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
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Study contacts
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Contact
Email: •••••@•••••
Locations
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CHU La Timone
RECRUITINGMarseille, 13005, France
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Centre Georges Francois Leclerc - Oncologie Medicale
RECRUITINGDijon, 21000, France
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Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
RECRUITINGToulouse, 31100, France
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Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology
RECRUITINGTaoyuan, 33305, Taiwan
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Erasmus University Medical Center
RECRUITINGRotterdam, 3015, Netherlands
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Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITINGMilan, 20133, Italy
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HM Sanchinarro University Hospital
RECRUITINGMadrid, 28050, Spain
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Hospital Clinico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital HM Nou Delfos
RECRUITINGBarcelona, 08023, Spain
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Hospital Universitario Fundación Jiménez Díaz
RECRUITINGMadrid, 28040, Spain
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Hospital universitario virgen macarena
RECRUITINGSeville, 41009, Spain
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IEO - Istituto Europeo di Oncologia, IRCCS
RECRUITINGMilan, 20141, Italy
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IRCCS Istituto Clinico Humanitas di Rozzano
RECRUITINGRossano, 20089, Italy
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Institut Gustave Roussy (IGR)
RECRUITINGVillejuif, 94800, France
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John Theurer Cancer Center
RECRUITINGHackensack, New Jersey, 07601, United States
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La Fe University and Polytechnic Hospital
RECRUITINGValencia, 46026, Spain
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Mayo Clinic Comprehensive Cancer Center
RECRUITINGPhoenix, Arizona, 85054, United States
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NEXT Oncology Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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National Cancer Centre Singapore (NCCS)
RECRUITINGSingapore, 168583, Singapore
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National Cheng Kung University Hospital
RECRUITINGTainan, 100225, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, 100225, Taiwan
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National University Hospital (NUH) - Medical Oncology
RECRUITINGSingapore, 119074, Singapore
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Next Oncology-Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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Norton Cancer Institute - Norton Healthcare Pavilion
RECRUITINGLouisville, Kentucky, 40202, United States
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Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda
RECRUITINGMilan, 20162, Italy
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Ospedale San Raffaele, IRCCS - Oncologia Medica
RECRUITINGMilan, 20132, Italy
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Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica
RECRUITINGSiena, 53100, Italy
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Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)
RECRUITINGHong Kong, Hong-Kong, Hong Kong
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Radboudumc - Centrum voor Oncologie
RECRUITINGNijmegen, 6525, Netherlands
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Ramón y Cajal Hospital
RECRUITINGMadrid, 28034, Spain
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Ravenna - Ospedale S. Maria delle Croci
RECRUITINGRavenna, 48121, Italy
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San Juan de Reus University Hospital
RECRUITINGTarragona, 43204, Spain
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See outside Hospital Universitario Reina Sofia
RECRUITINGCórdoba, 14004, Spain
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The Netherlands Cancer Institute (NKI)
RECRUITINGAmsterdam, 1066, Netherlands
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The University of Chicago Medical Center - Oncology
RECRUITINGChicago, Illinois, 60637, United States
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USC Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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University Hospital Quironsalud Madrid
RECRUITINGMadrid, 28223, Spain
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Vall d'Hebron University Hospital
RECRUITINGBarcelona, 08035, Spain
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Virgen of Arrixaca University Clinical Hospital
RECRUITINGEl Palmar, 30120, Spain
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Yale Comprehensive Cancer Center
RECRUITINGNew Haven, Connecticut, 06510, United States
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