Recruiting

Study of ALE.

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study is looking at people who have advanced or metastatic solid tumors, which means cancer that has spread or cannot be removed by surgery. The specific types of cancer being studied include colorectal cancer, a type of bile duct cancer called intrahepatic cholangiocarcinoma, a type of lung cancer called squamous non-small cell lung cancer, urothelial carcinoma which affects the bladder and urinary tract, and cervical squamous cell carcinoma. All of these cancers must have a specific protein called CLDN1 present in the tumor cells. The treatment being tested is called ALE.P03, which is an antibody-drug conjugate that targets the Claudin-1 protein. This medication is given through a needle into a vein, which is called intravenous infusion, and is provided as a powder that is mixed into a solution before being given to patients.

The purpose of this study is to test the safety of ALE.P03 and find the right dose to use, and then to see how well it works against these types of cancer. The study is divided into two main parts called Phase 1 and Phase 2. In Phase 1, different doses of the medication will be tested in small groups of patients to see which dose is safest and best tolerated. During this part, doctors will carefully watch for any side effects and check how the body handles the medication. In Phase 2, the chosen dose will be given to a larger group of patients to see how well the medication works at shrinking or controlling the cancer.

Patients joining this study must have already received standard treatments for their cancer, which may have included chemotherapy, certain antibodies that help the immune system fight cancer, and other medications depending on the type of cancer. The study requires a sample of tumor tissue to be tested in a laboratory to confirm that the CLDN1 protein is present at high enough levels. During the study, patients will have regular check-ups that include blood tests, physical examinations, heart monitoring using ECG, and scans to measure the size of the tumors. The doctors will track any side effects, measure how much medication is in the blood over time, and check whether the body develops an immune response to the medication. The study will continue until 2029.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and testing
Your tissue sample will be analyzed in a central laboratory to check the level of a protein called CLDN1 in your tumor cells. This sample should be collected within 180 days before joining the study, unless taking a new sample would be unsafe for you. If a new sample cannot be obtained, an older tissue sample may be used, preferably collected before your most recent cancer treatment started.
You will undergo screening tests within 14 days before receiving the first dose of the study medication. These tests will check your blood counts, liver function, kidney function, and other organ systems to ensure your body can handle the treatment.
Your tumor will be measured using imaging scans to establish a baseline according to RECIST 1.1, which is a standard method for measuring tumors in clinical studies.
Your overall health and ability to carry out daily activities will be assessed using the ECOG performance status scale, which ranges from 0 to 5, with lower numbers indicating better function.
If you are a woman of childbearing potential, you will have a pregnancy test within 72 hours before receiving the first dose of the study medication.
An electrocardiogram (a test that records the electrical activity of your heart) will be performed, and your vital signs will be measured.
Step 2
Receiving the study medication
You will receive ALE.P03, which is the study medication being tested. This medication is an antibody-drug conjugate that targets the CLDN1 protein on tumor cells.
The medication will be given to you through an intravenous infusion, which means it will be delivered directly into your vein through a needle or catheter.
The medication comes as a powder for solution for infusion, which will be prepared by the study staff before being given to you.
The dose you receive will depend on which phase of the study you are in. During Phase I, different doses are being tested to find the safest and most effective dose. During Phase II, you will receive the dose that was determined to be most appropriate in Phase I.
The frequency and duration of your infusions will be determined by the study protocol and the phase you are participating in. Your treatment will continue in cycles, with specific intervals between doses.
Step 3
Regular monitoring during treatment
Throughout your participation, you will be monitored closely for any side effects or adverse events. This includes both mild and serious adverse events that may occur.
Blood samples will be taken regularly to check your blood counts, liver function, kidney function, and other laboratory values to ensure the medication is not causing harmful changes in your body.
Your vital signs, such as blood pressure, heart rate, and temperature, will be measured at each visit.
Electrocardiograms will be performed periodically to monitor your heart function.
Blood samples will be collected to measure the level of ALE.P03 in your bloodstream. This helps determine how your body processes the medication. Specific measurements include how much medication is in your blood at different times and how long it stays in your system.
Blood samples will also be taken to check if your body develops antibodies against the study medication, which is called immunogenicity testing.
Step 4
Tumor response assessment
At regular intervals during the study, you will have imaging scans to measure your tumor and see how it is responding to the treatment.
The response of your tumor will be evaluated using RECIST 1.1 criteria, which is a standardized way to determine if the tumor has shrunk, stayed the same size, or grown.
The study will track several outcomes, including the objective response rate (the percentage of patients whose tumors shrink significantly), duration of response (how long the tumor shrinkage lasts), and disease control rate (the percentage of patients whose disease does not get worse).
Your progression-free survival will be measured, which is the length of time during and after treatment that your disease does not get worse.
Your overall survival will also be tracked throughout the study and follow-up period.
Step 5
Treatment continuation or modification
Your treatment may be interrupted or the dose may be adjusted if you experience certain side effects. The study will track these dose interruptions and changes in dose intensity.
You will continue receiving the study medication as long as your disease is not getting worse and you are not experiencing unacceptable side effects.
If you are in Phase I of the study, the study team will be carefully watching for dose-limiting toxicities, which are serious side effects that occur at a specific dose level and help determine the safest dose to use.
Step 6
Contraception requirements during treatment
If you are a woman of childbearing potential, you must use two methods of birth control throughout the study and for 180 days after receiving your last dose of the study medication.
If you are a male patient, you must use an adequate method of contraception and not donate sperm starting from your first dose through 90 days after your last dose of the study medication.
Step 7
End of treatment and follow-up
After you stop receiving the study medication, you will continue to be monitored for side effects and long-term outcomes.
Follow-up assessments will continue to track your survival and disease status.
The study is expected to continue until approximately September 2029, though your individual participation length may vary depending on how your disease responds to treatment and whether you experience side effects.

