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Investigating ALE.P02 for treating specific solid tumors in adults

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors

Phase1; Phase2 Interventional Alentis Therapeutics AG · NCT06747585

This study is testing a new treatment called ALE.P02 to see if it can safely help adults with advanced solid tumors that have a specific marker called Claudin-1.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorAlentis Therapeutics AG Industry-sponsored
Locations38 sites (Scottsdale, Arizona and 37 other locations)
Trial IDNCT06747585 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of ALE.P02, a targeted antibody-drug conjugate, as a monotherapy for adult patients with advanced or metastatic Claudin-1 positive solid tumors, including various types of squamous cell carcinomas. It consists of a Phase I dose escalation to determine the recommended Phase II dose and a subsequent Phase II study to assess its anti-tumor activity. Patients will be monitored for pharmacokinetics, pharmacodynamics, and overall tolerability throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic squamous solid tumors that are Claudin-1 positive and have previously received standard treatments.

Not a fit: Patients with predominantly non-squamous histology cancers or those who have not received prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat squamous solid tumors.

How similar studies have performed: Other studies using targeted therapies for similar cancer types have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Scottsdale, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Squamous Non-small-cell Lung CancerHead and Neck Squamous Cell CarcinomaCervical Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaClaudin-1 Targeted Antibody-Drug ConjugateMonotherapyFirst-in-HumanRecommended Phase 2 dose
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.