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NCT06747585 · ClinicalTrials.gov registry record · Phase 1

A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma, sponsored by Alentis Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
170
Enrollment target
20
Study locations

NCT06747585 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma that is actively recruiting participants, run by Alentis Therapeutics. The registered enrollment target is 170 participants, above the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT06747585, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Alentis Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
170 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG ALE.P02

Study Locations (20)

Other

  • Institut Bergonie - Bordeaux
  • Centre Georges Francois Leclerc - Oncologie Medicale - Dijon
  • CHRU De Lille- Hôpital Claude Huriez - Medical Oncology - Lille
  • AP-HM Hôpital de La Timone CEPCM - Marseille
  • Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole - Toulouse
  • Institut Gustave Roussy - Villejuif
  • Ospedale San Raffaele, IRCCS - Milan
  • IEO - Istituto Europeo di Oncologia, IRCCS - Milan
  • Ospedale Santa Maria delle Croci di Ravenna Oncologia - Ravenna
  • PU A. Gemelli, Universita Cattolica del Sacro Cuore - Roma
  • Centro Ricerche Cliniche Verona - Verona

California

  • Providence Medical Foundation - Fullerton
  • USC Norris Comprehensive Cancer Center - Los Angeles

Arizona

  • Mayo Foundation for Medical Education and Research - Mayo Cl - Scottsdale

Connecticut

  • Yale Comprehensive Cancer Center - New Haven

Illinois

  • The University of Chicago Medical Center - Oncology - Chicago

Kentucky

  • Norton Cancer Institue Downtown - Louisville

New Jersey

  • Hackensack University Medical Center - Hackensack

Virginia

  • NEXT Oncology Virginia - Fairfax

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2024-12-16
Est. Completion 2028-08-15
Phase Phase 1

Sponsor

Alentis Therapeutics

4 total trials

What the Registry Record Tells You About NCT06747585

The ClinicalTrials.gov registry entry for NCT06747585 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (47% higher). The listed sponsor is Alentis Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which ALE.P02 is the first listed.

NCT06747585 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06747585 about?

NCT06747585 is a clinical study titled "A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected 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.P02 monotherapy in adult patients with selected squamous solid tumors.

What is the current status of trial NCT06747585?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2024-12-16. Estimated completion is 2028-08-15.

What conditions does trial NCT06747585 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT06747585?

The interventions under investigation include: ALE.P02 (DRUG).

Who is sponsoring clinical trial NCT06747585?

This trial is sponsored by Alentis Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06747585 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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