Study on ALE.P03 as a Single Treatment for Adults with Certain Advanced or Metastatic CLDN1+ Solid Tumors
Sponsor: Alentis Therapeutics AG
ClinicalTrials ID:NCT07169734
This clinical trial is testing a new drug, ALE.P03, to see if it is safe and effective for treating adults with certain advanced or metastatic solid tumors that are positive for Claudin-1 (CLDN1).
Patient Parameters
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Program Overview
The aim of this study is to evaluate the safety and effectiveness of ALE.P03 when used alone in treating adults with specific types of advanced or metastatic solid tumors that test 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.P03 to find the safest and most effective dose for treating advanced or metastatic cancers that are positive for Claudin-1 (CLDN1). In Phase II, the study will focus on using the best dose found in Phase I to treat these cancers.
Participants in the study will have advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, or cervical squamous cell carcinoma. They must have shown disease progression and provided a tissue sample for Claudin-1 analysis. The study will assess how well ALE.P03 works on its own and monitor any side effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, or cervical squamous cell carcinoma.
- Have evidence of disease progression at the start of the study.
- Provide a tissue sample for Claudin-1 (CLDN1) analysis.
Phase I Dose Escalation:
- Have tried and not responded to or cannot tolerate standard treatments for advanced disease.
Phase I RDE and Phase II:
- Have tried 1-2 standard treatments for advanced disease and not responded or cannot tolerate them.
- If applicable, have received targeted therapy for specific genetic changes in the cancer.
Applicable for all phases:
- Have measurable disease according to standard criteria.
- Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate bone marrow and organ function as per the study protocol.
Exclusion Criteria
- Have squamous non-small cell lung cancer or cervical squamous cell carcinoma with a tumor that is mostly non-squamous or adenocarcinoma.
- Have received cancer treatments too close to the start of the study.
- Have rapidly progressing disease.
- Have active cancer spread to the brain or spinal cord.
- Have a history of lung disease that required steroids or currently have significant lung issues needing treatment.
- Have significant gastrointestinal bleeding.
- Have an active infection needing treatment.
- Have any condition or treatment that could interfere with the study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Next Oncology-Oncology | 78229 | San Antonio | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
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