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NCT06747585PHASE1, PHASE2Recruiting

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

Alentis Therapeutics AG

Start Date

12/16/2024

Completion Date

8/15/2028

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.

Detailed Description

This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC. * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * Have provided tissue for CLDN1 analysis in a central laboratory. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. * Demonstrate adequate bone marrow and organ function. * Patients must have recovered from all toxicities led by prior treatment. * Have measurable disease based on RECIST 1.1 as determined by the site. Exclusion Criteria: * Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain). * Patients with uncontrolled diabetes. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate. * Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.

Interventions

DRUG

ALE.P02

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Conditions

Squamous Non-small-cell Lung CancerHead and Neck Squamous Cell CarcinomaCervical Squamous Cell CarcinomaEsophageal Squamous Cell Carcinoma

Locations

Mayo Foundation for Medical Education and Research - Mayo Cl

Scottsdale, Arizona 85259

United States

Providence Medical Foundation

Fullerton, California 92835

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Yale Comprehensive Cancer Center

New Haven, Connecticut 06510

United States

The University of Chicago Medical Center - Oncology

Chicago, Illinois 60637

United States

Norton Cancer Institue Downtown

Louisville, Kentucky 40202

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

Institut Bergonie

Bordeaux, 33000

France

Centre Georges Francois Leclerc - Oncologie Medicale

Dijon, 21079

France

CHRU De Lille- Hôpital Claude Huriez - Medical Oncology

Lille, 59000

France

AP-HM Hôpital de La Timone CEPCM

Marseille, 13005

France

Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole

Toulouse, 31100

France

Institut Gustave Roussy

Villejuif, 94800

France

Chinese University of Hong Kong - Prince of Wales Hospital

Shatin, N.T.

Hong Kong

Istituto Clinico Humanitas

Milan, 20089

Italy

Ospedale San Raffaele, IRCCS

Milan, 20132

Italy

Istituto Nazionale del Tumori, Fondazione IRCCS

Milan, 20133

Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, 20141

Italy

Ospedale Santa Maria delle Croci di Ravenna Oncologia

Ravenna, 48121

Italy

PU A. Gemelli, Universita Cattolica del Sacro Cuore

Roma,

Italy

Centro Ricerche Cliniche Verona

Verona,

Italy

National University Cancer Institue

Singapore, South West 11907

Singapore

National Cancer Centre Singapore

Singapore, South West 168583

Singapore

National Cancer Center

Goyang-si, 10408

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center - Oncology

Seoul, 5505

South Korea

START Madrid- Centro Integral Oncologico Clara Campal

PAU de Sanchinarro, Madrid 28050

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

NEXT Oncology Barcelona

Barcelona, 08023

Spain

Hospital Universitari Vall D Hebron

Barcelona, 08035

Spain

START Hospital HM Nou Delfos

Barcelona,

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Virgen De La Victoria

Málaga, 29010

Spain

Hospital Universitario Virgen De La Macarena

Seville, 41009

Spain

Hospital Universitario Y Politécnico La Fe

Valencia, 46026

Spain

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 50006

Taiwan

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 500209

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital

Taipei, 231020

Taiwan