RecruitingInterventionalPhase 1Phase 2Last updated Jun 29, 2026

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

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors

Overview

ClinicalTrials.gov ID: NCT06747585
Lead Sponsor: Alentis Therapeutics AGINDUSTRY
Brief 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.P02 monotherapy in adult patients with selected squamous solid tumors.
Study Type: Interventional

Status

Overall Status: Recruiting
Start Date: Dec 16, 2024Actual
Primary Completion Date: Feb 15, 2028Estimated
Completion Date: Aug 15, 2028Estimated

Study Record Dates

First Submitted: Dec 17, 2024
First Submitted that Met QC Criteria: Dec 20, 2024
First Posted: Dec 24, 2024Actual
Last Update Submitted that Met QC Criteria: Jun 26, 2026
Last Update Posted: Jun 29, 2026Actual
Last Verified: Jun 2026

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