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A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected 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.P02 monotherapy in adult patients with selected squamous solid tumors.
Official title: A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2024-12-16
Completion Date
2028-08-15
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
ALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.
Locations (38)
Mayo Foundation for Medical Education and Research - Mayo Cl
Scottsdale, Arizona, United States
Providence Medical Foundation
Fullerton, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
The University of Chicago Medical Center - Oncology
Chicago, Illinois, United States
Norton Cancer Institue Downtown
Louisville, Kentucky, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Institut Bergonie
Bordeaux, France
Centre Georges Francois Leclerc - Oncologie Medicale
Dijon, France
CHRU De Lille- Hôpital Claude Huriez - Medical Oncology
Lille, France
AP-HM Hôpital de La Timone CEPCM
Marseille, France
Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Chinese University of Hong Kong - Prince of Wales Hospital
Shatin, N.T., Hong Kong
Ospedale San Raffaele, IRCCS
Milan, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy
Ospedale Santa Maria delle Croci di Ravenna Oncologia
Ravenna, Italy
PU A. Gemelli, Universita Cattolica del Sacro Cuore
Roma, Italy
Centro Ricerche Cliniche Verona
Verona, Italy
National University Cancer Institue
Singapore, South West, Singapore
National Cancer Centre Singapore
Singapore, South West, Singapore
National Cancer Center
Goyang-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
START Madrid- Centro Integral Oncologico Clara Campal
PAU de Sanchinarro, Madrid, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
NEXT Oncology Barcelona
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
START Hospital HM Nou Delfos
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen De La Victoria
Málaga, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Universitario Y Politécnico La Fe
Valencia, Spain
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital
Taipei, Taiwan