A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Start Date
8/26/2025
Completion Date
10/4/2029
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.
Detailed Description
This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ALE.P03
ALE.P03
ALE.P03
Conditions
Locations
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona 85054
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut 06510
United States
The University of Chicago Medical Center - Oncology
Chicago, Illinois 60637
United States
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, Kentucky 40202
United States
John Theurer Cancer Center
Hackensack, New Jersey 07601
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Next Oncology-Oncology
San Antonio, Texas 78229
United States
NEXT Oncology Virginia
Fairfax, Virginia 22031
United States
Centre Georges Francois Leclerc - Oncologie Medicale
Dijon, 21000
France
CHU La Timone
Marseille, 13005
France
Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, 31100
France
Institut Gustave Roussy (IGR)
Villejuif, 94800
France
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)
Hong Kong, Hong-Kong
Hong Kong
Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
Ospedale San Raffaele, IRCCS - Oncologia Medica
Milan, 20132
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141
Italy
Ravenna - Ospedale S. Maria delle Croci
Ravenna, 48121
Italy
IRCCS Istituto Clinico Humanitas di Rozzano
Rossano, 20089
Italy
Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica
Siena, 53100
Italy
The Netherlands Cancer Institute (NKI)
Amsterdam, 1066
Netherlands
Radboudumc - Centrum voor Oncologie
Nijmegen, 6525
Netherlands
Erasmus University Medical Center
Rotterdam, 3015
Netherlands
National University Hospital (NUH) - Medical Oncology
Singapore, 119074
Singapore
National Cancer Centre Singapore (NCCS)
Singapore, 168583
Singapore
Hospital HM Nou Delfos
Barcelona, 08023
Spain
Vall d'Hebron University Hospital
Barcelona, 08035
Spain
See outside Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Virgen of Arrixaca University Clinical Hospital
El Palmar, 30120
Spain
Ramón y Cajal Hospital
Madrid, 28034
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
HM Sanchinarro University Hospital
Madrid, 28050
Spain
University Hospital Quironsalud Madrid
Madrid, 28223
Spain
Hospital universitario virgen macarena
Seville, 41009
Spain
San Juan de Reus University Hospital
Tarragona, 43204
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
La Fe University and Polytechnic Hospital
Valencia, 46026
Spain
National Cheng Kung University Hospital
Tainan, 100225
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology
Taoyuan, 33305
Taiwan