clinical trial · NCT07169734
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Cervical Squamous Cell CarcinomaSquamous Non-small-cell Lung CancerColorectal CancerIntrahepatic CholangiocarcinomaUrothelial CarcinomaALE.P03ALE.P03ALE.P03
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.P03 monotherapy in adult patients with selected squamous solid tumors.
started
Aug 26, 2025
primary completion
Apr 5, 2029
completion
Oct 4, 2029
last updated
Mar 19, 2026
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol