Recruiting

Study of ALE.P02 for Adults with Advanced or Metastatic Squamous Solid Tumors

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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 certain types of advanced or metastatic cancers known as squamous solid tumors. These are cancers that have spread or are difficult to remove surgically. The study is testing a new treatment called ALE.P02, which is a type of medicine known as an antibody-drug conjugate. This treatment is designed to target a specific protein called Claudin-1 that is found on the surface of some cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of ALE.P02 when used alone in adult patients with these specific types of tumors. The study will be conducted in two phases. In the first phase, the focus will be on determining the safest dose of the treatment. In the second phase, the study will assess how well the treatment works against the cancer. Participants will receive the treatment through an intravenous infusion, which means the medicine will be given directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study aims to gather information on how the treatment affects the cancer and the overall health of the participants. This information will help researchers understand the potential benefits and risks of using ALE.P02 for treating these types of cancers.

The research process

The trial runs in 6 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, you will be required to provide written informed consent. This means you agree to participate in the study after understanding all the details and potential risks involved.
Step 2
Initial assessments
You will undergo initial assessments to ensure you meet the study's eligibility criteria. This includes a review of your medical history and a series of tests to check your overall health and the status of your condition.
A fresh tumor tissue sample will be collected for CLDN1 analysis. If a recent sample is not available, an older sample may be used if a new biopsy is deemed unsafe.
Step 3
Treatment phase
You will receive the study medication, ALE.P02, which is a targeted therapy administered through an intravenous infusion. The dosage and frequency will be determined based on the phase of the trial you are participating in.
The treatment will continue as per the study protocol, and you will be monitored closely for any side effects or changes in your condition.
Step 4
Regular monitoring
Throughout the study, you will have regular visits to the study center for monitoring. This includes physical exams, blood tests, and imaging studies to assess the response of your condition to the treatment.
Your vital signs and laboratory values will be checked to ensure your safety and to monitor the effects of the treatment.
Step 5
End of treatment
At the end of the treatment phase, you will undergo a final set of assessments to evaluate the overall impact of the study medication on your condition.
You will be asked to continue using contraception for 180 days after the last dose of the study medication to prevent pregnancy.
Step 6
Follow-up
After completing the treatment, you will have follow-up visits to monitor your health and any long-term effects of the study medication.
These visits will help gather information on the duration of response and overall survival rates.

Who can join the trial?

10 criteria

Be voluntarily willing and able to provide written informed consent for the clinical study.
Must have recovered from all side effects caused by previous treatments, except for those not considered a safety risk like hair loss or skin color changes.
Female patients who can have children must have a negative pregnancy test before starting the study and agree to use two methods of birth control or be surgically sterile or abstain from heterosexual activity during the study and for 180 days after the last dose. Male patients must agree to use contraception and not donate sperm during the study and for 180 days after the last dose.
Should be willing and able to follow all study requirements.
Must be at least 18 years old on the day of signing the consent form.
Have a confirmed diagnosis of advanced or metastatic squamous solid tumors, such as certain types of lung, head and neck, esophageal, or skin cancers, and have received specific prior treatments as outlined in the study.
Must provide a tissue sample for analysis, preferably a fresh sample taken within 180 days before starting the study. If a fresh sample cannot be taken due to safety concerns, an older sample may be used.
Have measurable disease based on specific criteria, meaning the cancer can be measured and tracked during the study.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Demonstrate adequate bone marrow and organ function, with specific laboratory values required before starting the study.

Who cannot join the trial?

8 criteria

Patients with other types of cancer that are not advanced or metastatic squamous solid tumors cannot participate.
Patients who have not recovered from previous cancer treatments or surgeries are excluded.
Patients with severe heart problems or uncontrolled high blood pressure cannot join the study.
Patients with active infections, including HIV or hepatitis, are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients who are currently participating in another clinical trial are not eligible.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

ALE.P02 is a special type of treatment called an antibody-drug conjugate. This means it combines two parts: an antibody and a drug. The antibody is designed to find and attach to a specific protein called Claudin-1, which is found on certain cancer cells. Once the antibody attaches to the cancer cell, the drug part of ALE.P02 is released to help kill the cancer cell. This treatment is being tested to see if it is safe and how well it works in people with certain advanced or spreading cancers that have this protein.

What is already known about the treatment

ALE.P02 – ALE.P02 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating advanced or metastatic squamous solid tumors, which are a type of cancer. The medication works by targeting a protein called Claudin-1 on the surface of cancer cells, delivering a toxic substance directly to these cells to kill them. This approach is known as an antibody-drug conjugate, which combines an antibody with a drug to specifically attack cancer cells while minimizing damage to normal cells.

Investigated diseases

Advanced or Metastatic Squamous Solid Tumors – These tumors originate from squamous cells, which are flat cells found on the surface of the skin and lining of various organs. As the disease progresses, the tumors can grow and invade nearby tissues. In advanced stages, the cancer cells may spread to other parts of the body, a process known as metastasis. This spread can affect organs such as the lungs, liver, or bones. The progression of the disease can lead to the formation of new tumors in these distant sites. The behavior and growth rate of these tumors can vary depending on their location and the individual characteristics of the cancer cells.