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RECRUITING
NCT07169734
PHASE1/PHASE2

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

Sponsor: Alentis Therapeutics AG

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-08-26

Completion Date

2029-10-04

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

ALE.P03

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

DRUG

ALE.P03

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

DRUG

ALE.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