OncoMatch/Clinical Trials/NCT06747585
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Is NCT06747585 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ALE.P02 for squamous non-small-cell lung cancer.
Treatment: ALE.P02 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Biomarker criteria
Required: CLDN1 expression
provided tissue for CLDN1 analysis in a central laboratory
Disease stage
Metastatic disease required
advanced locally recurrent and inoperable or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic standard of care regimen
Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment
Cannot have received: antineoplastic therapies within specified time frame
Has received antineoplastic therapies prior to study intervention within specified time frame
Lab requirements
Blood counts
adequate bone marrow
Kidney function
Liver function
Demonstrate adequate bone marrow and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Foundation for Medical Education and Research - Mayo Cl · Scottsdale, Arizona
- Providence Medical Foundation · Fullerton, California
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Yale Comprehensive Cancer Center · New Haven, Connecticut
- The University of Chicago Medical Center - Oncology · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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