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ALE.P03 alone for adults with advanced CLDN1-positive solid tumors

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

Phase1; Phase2 Interventional Alentis Therapeutics AG · NCT07169734

This trial tests whether ALE.P03 given alone is safe and can shrink tumors in adults with advanced CLDN1-positive cancers who have already tried standard treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorAlentis Therapeutics AG Industry-sponsored
Locations28 sites (Phoenix, Arizona and 27 other locations)
Trial IDNCT07169734 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 program gives ALE.P03 as a single agent to adults with selected advanced or metastatic CLDN1-positive solid tumors. Phase I uses dose escalation to define safety, tolerability, pharmacokinetics, pharmacodynamics and the recommended dose for expansion; Phase II treats patients at the recommended Phase II dose to measure preliminary anti-tumor activity. Eligible tumor types include colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small-cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma, with central CLDN1 testing and measurable disease per RECIST 1.1 required. Patients must have progressed on or be intolerant to standard systemic therapies and will be followed for safety and response at major US cancer centers.

Who should consider this trial

Good fit: Adults with advanced or metastatic CLDN1-positive colorectal, intrahepatic cholangiocarcinoma, squamous non-small-cell lung, urothelial, or cervical squamous cancers who have measurable disease and have progressed on or are intolerant to standard systemic therapies are ideal candidates.

Not a fit: Patients whose tumors are CLDN1-negative, who have readily available effective standard or targeted therapies, or who do not meet safety or performance-status criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ALE.P03 could provide a new targeted treatment option for patients with CLDN1-positive advanced cancers who have exhausted standard therapies.

How similar studies have performed: ALE.P03 is a first-in-human Claudin-1-targeted antibody-drug conjugate, so clinical evidence for this specific approach is limited though antibody-drug conjugates directed at other targets have shown benefit in some cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cervical Squamous Cell CarcinomaSquamous Non-small-cell Lung CancerColorectal CancerIntrahepatic CholangiocarcinomaUrothelial CarcinomaClaudin-1 Targeted Antibody-Drug ConjugateMonotherapyFirst-in-Human
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.