A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell 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.P02 monotherapy in adult patients with selected squamous solid tumors.

Key facts

Study ID

NCT06747585

Run by

Alentis Therapeutics AG

People needed

170

Starts

2024-12-16

Expected to finish

2028-08-15

Last updated by the study team

2026-06-29

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
• Has received antineoplastic therapies prior to study intervention within specified time frame.
• Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
• Patients with uncontrolled diabetes.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
• Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.

Where it is running

• Mayo Foundation for Medical Education and Research - Mayo Cl — Scottsdale, Arizona, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, 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 Institue Downtown — Louisville, Kentucky, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)
• Institut Bergonie — Bordeaux, France (enrolling)
• Centre Georges Francois Leclerc - Oncologie Medicale — Dijon, France (enrolling)
• CHRU De Lille- Hôpital Claude Huriez - Medical Oncology — Lille, France (enrolling)
• AP-HM Hôpital de La Timone CEPCM — Marseille, France (enrolling)
• Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole — Toulouse, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• Chinese University of Hong Kong - Prince of Wales Hospital — Shatin, N.T., Hong Kong (enrolling)
• Istituto Clinico Humanitas — Milan, Italy (enrolling)
• Ospedale San Raffaele, IRCCS — Milan, Italy (enrolling)
• Istituto Nazionale del Tumori, Fondazione IRCCS — Milan, Italy (enrolling)
• IEO - Istituto Europeo di Oncologia, IRCCS — Milan, Italy (enrolling)
• Ospedale Santa Maria delle Croci di Ravenna Oncologia — Ravenna, Italy (enrolling)
• PU A. Gemelli, Universita Cattolica del Sacro Cuore — Roma, Italy (enrolling)
• Centro Ricerche Cliniche Verona — Verona, Italy (enrolling)
• National University Cancer Institue — Singapore, South West, Singapore (enrolling)
• National Cancer Centre Singapore — Singapore, South West, Singapore (enrolling)
• National Cancer Center — Goyang-si, South Korea (enrolling)

Full record on ClinicalTrials.gov

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