RECRUITING

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

Conditions

Cervical Squamous Cell Carcinoma Squamous Non-small-cell Lung Cancer Colorectal Cancer Intrahepatic Cholangiocarcinoma Urothelial Carcinoma Claudin-1 Targeted Antibody-Drug Conjugate Monotherapy First-in-Human Recommended Phase 2 dose Recommended dose for expansion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Quick Facts

Study Start:2025-08-26

Study Completion:2029-10-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07169734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.
* 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.

* 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.

Contacts and Locations

Study Contact

Alentis Clinical Trial Contact

CONTACT

+41782304288

patientinfo@alentis.ch

Study Locations (Sites)

Next Oncology-Oncology

San Antonio, Texas, 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Alentis Therapeutics AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26

Study Completion Date2029-10-04

Study Record Updates

Study Start Date2025-08-26

Study Completion Date2029-10-04

Terms related to this study

Keywords Provided by Researchers

Claudin-1 Targeted Antibody-Drug Conjugate
Monotherapy
First-in-Human
Recommended Phase 2 dose
Recommended dose for expansion

Additional Relevant MeSH Terms

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