Study of ALE.C04 and Pembrolizumab for Adults with Recurrent or Metastatic Head and Neck Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC). This is a condition where cancer cells form in the tissues of the head and neck and have either returned after treatment or spread to other parts of the body. The study is testing two treatments: ALE.C04, which is an experimental drug, and Pembrolizumab, a medication already used in cancer treatment. Pembrolizumab is also known by its brand name, KEYTRUDA, and works by helping the immune system fight cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of ALE.C04 both on its own and in combination with Pembrolizumab. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in phases, starting with small doses to ensure safety and gradually increasing to find the most effective dose. The study will also compare how well ALE.C04 works alone versus when combined with Pembrolizumab.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study aims to determine the best dosage for future use and to see how well the treatments work in reducing the size of the cancer or stopping its growth. This research is important for developing new treatment options for patients with R/M HNSCC.

1 initial treatment phase

The study begins with the administration of pembrolizumab and ALE.C04. Pembrolizumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The dosage and frequency will be determined by the study team based on individual needs and responses.

During this phase, the focus is on evaluating the safety and tolerability of the medications. This involves monitoring for any side effects and adjusting doses as necessary.

2 dose escalation phase

In this phase, the dosage of ALE.C04 may be gradually increased to find the most effective dose that can be tolerated without causing significant side effects.

The goal is to establish the recommended dosage for future use. This phase is crucial for understanding how the body responds to different doses of the medication.

3 combination therapy phase

Patients may receive a combination of ALE.C04 and pembrolizumab to assess the anti-tumor activity of the combination compared to pembrolizumab alone.

This phase aims to determine if the combination therapy is more effective in treating the cancer than using pembrolizumab by itself.

4 monotherapy phase

Some patients may receive ALE.C04 as a single agent to evaluate its effectiveness in treating the cancer without the addition of pembrolizumab.

The objective is to establish the recommended dosage for ALE.C04 when used alone and to assess its impact on tumor growth.

5 follow-up and monitoring

Throughout the study, regular follow-up visits are scheduled to monitor health status, side effects, and the effectiveness of the treatment.

These visits may include physical exams, blood tests, imaging studies, and other assessments as needed to ensure safety and track progress.

Who Can Join the Study?

Be willing and able to provide written consent to participate in the study. This includes a pre-screening consent and a main consent. Participation in future research is optional.
Female patients who can have children should not be breastfeeding and must use two methods of birth control, be surgically sterile, or abstain from heterosexual activity. They must also agree not to donate eggs during the study and for a period after the last dose of medication.
Male patients must agree to use contraception and not donate sperm during the study and for a period after the last dose of medication.
Patients should be able and willing to follow the study procedures and attend follow-up appointments.
Be at least 18 years old at the time of signing the consent form.
Have a confirmed diagnosis of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma that cannot be cured with local treatments. Specific requirements apply depending on the phase of the study.
Provide a tissue sample for specific tests in a certified laboratory. A new tumor sample is required at the start of the study, but an old sample may be used if a new biopsy is unsafe.
Have measurable disease based on specific criteria. Tumors in areas that were previously treated with radiation can be measured if they have shown growth.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures daily living abilities.
Show adequate organ function as defined in the study protocol. Screening tests must be done within 10 days before starting treatment.
Have results from testing for HPV status in oropharyngeal cancer using a specific test or another approved method.
Female patients who can have children must have a negative pregnancy test within 72 hours before receiving the first dose of study medication. A urine test can be used if a blood test is not suitable.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not recovered from previous treatments or surgeries.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are taking medications that could interfere with the study treatment.
Patients who have had an allergic reaction to similar treatments in the past.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse or mental health issues that could affect participation.
Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
MD Anderson Cancer Center	Madrid	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ambgsfuefe Panxuivu Hdywyopa Du Mrciqygeq	Marseille	France
Cjycxx Lrgk Balmeq	Lyon	France
Hwmvbuae Vnez dydcavuo	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2023
Italy	Not recruiting	01.12.2023
Spain	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

ALE.C04 is an experimental medication being studied for its potential to treat head and neck squamous cell carcinoma. It is an antibody that targets a protein called Claudin-1, which may be involved in the growth and spread of cancer cells. The study is exploring how safe and tolerable ALE.C04 is when used alone and in combination with another medication.

Pembrolizumab is a medication already used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, pembrolizumab is being used in combination with ALE.C04 to see if the two medications together can more effectively treat head and neck squamous cell carcinoma compared to using pembrolizumab alone.

Investigated diseases:

Squamous cell carcinoma of head and neck

Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma – This disease involves the abnormal growth of squamous cells in the head and neck region, which can recur or spread to other parts of the body. It typically begins in the mucous membranes of the mouth, nose, or throat. As the disease progresses, it may invade nearby tissues and organs, leading to symptoms such as difficulty swallowing, persistent sore throat, or changes in voice. The cancer can also metastasize, meaning it spreads to distant parts of the body, such as the lungs or bones. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.

Trial ID:

2023-505145-93-00

Protocol code:

ALE.C04.01

Trial Phase:

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

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Study of ALE.C04 and Pembrolizumab for Adults with Recurrent or Metastatic Head and Neck Cancer

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