Study of ALE.P02 Monotherapy for Adults with Advanced or Metastatic Claudin-1 Positive Squamous Solid Tumors Phase III Clinical Trial Evaluating Safety, Dosage, and Effectiveness

What this Trial Is About

Researchers are evaluating ALE.P02, a Claudin-1 targeted antibody-drug conjugate, as a monotherapy in adults with selected advanced or metastatic squamous solid tumors that express Claudin-1. This Phase III study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ALE.P02, while determining the recommended dose for Phase II treatment in patients with squamous non-small-cell lung cancer, head and neck squamous cell carcinoma, cervical squamous cell carcinoma, or esophageal squamous cell carcinoma. Participants will receive ALE.P02 through intravenous infusion. The study begins with a Phase I dose escalation to find the maximum tolerated dose and a safe recommended dose for expansion. This is followed by a Phase I dose expansion to identify the recommended Phase II dose RP2D. In Phase II, patients receive ALE.P02 at the RP2D or according to the dosing schedule determined after dose expansion. Treatment continues with monitoring to evaluate response and safety. Throughout the study, participants will undergo regular assessments including measurement of adverse events, dose-limiting toxicities, and tumor response based on RECIST 1.1 criteria. Pharmacokinetic and pharmacodynamic blood tests will be performed to track drug concentration and immune response. The study also monitors duration of response, progression-free survival, and overall survival for up to 3.5 years. Safety follow-up continues for about 30 days after the last dose, and participants are observed for long-term outcomes over several years.

A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors