clinical trial · NCT06747585
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung CancerHead and Neck Squamous Cell CarcinomaCervical Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaALE.P02
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.
started
Dec 16, 2024
primary completion
Feb 15, 2028
completion
Aug 15, 2028
last updated
Mar 3, 2026
detailed description
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 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.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol