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Taking people in TaiwanPhase 1/2

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.

Key facts

Who runs it
Alentis Therapeutics AG
Where
Tainan, Taipei, and Taoyuan, TaiwanSee the 3 sitesAlso in 7 other countries, 38 sites
Registry title
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
180 people, planned
Started
26 Aug 2025
Expected to end
4 Oct 2029
Type of study
Interventional, 3 groups
Treatments tested
  • ALE.P03
Record updated
2 July 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Taiwan

Also in 7 other countries, 38 sites

  • National Cheng Kung University HospitalTainan, TaiwanContact: Principal InvestigatorTaking people
  • National Taiwan University HospitalTaipei, TaiwanContact: Principal InvestigatorTaking people
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - OncologyTaoyuan, TaiwanContact: Principal InvestigatorTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Phase I Dose Escalation- ALE.P03Treatment being tested

    Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended dose for expansion (RDE) is determined in Phase I dose escalation part of the study.

    Treatment: ALE.P03

  • Phase I Dose Expansion- ALE.P03Treatment being tested

    Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 will be given in Phase I dose expansion part of the study to identify recommended Phase II dose (RP2D) for Phase II.

    Treatment: ALE.P03

  • Phase II- ALE.P03Treatment being tested

    Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.

    Treatment: ALE.P03

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests ALE.P03 in adults with advanced CLDN1-positive solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 July 2026