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A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Sponsor: Alentis Therapeutics AG
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
Conditions
Interventions
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
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