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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Comprehensive Cancer Center
  Phoenix, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Yale Comprehensive Cancer Center
  New Haven, Connecticut, United States Recruiting
• The University of Chicago Medical Center - Oncology
  Chicago, Illinois, United States Recruiting
• Norton Cancer Institute - Norton Healthcare Pavilion
  Louisville, Kentucky, United States Recruiting
• John Theurer Cancer Center
  Hackensack, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Alentis Clinical Trial Contact
• Email: patientinfo@alentis.ch
• Phone: +41782304288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.