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

NCT ID NCT07169734

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma cholangiocarcinoma colorectal cancer colorectal neoplasm intrahepatic cholangiocarcinoma non-small cell squamous lung carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

CERVICAL SQUAMOUS CELL CARCINOMA COLORECTAL CANCER INTRAHEPATIC CHOLANGIOCARCINOMA SQUAMOUS NON-SMALL-CELL LUNG CANCER UROTHELIAL CARCINOMA

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

    Contact

  • HM Sanchinarro University Hospital

    RECRUITING

    Madrid, 28050, Spain

    Contact

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

    Contact

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

    Contact

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

    Contact

  • Hospital universitario virgen macarena

    RECRUITING

    Seville, 41009, Spain

    Contact

  • IEO - Istituto Europeo di Oncologia, IRCCS

    RECRUITING

    Milan, 20141, Italy

    Contact

  • Institut Gustave Roussy (IGR)

    RECRUITING

    Villejuif, 94800, France

    Contact

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

    Contact

  • La Fe University and Polytechnic Hospital

    RECRUITING

    Valencia, 46026, Spain

    Contact

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

    Contact

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

    Contact

  • National Cancer Centre Singapore (NCCS)

    RECRUITING

    Singapore, 168583, Singapore

    Contact

  • National University Hospital (NUH) - Medical Oncology

    RECRUITING

    Singapore, 119074, Singapore

    Contact

  • Next Oncology-Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact

  • Norton Cancer Institute - Norton Healthcare Pavilion

    RECRUITING

    Louisville, Kentucky, 40202, United States

    Contact

  • Ospedale San Raffaele, IRCCS - Oncologia Medica

    RECRUITING

    Milan, 20132, Italy

    Contact

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

    RECRUITING

    Hong Kong, Hong-Kong, Hong Kong

    Contact

  • Radboudumc - Centrum voor Oncologie

    RECRUITING

    Nijmegen, 6525, Netherlands

    Contact

  • Ramón y Cajal Hospital

    RECRUITING

    Madrid, 28034, Spain

    Contact

  • San Juan de Reus University Hospital

    RECRUITING

    Tarragona, 43204, Spain

    Contact

  • See outside Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

    Contact

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

    Contact

  • University Hospital Quironsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

    Contact

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

    Contact

  • Virgen of Arrixaca University Clinical Hospital

    RECRUITING

    El Palmar, 30120, Spain

    Contact

  • Yale Comprehensive Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

    Contact