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

Study Identifier:
ALE-P03-01
CT.gov Identifier:
NCT07169734
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521441-24-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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.

To study the effect of ALE.P03 in patients CLDN1+ solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Cervical cancer
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
  • Bile Duct
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Cervical cancer
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Bile Duct
    Urinary tract
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Cervical cancer
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Bile Duct
    Urinary tract
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Cervical cancer
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Bile Duct
    Urinary tract