Investigating ALE.P02 for treating specific solid tumors in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have disease and treatment history as: 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 Monotherapy 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.
* Phase I Combination Therapy RDE: Have received no previous systemic therapy in incurable recurrent or metastatic setting
* 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 it's running

• Mayo Foundation for Medical Education and Research - Mayo Cl
  Scottsdale, Arizona, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• The University of Chicago Medical Center - Oncology
  Chicago, Illinois, United States Recruiting
• Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• NEXT Oncology Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Alentis Clinical Trial Contact
• Email: patientinfo@alentis.ch
• Phone: +41782304288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.