirmation

Your eligibility will be confirmed based on your diagnosis of locally advanced non-small-cell lung cancer or pancreatic ductal adenocarcinoma with a specific genetic change called KRAS G12D mutation.

Your physical condition will be assessed to ensure your performance status is adequate and your life expectancy is at least 3 months.

Blood tests and other laboratory assessments will be performed within 21 days before starting the treatment to confirm adequate bone marrow and organ function.

Your oxygen levels will be checked to ensure they are above 93 percent without supplemental oxygen.

If you are female and able to become pregnant, a pregnancy test will be performed and must be negative. You will need to use highly effective contraception methods during the study and for at least 6 months after the last dose.

If you are male, you will need to use highly effective birth control during treatment and for at least 3 months after the last dose.

2 Baseline tumor and blood sample collection

A tumor biopsy will be performed before treatment begins. This involves taking a small tissue sample from your tumor. Bone biopsies will be avoided when possible.

Blood samples will be collected for analysis.

These samples will be used to analyze specific markers that may help predict how your body responds to treatment.

3 Treatment with ASP3082

You will receive ASP3082, which is administered as an injection into your vein (intravenous injection).

The treatment is organized in cycles. Each cycle begins on day 1.

The exact dosage, frequency of administration, and duration of each cycle will be determined by the study protocol and your response to treatment.

You may also receive dextrose injection (also known as Bradex 5 percent) as an infusion into your vein. This is a glucose solution used to support the administration of the study medication.

4 Monitoring during treatment

You will have regular study visits as scheduled in the protocol to monitor your response to treatment and check for any side effects.

Your tumor size will be measured using imaging scans according to RECIST version 1.1 criteria, which is a standardized method for evaluating whether tumors are shrinking, staying the same, or growing.

A tumor biopsy will be performed while you are receiving treatment to assess how the tumor is responding.

Blood samples will be collected during treatment for ongoing analysis.

Laboratory tests will be performed regularly to monitor your blood counts and organ function.

Any side effects or adverse events will be recorded and assessed using standardized criteria.

5 End of treatment assessment

When you stop receiving the study medication, a final tumor biopsy will be performed.

Final blood samples will be collected.

Your overall response to treatment will be evaluated based on imaging scans and other assessments.

Information about any side effects you experienced will be documented.

6 Follow-up period

After completing treatment, you will be followed to assess long-term outcomes including how long any response to treatment lasts and your overall survival.

If you are female, you must continue using contraception for at least 6 months after your last dose of study medication.

If you are male, you must continue using birth control for at least 3 months after your last dose of study medication.

During this period, you must not donate eggs (if female) or sperm (if male).

Who Can Join the Study?

You must be 18 years of age or older
Your oxygen level in the blood must be greater than 93 percent when breathing normal room air without extra oxygen
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use a very reliable birth control method or not have sexual intercourse during the study and for at least 6 months after receiving the last dose of the study medicine
If you are a woman who can become pregnant, you must not donate your eggs or use your own stored eggs from the time you join the study until at least 6 months after the last dose of the study medicine
If you are a man, you must either have had surgery to prevent pregnancy, or not have sexual intercourse, or agree to use a very reliable birth control method when you join the study, during treatment, and for at least 3 months after the last dose of the study medicine
If you are a man, you must not freeze or donate sperm from the time you join the study until at least 3 months after the last dose of the study medicine
You must understand, sign, and date the informed consent form, which is a document explaining the study, before any study procedures are done, and you must be able and willing to attend all study visits and follow the study requirements
You must be part of a Social Security System or be a beneficiary of one
You must have a confirmed diagnosis through tissue examination of either locally advanced lung cancer that cannot be removed by surgery or lung cancer that has spread to other parts of the body, or pancreatic cancer that has spread, and your cancer must have a specific change in a gene called KRAS G12D mutation shown in your most recent tumor sample or blood test
If you have non-small cell lung cancer, and you do not have specific gene changes that can be treated with targeted medicines, or you have a gene change for which no approved treatment exists, you must have already received at least one prior treatment that included a platinum-based chemotherapy and a type of immunotherapy called a PD-(L)1 blocker, and your cancer must have gotten worse
If you have non-small cell lung cancer with specific gene changes such as EGFR, BRAF, MET mutations or ALK, ROS1, RET, NTRK fusions, you must have already tried all available targeted treatments for these changes and have received platinum-based chemotherapy, and your cancer must have gotten worse
If you have pancreatic cancer, you must have received only one prior line of chemotherapy for at least 5 months, and your cancer must have gotten worse
Your overall health and ability to care for yourself must be good, rated as 1 or better on a scale called ECOG performance status, which measures how the disease affects your daily living abilities
Your doctors must expect that you will live for at least 3 months
You must have at least one tumor that can be measured on imaging scans according to standard criteria called RECIST version 1.1
You must have a tumor location that can be easily reached for biopsy, which is a procedure to remove a small piece of tissue for testing, and bone biopsies should be avoided when possible. You must agree to have tumor and blood samples taken before treatment, during treatment, and at the end of treatment
Your bone marrow, which makes blood cells, and your organs such as liver and kidneys must be working well enough, based on blood tests done within 21 days before starting the study treatment

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate based on the provided information
Please note that exclusion criteria are conditions or factors that would prevent someone from joining a clinical trial, but these details are not available in the current documentation
General factors that often prevent participation in cancer studies may include having certain other medical conditions, taking specific medications, or having certain test results, but the specific requirements for this study are not provided here

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country	Status
Gfzria Hcdtkhthdyi Ucrlatpoynnhi Plskt Povbbhcklvu El Ndmeqypkujza	Paris	France
Iupvrjfi Pkxcmlcklzlqttg Cqfhrv Cohyst	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.03.2026

Trial locations

Investigated drugs:

ASP3082 is an investigational medication being studied in this trial. It is being tested to see how well it works in treating patients with certain types of cancer, specifically non-small-cell lung cancer that has spread or is locally advanced, and pancreatic ductal adenocarcinoma. This medication is still being researched and is not yet approved for general use.

Investigated diseases:

Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that has spread from the lungs to other parts of the body. Non-small cell lung cancer is the most common form of lung cancer, accounting for most cases. The disease begins when cells in the lung tissue start growing abnormally and uncontrollably. As the cancer progresses, these abnormal cells can break away and travel through the bloodstream or lymphatic system to other organs. Common sites where this cancer spreads include the bones, liver, brain, and adrenal glands. The metastatic form represents an advanced stage where the cancer is no longer confined to its original location in the lungs.

Pancreatic Ductal Adenocarcinoma – This is the most common type of pancreatic cancer, developing in the cells that line the ducts of the pancreas. The pancreas is an organ located behind the stomach that produces enzymes for digestion and hormones that regulate blood sugar. This cancer typically grows slowly at first but can be difficult to detect in early stages because it often causes no symptoms. As the disease progresses, the tumor can grow larger and may spread to nearby blood vessels, lymph nodes, and other organs. The cancer cells can eventually travel to distant parts of the body such as the liver, lungs, or the lining of the abdomen. This type of cancer develops when the cells in the pancreatic ducts undergo genetic changes that cause them to multiply uncontrollably.

Trial ID:

2025-522533-54-00

Protocol code:

CSET 2025/4116

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing ASP3082 in patients with advanced or spreading non-small cell lung cancer and pancreatic ductal adenocarcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?