A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Start Date
12/16/2024
Completion Date
8/15/2028
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.P02 monotherapy in adult patients with selected squamous solid tumors.
Detailed Description
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 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.P02
Conditions
Locations
Mayo Foundation for Medical Education and Research - Mayo Cl
Scottsdale, Arizona 85259
United States
Providence Medical Foundation
Fullerton, California 92835
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 Institue Downtown
Louisville, Kentucky 40202
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
NEXT Oncology Virginia
Fairfax, Virginia 22031
United States
Institut Bergonie
Bordeaux, 33000
France
Centre Georges Francois Leclerc - Oncologie Medicale
Dijon, 21079
France
CHRU De Lille- Hôpital Claude Huriez - Medical Oncology
Lille, 59000
France
AP-HM Hôpital de La Timone CEPCM
Marseille, 13005
France
Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole
Toulouse, 31100
France
Institut Gustave Roussy
Villejuif, 94800
France
Chinese University of Hong Kong - Prince of Wales Hospital
Shatin, N.T.
Hong Kong
Istituto Clinico Humanitas
Milan, 20089
Italy
Ospedale San Raffaele, IRCCS
Milan, 20132
Italy
Istituto Nazionale del Tumori, Fondazione IRCCS
Milan, 20133
Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141
Italy
Ospedale Santa Maria delle Croci di Ravenna Oncologia
Ravenna, 48121
Italy
PU A. Gemelli, Universita Cattolica del Sacro Cuore
Roma,
Italy
Centro Ricerche Cliniche Verona
Verona,
Italy
National University Cancer Institue
Singapore, South West 11907
Singapore
National Cancer Centre Singapore
Singapore, South West 168583
Singapore
National Cancer Center
Goyang-si, 10408
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center - Oncology
Seoul, 5505
South Korea
START Madrid- Centro Integral Oncologico Clara Campal
PAU de Sanchinarro, Madrid 28050
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
NEXT Oncology Barcelona
Barcelona, 08023
Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035
Spain
START Hospital HM Nou Delfos
Barcelona,
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009
Spain
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
Spain
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 50006
Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 500209
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital
Taipei, 231020
Taiwan