NCT07169734

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

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Alentis Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.

Conditions

• Cervical Squamous Cell Carcinoma
• Squamous Non-small-cell Lung Cancer
• Colorectal Cancer
• Intrahepatic Cholangiocarcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	ALE.P03	ALE.P03, will be administered by IV infusion according to the assigned arms.
DRUG	ALE.P03	ALE.P03, will be administered by IV infusion according to the assigned arms.
DRUG	ALE.P03	ALE.P03, will be administered by IV infusion according to the assigned arms.

Timeline

• Start date: 2025-08-26
• Primary completion: 2029-04-05
• Completion: 2029-10-04
• First posted: 2025-09-12
• Last updated: 2026-03-19

Locations

28 sites across 7 countries: United States, France, Hong Kong, Italy, Netherlands, Singapore, Spain

Regulatory

• FDA-regulated drug study