New Antibody-Drug conjugate takes aim at Hard-to-Treat cancers

NCT ID NCT07169734

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new drug called ALE.P03 in adults with advanced or metastatic solid tumors that have a specific protein (Claudin-1) on their surface. The drug is an antibody-drug conjugate designed to deliver a toxic payload directly to cancer cells. The trial has two phases: Phase 1 finds the safest dose, and Phase 2 checks if the drug shrinks tumors. About 180 participants with certain cancers (cervical, lung, colorectal, bile duct, or bladder) are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
ALE.P03 (a Claudin-1 targeted antibody-drug conjugate)
What this could lead to
If successful, this could lead to a new treatment option for several advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHU La Timone

    RECRUITING

    Marseille, 13005, France

  • Centre Georges Francois Leclerc - Oncologie Medicale

    RECRUITING

    Dijon, 21000, France

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

    RECRUITING

    Toulouse, 31100, France

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, 3015, Netherlands

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • HM Sanchinarro University Hospital

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital universitario virgen macarena

    RECRUITING

    Seville, 41009, Spain

  • IEO - Istituto Europeo di Oncologia, IRCCS

    RECRUITING

    Milan, 20141, Italy

  • IRCCS Istituto Clinico Humanitas di Rozzano

    RECRUITING

    Rossano, 20089, Italy

  • Institut Gustave Roussy (IGR)

    RECRUITING

    Villejuif, 94800, France

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • La Fe University and Polytechnic Hospital

    RECRUITING

    Valencia, 46026, Spain

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Cancer Centre Singapore (NCCS)

    RECRUITING

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 100225, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • National University Hospital (NUH) - Medical Oncology

    RECRUITING

    Singapore, 119074, Singapore

  • Next Oncology-Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Norton Cancer Institute - Norton Healthcare Pavilion

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Ospedale San Raffaele, IRCCS - Oncologia Medica

    RECRUITING

    Milan, 20132, Italy

  • Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica

    RECRUITING

    Siena, 53100, Italy

  • Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)

    RECRUITING

    Hong Kong, Hong-Kong, Hong Kong

  • Radboudumc - Centrum voor Oncologie

    RECRUITING

    Nijmegen, 6525, Netherlands

  • Ramón y Cajal Hospital

    RECRUITING

    Madrid, 28034, Spain

  • Ravenna - Ospedale S. Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • San Juan de Reus University Hospital

    RECRUITING

    Tarragona, 43204, Spain

  • See outside Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • The Netherlands Cancer Institute (NKI)

    RECRUITING

    Amsterdam, 1066, Netherlands

  • 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

  • University Hospital Quironsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

  • Virgen of Arrixaca University Clinical Hospital

    RECRUITING

    El Palmar, 30120, Spain

  • Yale Comprehensive Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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