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New drug ALE.P02 targets tough cancers in early trial

NCT ID NCT06747585

Disease control Sponsor: Alentis Therapeutics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests a new drug called ALE.P02 in people with advanced squamous cell cancers of the lung, head and neck, cervix, or esophagus that have spread or cannot be removed. The goal is to find the safest and most effective dose and see if it can shrink tumors. About 170 adults will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC. * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * Have provided tissue for CLDN1 analysis in a central laboratory. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. * Demonstrate adequate bone marrow and organ function. * Patients must have recovered from all toxicities led by prior treatment. * Have measurable disease based on RECIST 1.1 as determined by the site. Exclusion Criteria: * Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain). * Patients with uncontrolled diabetes. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate. * Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma non-small cell squamous lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical squamous cell carcinoma Esophageal squamous cell carcinoma Head and neck squamous cell carcinoma Squamous non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    41 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AP-HM Hôpital de La Timone CEPCM

    RECRUITING

    Marseille, 13005, France

  • Asan Medical Center - Oncology

    RECRUITING

    Seoul, 5505, South Korea

  • Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital

    RECRUITING

    Taipei, 231020, Taiwan

  • CHRU De Lille- Hôpital Claude Huriez - Medical Oncology

    RECRUITING

    Lille, 59000, France

  • Centre Georges Francois Leclerc - Oncologie Medicale

    RECRUITING

    Dijon, 21079, France

  • Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole

    RECRUITING

    Toulouse, 31100, France

  • Centro Ricerche Cliniche Verona

    RECRUITING

    Verona, Italy

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    RECRUITING

    Changhua, 50006, Taiwan

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    RECRUITING

    Changhua, 500209, Taiwan

  • Chinese University of Hong Kong - Prince of Wales Hospital

    RECRUITING

    Shatin, N.T., Hong Kong

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital Universitari Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Quironsalud Madrid

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen De La Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen De La Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • IEO - Istituto Europeo di Oncologia, IRCCS

    RECRUITING

    Milan, 20141, Italy

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Istituto Clinico Humanitas

    RECRUITING

    Milan, 20089, Italy

  • Istituto Nazionale del Tumori, Fondazione IRCCS

    RECRUITING

    Milan, 20133, Italy

  • Mayo Foundation for Medical Education and Research - Mayo Cl

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • NEXT Oncology Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Cancer Center

    RECRUITING

    Goyang-si, 10408, South Korea

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, South West, 168583, Singapore

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • National University Cancer Institue

    RECRUITING

    Singapore, South West, 11907, Singapore

  • Norton Cancer Institue Downtown

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Ospedale San Raffaele, IRCCS

    RECRUITING

    Milan, 20132, Italy

  • Ospedale Santa Maria delle Croci di Ravenna Oncologia

    RECRUITING

    Ravenna, 48121, Italy

  • PU A. Gemelli, Universita Cattolica del Sacro Cuore

    RECRUITING

    Roma, Italy

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • START Hospital HM Nou Delfos

    RECRUITING

    Barcelona, Spain

  • START Madrid- Centro Integral Oncologico Clara Campal

    RECRUITING

    PAU de Sanchinarro, Madrid, 28050, Spain

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • The University of Chicago Medical Center - Oncology

    RECRUITING

    Chicago, Illinois, 60637, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Yale Comprehensive Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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