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
- Amsterdam, Nijmegen, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic colorectal cancer, bile duct cancer inside the liver, squamous lung cancer, urothelial cancer or cervical squamous cell cancer who have already had standard treatments.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, or cervical squamous cell carcinoma. The disease has grown on scans. It can be measured by RECIST 1.1. Performance status (ECOG) is 0 or 1.
- Earlier treatment
- Must have had standard systemic treatment for advanced disease and not responded to it or not tolerated it. In Phase I dose escalation, this means the available standard regimens. In Phase I RDE and Phase II, 1-2 regimens. People with a treatable cancer-driving gene change must have had a feasible targeted therapy.
- Biomarker or test result
- Tumor tissue must be given for CLDN1 (Claudin-1) testing in a central laboratory.
Main reasons for not taking part
- Lung or cervical tumor that is mainly non-squamous or an adenocarcinoma
- Recent cancer treatment within the time frame set by the study
- Rapidly progressing disease
- Active brain or spinal fluid cancer spread (central nervous system metastases or carcinomatous meningitis)
- Past or current interstitial lung disease or pneumonitis needing steroids
Read by machine on 9 November 2026.
Where in Netherlands
- The Netherlands Cancer Institute (NKI)Amsterdam, NetherlandsTaking people
- Radboudumc - Centrum voor OncologieNijmegen, NetherlandsTaking people
- Erasmus University Medical CenterRotterdam, NetherlandsTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.