Study on ALE.C04 for Patients with Head and Neck Cancer

Sponsor: Alentis Therapeutics AG

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06054477

Provider View

This clinical trial is testing a new treatment called ALE.C04, both on its own and combined with another drug, pembrolizumab, to see if it is safe and effective for patients with head and neck cancer.

Patient Parameters

Program Overview

The study aims to find out if ALE.C04, a new treatment, is safe and effective for patients with head and neck cancer. It will be tested alone and in combination with pembrolizumab, a drug already used in cancer treatment. Researchers will also determine the best dose for future studies and evaluate how well the combination works against tumors.

Description

The study is divided into two phases. In Phase I, researchers will test different doses of ALE.C04, both alone and with pembrolizumab, to find the safest and most effective dose. In Phase II, patients will be randomly assigned to receive either the combination of ALE.C04 and pembrolizumab or pembrolizumab alone, to compare the effectiveness of the treatments.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of head and neck squamous cell carcinoma that cannot be cured with local treatments.
  • Provide a tissue sample for specific biomarker analysis.
  • Have measurable cancer as determined by standard criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have results from HPV testing for oropharyngeal cancer.

Exclusion Criteria

  • Have cancer that has progressed within 6 months after completing treatment for advanced head and neck cancer (for Phase II combination part only).
  • Have had radiation or other non-systemic therapy within 2 weeks before starting the study, unless fully recovered from any side effects.
  • Have had severe immune-related side effects from previous immune-oncology treatments (for Phase I and Phase II monotherapy).
  • Have active cancer spread to the brain or spinal cord.
  • Have skin conditions requiring active treatment, such as psoriasis or eczema.
  • Have any condition or treatment that might interfere with the study or not be in the patient's best interest, according to the doctor.
  • Have previously received certain immune-oncology treatments (for Phase II combination part only).

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