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

NCT ID NCT07169734

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 180 people

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

Started

Aug 2025

Expected to finish

Oct 2029

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 histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. * Have documented radiological disease progression at study entry. * Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory. Phase I Dose Escalation: \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease. Phase I RDE and Phase II: * Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment. * Patients with actionable oncogenic drivers: received feasible targeted therapy. Applicable for Phase I Dose Escalation, Phase I RDE and Phase II: * Measurable disease per RECIST 1.1, as determined by the site. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status. * Demonstrate adequate bone marrow and organ function as per the protocol. Exclusion Criteria: * SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies. * Has clinically significant gastrointestinal bleeding. * Has an active infection requiring systemic treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

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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

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

  • 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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