A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 29, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Alentis Therapeutics AG
- Interventions being studied
- Drug: ALE.P02
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Foundation for Medical Education and Research - Mayo ClScottsdale, Arizona
- Providence Medical FoundationFullerton, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Yale Comprehensive Cancer CenterNew Haven, Connecticut
- The University of Chicago Medical Center - OncologyChicago, Illinois
- Norton Cancer Institue DowntownLouisville, Kentucky
- Hackensack University Medical CenterHackensack, New Jersey
- NEXT Oncology VirginiaFairfax, Virginia
- Institut BergonieBordeaux
- Centre Georges Francois Leclerc - Oncologie MedicaleDijon
- CHRU De Lille- Hôpital Claude Huriez - Medical OncologyLille
- AP-HM Hôpital de La Timone CEPCMMarseille
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2026. Always confirm current availability with the study team.