RecruitingRecruiting
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
NCT07169734 · Alentis Therapeutics AG
In plain English
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Official title
A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
About this study
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
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.
Study design
Enrollment target: 180 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-26
Estimated completion: 2029-10-04
Last updated: 2026-03-19
Interventions
Drug: ALE.P03Drug: ALE.P03Drug: ALE.P03
Primary outcomes
- • Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I) (Up to 28 days)
- • Number of Patients with Adverse Events (Phase I) (From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years]))
- • Overall Response Rate (ORR) (Phase I) (From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years))
Sponsor
Alentis Therapeutics AG · industry
Contacts & investigators
ContactAlentis Clinical Trial Contact · contact · patientinfo@alentis.ch · +41782304288
All locations (28)
Mayo Clinic Comprehensive Cancer CenterRecruiting
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Yale Comprehensive Cancer CenterRecruiting
New Haven, Connecticut, United States
Norton Cancer Institute - Norton Healthcare PavilionRecruiting
Louisville, Kentucky, United States
John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Next Oncology-OncologyRecruiting
San Antonio, Texas, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States
Institut Gustave Roussy (IGR)Recruiting
Villejuif, France
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)Recruiting
Hong Kong, Hong-Kong, Hong Kong
Ospedale San Raffaele, IRCCS - Oncologia MedicaRecruiting
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
IEO - Istituto Europeo di Oncologia, IRCCSRecruiting
Milan, Italy
Radboudumc - Centrum voor OncologieRecruiting
Nijmegen, Netherlands
National University Hospital (NUH) - Medical OncologyRecruiting
Singapore, Singapore
National Cancer Centre Singapore (NCCS)Recruiting
Singapore, Singapore
Hospital HM Nou DelfosRecruiting
Barcelona, Spain
Vall d'Hebron University HospitalRecruiting
Barcelona, Spain
See outside Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
Virgen of Arrixaca University Clinical HospitalRecruiting
El Palmar, Spain
Ramón y Cajal HospitalRecruiting
Madrid, Spain
Hospital Universitario Fundación Jiménez DíazRecruiting
Madrid, Spain
HM Sanchinarro University HospitalRecruiting
Madrid, Spain
University Hospital Quironsalud MadridRecruiting
Madrid, Spain
Hospital universitario virgen macarenaRecruiting
Seville, Spain
San Juan de Reus University HospitalRecruiting
Tarragona, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
La Fe University and Polytechnic HospitalRecruiting
Valencia, Spain