OncoMatch/Clinical Trials/NCT07169734
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Is NCT07169734 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ALE.P03 and ALE.P03 for cervical squamous cell carcinoma.
Treatment: ALE.P03 · ALE.P03 · ALE.P03 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Cholangiocarcinoma
Urothelial Carcinoma
Biomarker criteria
Required: CLDN1 expression
provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory
Disease stage
Metastatic disease required
metastatic confirmed advanced or metastatic... Measurable disease per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic standard of care regimen — advanced disease
Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment
Must have received: targeted therapy — advanced disease
Patients with actionable oncogenic drivers: received feasible targeted therapy
Cannot have received: antineoplastic therapies
Exception: within specified time frame
Has received antineoplastic therapies prior to study intervention within specified time frame
Lab requirements
Blood counts
adequate bone marrow function as per the protocol
Kidney function
adequate organ function as per the protocol
Liver function
adequate organ function as per the protocol
Demonstrate adequate bone marrow and organ function as per the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Comprehensive Cancer Center · Phoenix, Arizona
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Yale Comprehensive Cancer Center · New Haven, Connecticut
- Norton Cancer Institute - Norton Healthcare Pavilion · Louisville, Kentucky
- John Theurer Cancer Center · Hackensack, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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