Study on ALE.P02 as a Single Treatment for Adults with Certain CLDN1+ Solid Tumors
Sponsor: Alentis Therapeutics AG
ClinicalTrials ID:NCT06747585
This clinical trial is testing a new drug, ALE.P02, to see if it is safe and effective for treating adults with certain types of solid tumors that are positive for Claudin-1 (CLDN1+). The study aims to find the best dose for future research.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of ALE.P02, a new drug, when used alone to treat adults with specific types of advanced or metastatic solid tumors that are positive for Claudin-1 (CLDN1+). Researchers will also determine the best dose to use in future studies.
Description
This study is divided into two phases. In Phase I, researchers will test different doses of ALE.P02 to find the safest and most effective dose for treating patients with advanced or metastatic Claudin-1 positive cancers. In Phase II, the study will focus on using the best dose found in Phase I to treat more patients and further evaluate its effectiveness.
Participants in the study will have specific types of squamous cell cancers, such as non-small cell lung cancer, head and neck cancer, esophageal cancer, or skin cancer. The study will include patients who have already tried standard treatments but did not respond well or could not tolerate them. Participants will need to provide a tissue sample for testing and meet certain health criteria to join the study.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic squamous cell cancer, such as non-small cell lung cancer, head and neck cancer, esophageal cancer, or skin cancer.
- For Phase I: Have tried at least one standard treatment and did not respond or could not tolerate it.
- For Phase II: Have tried no more than two standard treatments and did not respond or could not tolerate them.
- Provide a tissue sample for Claudin-1 testing.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have good bone marrow and organ function.
- Have recovered from any side effects of previous treatments.
- Have measurable disease based on standard criteria.
Exclusion Criteria
- Have a type of cancer that is not primarily squamous cell, such as adenosquamous carcinoma or adenocarcinoma.
- Have received cancer treatments too recently before starting the study.
- Have rapidly worsening disease, such as tumor bleeding or uncontrolled pain.
- Have uncontrolled diabetes.
- Have cancer that has spread to the brain or spinal cord.
- Have significant gastrointestinal bleeding or an active infection requiring treatment.
- Have any condition or take any medication that could interfere with the study results or participation.
- Use medications that affect heart rhythm.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.