RecruitingPhase 1Phase 2NCT06747585

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

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors

Sponsor

Alentis Therapeutics AG

Enrollment

170 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma Squamous Non-small-cell Lung Cancer Cervical Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called ALE.P02 in people with certain advanced solid tumors that have a protein called CLDN1 on their surface. The tumors included are squamous non-small cell lung cancer, head and neck cancers, esophageal squamous cell cancer, and cutaneous squamous cell cancer. **You may be eligible if...** - You have been diagnosed with advanced, inoperable, or metastatic squamous lung cancer, head and neck cancer (including nasopharyngeal), esophageal squamous cell cancer, or skin squamous cell cancer - Your tumor has been tested and is CLDN1-positive - You have already received standard treatments and they have stopped working or caused intolerable side effects - You are in reasonably good general health (performance status 0 or 1) - Your liver, kidneys, and bone marrow are functioning adequately **You may NOT be eligible if...** - Your tumor does not have the CLDN1 protein - You have not yet tried standard treatment options - You have received more than 2 prior lines of treatment (for some phases of the study) - Your general health or organ function is too poor to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALE.P02

ALE.P02, will be administered by IV infusion according to the assigned arms.

Locations(38)

Mayo Foundation for Medical Education and Research - Mayo Cl

Scottsdale, Arizona, United States

Providence Medical Foundation

Fullerton, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

The University of Chicago Medical Center - Oncology

Chicago, Illinois, United States

Norton Cancer Institue Downtown

Louisville, Kentucky, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Institut Bergonie

Bordeaux, France

Centre Georges Francois Leclerc - Oncologie Medicale

Dijon, France

CHRU De Lille- Hôpital Claude Huriez - Medical Oncology

Lille, France

AP-HM Hôpital de La Timone CEPCM

Marseille, France

Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Chinese University of Hong Kong - Prince of Wales Hospital

Shatin, N.T., Hong Kong

Ospedale San Raffaele, IRCCS

Milan, Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, Italy

Ospedale Santa Maria delle Croci di Ravenna Oncologia

Ravenna, Italy

PU A. Gemelli, Universita Cattolica del Sacro Cuore

Roma, Italy

Centro Ricerche Cliniche Verona

Verona, Italy

National University Cancer Institue

Singapore, South West, Singapore

National Cancer Centre Singapore

Singapore, South West, Singapore

National Cancer Center

Goyang-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

START Madrid- Centro Integral Oncologico Clara Campal

PAU de Sanchinarro, Madrid, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

NEXT Oncology Barcelona

Barcelona, Spain

Hospital Universitari Vall D Hebron

Barcelona, Spain

START Hospital HM Nou Delfos

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen De La Victoria

Málaga, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Spain

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Taiwan

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06747585

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