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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

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
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Abpfauilzm Pagceyqz Hphvnwzm Dg Mrnyucwgk	Marseille	France
Hkbevidb Vkdd dpafcuhd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.04.2025
Italy	Recruiting	02.04.2025
Spain	Recruiting	02.04.2025

Trial locations

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.

Investigated diseases:

Neoplasm

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.

Trial ID:

2024-515459-39-00

Protocol code:

ALE.P02.01

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

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