RecruitingPhase 1Phase 2NCT07169734

A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Sponsor

Alentis Therapeutics AG

Enrollment

180 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Squamous Non-small-cell Lung Cancer Cervical Squamous Cell Carcinoma

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 trial is testing a new drug called ALE.P03 that targets a protein called Claudin-1 (CLDN1) found on certain cancer cells. It is being studied in people with advanced or metastatic solid tumors including colorectal cancer, bile duct cancer (intrahepatic cholangiocarcinoma), squamous lung cancer, bladder cancer, and cervical squamous cell cancer. **You may be eligible if...** - You have an advanced or metastatic tumor of one of the five cancer types listed above - Your tumor has been confirmed by biopsy and tested for CLDN1 expression - Your cancer has continued to grow despite prior standard treatments - You have received 1 to 2 prior lines of systemic therapy (for Phase 2) - You are in adequate overall health **You may NOT be eligible if...** - Your cancer does not express the Claudin-1 protein - You have had more than 2 prior lines of treatment (for Phase 2) - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active brain metastases requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

DRUGALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

DRUGALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

Locations(28)

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Norton Cancer Institute - Norton Healthcare Pavilion

Louisville, Kentucky, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

MD Anderson Cancer Center

Houston, Texas, United States

Next Oncology-Oncology

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Institut Gustave Roussy (IGR)

Villejuif, France

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

Hong Kong, Hong-Kong, Hong Kong

Ospedale San Raffaele, IRCCS - Oncologia Medica

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, Italy

Radboudumc - Centrum voor Oncologie

Nijmegen, Netherlands

National University Hospital (NUH) - Medical Oncology

Singapore, Singapore

National Cancer Centre Singapore (NCCS)

Singapore, Singapore

Hospital HM Nou Delfos

Barcelona, Spain

Vall d'Hebron University Hospital

Barcelona, Spain

See outside Hospital Universitario Reina Sofia

Córdoba, Spain

Virgen of Arrixaca University Clinical Hospital

El Palmar, Spain

Ramón y Cajal Hospital

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

HM Sanchinarro University Hospital

Madrid, Spain

University Hospital Quironsalud Madrid

Madrid, Spain

Hospital universitario virgen macarena

Seville, Spain

San Juan de Reus University Hospital

Tarragona, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

La Fe University and Polytechnic Hospital

Valencia, Spain

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NCT07169734

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