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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
• Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
• Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
• Have provided tissue for CLDN1 analysis in a central laboratory.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
• Demonstrate adequate bone marrow and organ function.
• Patients must have recovered from all toxicities led by prior treatment.
• Have measurable disease based on RECIST 1.1 as determined by the site.
Locations
United States
Arizona
Mayo Foundation for Medical Education and Research - Mayo Cl
RECRUITING
Scottsdale
California
Providence Medical Foundation
RECRUITING
Fullerton
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Connecticut
Yale Comprehensive Cancer Center
RECRUITING
New Haven
Illinois
The University of Chicago Medical Center - Oncology
RECRUITING
Chicago
Kentucky
Norton Cancer Institue Downtown
RECRUITING
Louisville
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Other Locations
France
Institut Gustave Roussy
RECRUITING
Villejuif
Hong Kong Special Administrative Region
Chinese University of Hong Kong - Prince of Wales Hospital
RECRUITING
Shatin
Italy
IEO - Istituto Europeo di Oncologia, IRCCS
RECRUITING
Milan
Ospedale San Raffaele, IRCCS
RECRUITING
Milan
Ospedale Santa Maria delle Croci di Ravenna Oncologia
RECRUITING
Ravenna
PU A. Gemelli, Universita Cattolica del Sacro Cuore
RECRUITING
Roma
Centro Ricerche Cliniche Verona
RECRUITING
Verona
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Cancer Institue
RECRUITING
Singapore
Spain
Hospital Universitari Vall D Hebron
RECRUITING
Barcelona
START Hospital HM Nou Delfos
RECRUITING
Barcelona
Hospital Universitario Virgen De La Victoria
RECRUITING
Málaga
START Madrid- Centro Integral Oncologico Clara Campal
RECRUITING
Pau De Sanchinarro
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario Y Politécnico La Fe
RECRUITING
Valencia
Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
RECRUITING
Changhua
Changhua Christian Medical Foundation Changhua Christian Hospital
RECRUITING
Changhua
Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Alentis Clinical Trial Contact
patientinfo@alentis.ch
+41782304288
Time Frame
Start Date:2024-12-16
Estimated Completion Date:2028-08-15
Participants
Target number of participants:170
Treatments
Experimental: Phase I Dose Escalation- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Phase I dose escalation part of the study.
Experimental: Phase I Dose Expansion- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study to identify Recommended Phase II Dose (RP2D) for Phase II.
Experimental: Phase II- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.