RecruitingPhase 1 / Phase 2NCT07169734

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

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.

Checked against the public recordLast updated Jul 2, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1 / Phase 2
U.S. locations41
SponsorAlentis Therapeutics AG
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Alentis Therapeutics AG
Interventions being studied
Drug: ALE.P03; Drug: ALE.P03; Drug: ALE.P03
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. * Have documented radiological disease progression at study entry. * Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory. Phase I Dose Escalation: \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease. Phase I RDE and Phase II: * Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment. * Patients with actionable oncogenic drivers: received feasible targeted therapy. Applicable for Phase I Dose Escalation, Phase I RDE and Phase II: * Measurable disease per RECIST 1.1, as determined by the site. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status. * Demonstrate adequate bone marrow and organ function as per the protocol. Exclusion Criteria: * SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies. * Has clinically significant gastrointestinal bleeding. * Has an active infection requiring systemic treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic Comprehensive Cancer CenterPhoenix, Arizona
  • USC Norris Comprehensive Cancer CenterLos Angeles, California
  • Yale Comprehensive Cancer CenterNew Haven, Connecticut
  • The University of Chicago Medical Center - OncologyChicago, Illinois
  • Norton Cancer Institute - Norton Healthcare PavilionLouisville, Kentucky
  • John Theurer Cancer CenterHackensack, New Jersey
  • MD Anderson Cancer CenterHouston, Texas
  • Next Oncology-OncologySan Antonio, Texas
  • NEXT Oncology VirginiaFairfax, Virginia
  • Centre Georges Francois Leclerc - Oncologie MedicaleDijon
  • CHU La TimoneMarseille
  • Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)Toulouse

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 2, 2026. Always confirm current availability with the study team.

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