Tests ALE.P03 in adults with advanced CLDN1-positive solid tumors
Tests the ALE.P03 drug alone in adults with certain advanced cancers that carry CLDN1.
Plain-language title generated from the registry record
Registry title: A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Key facts
- Where
- Barcelona, Córdoba, El Palmar, Madrid, Seville, Tarragona, and Valencia, SpainSee the 12 sites
- Phase
- Phase 1/2
Where in Spain
- Hospital HM Nou DelfosBarcelona, SpainTaking people
- Vall d'Hebron University HospitalBarcelona, SpainTaking people
- See outside Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Virgen of Arrixaca University Clinical HospitalEl Palmar, SpainTaking people
- HM Sanchinarro University HospitalMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Ramón y Cajal HospitalMadrid, SpainTaking people
- University Hospital Quironsalud MadridMadrid, SpainTaking people
- Hospital Universitario Virgen MacarenaSeville, SpainTaking people
- San Juan de Reus University HospitalTarragona, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- La Fe University and Polytechnic HospitalValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alentis Therapeutics AG
- Trial code
- NCT07169734EU 2025-521441-24-00
- Record updated
- 2 July 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: Has received antineoplastic therapies prior to study intervention within specified time frame; Has rapidly progressing disease; 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; SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma; Has known active central nervous system metastases and/or carcinomatous meningitis.