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NCT07169734 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Colorectal Cancer and Urothelial Carcinoma, sponsored by Alentis Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
180
Enrollment target
20
Study locations

NCT07169734 is a Phase 1 study of Colorectal Cancer and Urothelial Carcinoma that is actively recruiting participants, run by Alentis Therapeutics. The registered enrollment target is 180 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT07169734, a Phase 1 study of Colorectal Cancer and Urothelial Carcinoma, is actively recruiting participants, sponsored by Alentis Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
180 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.P03 monotherapy in adult patients with selected squamous solid tumors.

Conditions Studied

Colorectal Cancer Urothelial Carcinoma Intrahepatic Cholangiocarcinoma Cervical Squamous Cell Carcinoma Squamous Non-Small Cell Lung Cancer

Interventions

  • DRUG ALE.P03

Study Locations (20)

Other

  • Institut Gustave Roussy (IGR) - Villejuif
  • Ospedale San Raffaele, IRCCS - Oncologia Medica - Milan
  • Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
  • IEO - Istituto Europeo di Oncologia, IRCCS - Milan
  • Radboudumc - Centrum voor Oncologie - Nijmegen
  • National University Hospital (NUH) - Medical Oncology - Singapore
  • National Cancer Centre Singapore (NCCS) - Singapore
  • Hospital HM Nou Delfos - Barcelona
  • Vall d'Hebron University Hospital - Barcelona
  • See outside Hospital Universitario Reina Sofia - Córdoba
  • Virgen of Arrixaca University Clinical Hospital - El Palmar

Texas

  • MD Anderson Cancer Center - Houston
  • Next Oncology-Oncology - San Antonio

Arizona

  • Mayo Clinic Comprehensive Cancer Center - Phoenix

California

  • USC Norris Comprehensive Cancer Center - Los Angeles

Connecticut

  • Yale Comprehensive Cancer Center - New Haven

Kentucky

  • Norton Cancer Institute - Norton Healthcare Pavilion - Louisville

New Jersey

  • John Theurer Cancer Center - Hackensack

Virginia

  • NEXT Oncology Virginia - Fairfax

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2025-08-26
Est. Completion 2029-10-04
Phase Phase 1

Sponsor

Alentis Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07169734

The ClinicalTrials.gov registry entry for NCT07169734 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (88% lower). The listed sponsor is Alentis Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which ALE.P03 is the first listed.

NCT07169734 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT07169734 about?

NCT07169734 is a clinical study titled "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.

What is the current status of trial NCT07169734?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2025-08-26. Estimated completion is 2029-10-04.

What conditions does trial NCT07169734 study?

This clinical trial studies the following conditions: Colorectal Cancer, Urothelial Carcinoma, Intrahepatic Cholangiocarcinoma, Cervical Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT07169734?

The interventions under investigation include: ALE.P03 (DRUG).

Who is sponsoring clinical trial NCT07169734?

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

Where is trial NCT07169734 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.