Phase III Study of ALE.P03 Intravenous Monotherapy in Adults With Advanced or Metastatic Claudin-1 Positive Solid Tumors

What this Trial Is About

Researchers are evaluating ALE.P03 monotherapy in adults with selected advanced or metastatic Claudin-1 positive CLDN1 solid tumors, including colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. The study includes Phase I dose escalation to determine the maximum tolerated dose and recommended dose for expansion, followed by Phase II to assess the recommended Phase II dose. The purpose is to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ALE.P03. Participants will receive ALE.P03 through intravenous infusion. In Phase I dose escalation, the dose is gradually increased until the maximum tolerated dose or a safe recommended dose is identified. In Phase I dose expansion, patients receive the safe recommended dose to confirm the recommended Phase II dose. In Phase II, participants receive ALE.P03 at the recommended Phase II dose or according to the dosing schedule after the expansion phase. Throughout the study, patients will undergo assessments including monitoring for dose limiting toxicities, adverse events, overall and duration of response, disease control rate, and survival outcomes up to four years. Blood samples will be collected for detailed pharmacokinetic and antibody analyses from treatment initiation until the end of treatment. Safety follow-up occurs up to 30 days after the last dose, with long-term monitoring extending up to four years. The study evaluates both clinical outcomes and biological measures to understand the effects of ALE.P03.

A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors