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NCT07169734PHASE1, PHASE2Recruiting

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

Alentis Therapeutics AG

Start Date

8/26/2025

Completion Date

10/4/2029

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.

Detailed Description

This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 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 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.

Interventions

DRUG

ALE.P03

DRUG

ALE.P03

DRUG

ALE.P03

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Conditions

Cervical Squamous Cell CarcinomaSquamous Non-small-cell Lung CancerColorectal CancerIntrahepatic CholangiocarcinomaUrothelial Carcinoma

Locations

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona 85054

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 Institute - Norton Healthcare Pavilion

Louisville, Kentucky 40202

United States

John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Next Oncology-Oncology

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

Centre Georges Francois Leclerc - Oncologie Medicale

Dijon, 21000

France

CHU La Timone

Marseille, 13005

France

Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

Toulouse, 31100

France

Institut Gustave Roussy (IGR)

Villejuif, 94800

France

Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)

Hong Kong, Hong-Kong

Hong Kong

Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Ospedale San Raffaele, IRCCS - Oncologia Medica

Milan, 20132

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, 20141

Italy

Ravenna - Ospedale S. Maria delle Croci

Ravenna, 48121

Italy

IRCCS Istituto Clinico Humanitas di Rozzano

Rossano, 20089

Italy

Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica

Siena, 53100

Italy

The Netherlands Cancer Institute (NKI)

Amsterdam, 1066

Netherlands

Radboudumc - Centrum voor Oncologie

Nijmegen, 6525

Netherlands

Erasmus University Medical Center

Rotterdam, 3015

Netherlands

National University Hospital (NUH) - Medical Oncology

Singapore, 119074

Singapore

National Cancer Centre Singapore (NCCS)

Singapore, 168583

Singapore

Hospital HM Nou Delfos

Barcelona, 08023

Spain

Vall d'Hebron University Hospital

Barcelona, 08035

Spain

See outside Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Virgen of Arrixaca University Clinical Hospital

El Palmar, 30120

Spain

Ramón y Cajal Hospital

Madrid, 28034

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

HM Sanchinarro University Hospital

Madrid, 28050

Spain

University Hospital Quironsalud Madrid

Madrid, 28223

Spain

Hospital universitario virgen macarena

Seville, 41009

Spain

San Juan de Reus University Hospital

Tarragona, 43204

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

La Fe University and Polytechnic Hospital

Valencia, 46026

Spain

National Cheng Kung University Hospital

Tainan, 100225

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology

Taoyuan, 33305

Taiwan