Who can join the trial?

13 criteria

You must be willing and able to provide written informed consent, which means signing a document showing you understand and agree to join the study
You must be at least 18 years of age or older when you sign the consent form
You must have advanced or metastatic cancer that has been confirmed by tissue examination under a microscope. This means cancer that has spread beyond where it started or cannot be removed by surgery. The cancer types include colorectal cancer (cancer of the colon or rectum), intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver), squamous non-small cell lung cancer (a specific type of lung cancer), urothelial carcinoma (cancer of the bladder or urinary tract lining), or cervical squamous cell carcinoma (a type of cervical cancer)
Your cancer must be getting worse as shown by imaging scans at the time you join the study
Your tumor must have a specific protein called CLDN1 at certain levels, which will be tested by a laboratory. The required level depends on which part of the study you join
You must have already received standard cancer treatments that are available for your type of cancer, and your cancer has either continued to grow during these treatments or you could not tolerate them. The number and types of treatments required depend on your cancer type and which part of the study you join
You must provide a sample of your tumor tissue for testing. This should ideally be collected within 180 days (about 6 months) before joining the study, unless taking a new sample would be unsafe for you
You must have at least one tumor that can be measured on imaging scans
You must have a performance status of 0 or 1 on the ECOG scale, which means you are able to carry out normal activities or have only minor symptoms that do not prevent you from doing light work
Your blood tests must show that your bone marrow (the part of your body that makes blood cells), liver, and kidneys are working well enough. These tests must be done within 14 days before starting the study treatment
If you are a female who can become pregnant, you must have a negative pregnancy test within 72 hours before receiving the first dose of study treatment
If you are a female who can become pregnant, you must agree to use two methods of birth control or avoid sexual activity from the start of the study until 180 days (about 6 months) after your last dose of study treatment
If you are a male patient, you must agree to use adequate birth control methods and not donate sperm from the start of the study until 90 days (about 3 months) after your last dose of study treatment

Who cannot join the trial?

5 criteria

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial
Exclusion criteria typically include things like certain other medical conditions, previous treatments, laboratory test results, or medications that would make it unsafe or inappropriate for someone to join the study
The study involves patients with advanced or metastatic solid tumors, meaning cancers that have grown large or spread to other parts of the body
To learn the specific reasons why you might not be able to participate, you would need access to the complete study documentation

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Verified sites

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Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

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Investigated drugs

ALE.P03 is an experimental medication being tested in this clinical trial. It is an antibody-drug conjugate, which means it combines an antibody (a protein that can find specific targets in the body) with a cancer-fighting drug. This medication is designed to target a protein called Claudin-1 that is found on certain cancer cells. By attaching to this protein, ALE.P03 can deliver the cancer-fighting drug directly to the tumor cells, which may help destroy them while limiting damage to healthy cells. This medication is being studied as a treatment for adults with advanced or metastatic solid tumors that have the Claudin-1 protein.

ALE.P03

What is already known about the treatment

ALE.P03 – ALE.P03 is an experimental antibody-drug conjugate that specifically targets a protein called Claudin-1, which is found on the surface of certain cancer cells. This medication is currently being studied in early-phase clinical trials (Phase I/II) to test its safety and effectiveness in adult patients with advanced or metastatic solid tumors that express the Claudin-1 protein. The drug works by binding to Claudin-1 on cancer cells and delivering a toxic substance directly into these cells to destroy them, while limiting damage to healthy tissues. It is administered as a monotherapy, meaning it is given alone without combination with other cancer treatments, and researchers are working to determine the appropriate dose and evaluate its ability to shrink tumors.

Investigated diseases

Advanced or Metastatic Solid Tumors – This condition refers to solid cancers that have either grown extensively in their original location (advanced) or spread from their primary site to other parts of the body (metastatic). Solid tumors are abnormal masses of tissue that do not contain liquid-filled areas or cysts, and can develop in various organs and tissues throughout the body. When tumors become advanced, they have typically grown larger and may have invaded nearby tissues or structures. Metastatic tumors occur when cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in distant organs. This represents a later stage of cancer development where the disease has progressed beyond its initial location. The progression involves continuous growth and potential spread to multiple body sites over time.