A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Recruiting · NCT07169734 · Interventional (participants receive a specific treatment) · Lead sponsor: Alentis Therapeutics AG
View the official record on ClinicalTrials.gov →Interventions studied
ALE.P03
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
- Have documented radiological disease progression at study entry.
- Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
- Phase I Dose Escalation:
- \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
- Phase I RDE and Phase II:
- Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
- Patients with actionable oncogenic drivers: received feasible targeted therapy.
- Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
- Measurable disease per RECIST 1.1, as determined by the site.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
- Demonstrate adequate bone marrow and organ function as per the protocol.
Exclusion criteria
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
- Has received antineoplastic therapies prior to study intervention within specified time frame.
- Has rapidly progressing disease.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
- Has clinically significant gastrointestinal bleeding.
- Has an active infection requiring systemic treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.
Where it is running
41 locations listed across 8 US states.
- 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
- The University of Chicago Medical Center - Oncology - Chicago, Illinois, 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
- The Netherlands Cancer Institute (NKI) - Amsterdam, Netherlands
- Hospital HM Nou Delfos - Barcelona, Spain
- Vall d'Hebron University Hospital - Barcelona, Spain
- See outside Hospital Universitario Reina Sofia - Córdoba, Spain
- Centre Georges Francois Leclerc - Oncologie Medicale - Dijon, France
- 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
- CHU La Timone - Marseille, France
- Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda - Milan, Italy
- 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
- Ravenna - Ospedale S. Maria delle Croci - Ravenna, Italy
- IRCCS Istituto Clinico Humanitas di Rozzano - Rossano, Italy
- Erasmus University Medical Center - Rotterdam, Netherlands
- Hospital universitario virgen macarena - Seville, Spain
- Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica - Siena, Italy
- National University Hospital (NUH) - Medical Oncology - Singapore, Singapore
- National Cancer Centre Singapore (NCCS) - Singapore, Singapore
- National Cheng Kung University Hospital - Tainan, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology - Taoyuan, Taiwan
- San Juan de Reus University Hospital - Tarragona, Spain
- Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) - Toulouse, France
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- La Fe University and Polytechnic Hospital - Valencia, Spain
- Institut Gustave Roussy (IGR) - Villejuif, France
- Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Hong Kong, Hong-Kong, Hong Kong