Clinical Trial

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

Recruiting Phase 1/2
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Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.
Protocol Amendment History 1 change
notable Trial sites expanded: 28 -> 41 locations 2026-07-03
Trial Details
NCT Number NCT07169734
Lead Sponsor Alentis Therapeutics AG
Conditions Cervical Squamous Cell Carcinoma, Squamous Non-small-cell Lung Cancer, Colorectal Cancer, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
Enrollment 180 participants
Start Date 2025-08-26
Primary Completion 2029-04-05 (estimated)
Study Completion 2029-10-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-02