A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Cervical Squamous Cell Carcinoma, Squamous Non-small-cell Lung Cancer, Colorectal Cancer, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07169734

Run by

Alentis Therapeutics AG

People needed

180

Starts

2025-08-26

Expected to finish

2029-10-04

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Mayo Clinic Comprehensive Cancer Center — Phoenix, Arizona, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Yale Comprehensive Cancer Center — New Haven, Connecticut, United States (enrolling)
• The University of Chicago Medical Center - Oncology — Chicago, Illinois, United States (enrolling)
• Norton Cancer Institute - Norton Healthcare Pavilion — Louisville, Kentucky, United States (enrolling)
• John Theurer Cancer Center — Hackensack, New Jersey, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Next Oncology-Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)
• Centre Georges Francois Leclerc - Oncologie Medicale — Dijon, France (enrolling)
• CHU La Timone — Marseille, France (enrolling)
• Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) — Toulouse, France (enrolling)
• Institut Gustave Roussy (IGR) — Villejuif, France (enrolling)
• Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) — Hong Kong, Hong-Kong, Hong Kong (enrolling)
• Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
• Ospedale San Raffaele, IRCCS - Oncologia Medica — Milan, Italy (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (enrolling)
• IEO - Istituto Europeo di Oncologia, IRCCS — Milan, Italy (enrolling)
• Ravenna - Ospedale S. Maria delle Croci — Ravenna, Italy (enrolling)
• IRCCS Istituto Clinico Humanitas di Rozzano — Rossano, Italy (enrolling)
• Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica — Siena, Italy (enrolling)
• The Netherlands Cancer Institute (NKI) — Amsterdam, Netherlands (enrolling)
• Radboudumc - Centrum voor Oncologie — Nijmegen, Netherlands (enrolling)
• Erasmus University Medical Center — Rotterdam, Netherlands (enrolling)
• National University Hospital (NUH) - Medical Oncology — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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