A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors

Study Identifier:
ALE-P02-01
CT.gov Identifier:
NCT06747585
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-515459-39-00
Study Contact Information:
(210) 593-5651 or [email protected]
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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.P02 monotherapy in adult patients with selected squamous solid tumors.

To study the effect of ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin

Main objective

To evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation). To establish RP2D for ALE.P02 (Phase I RDE). To assess anti-tumor activity of ALE.P02 (Phase II)

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.
  • Non-Small Cell Lung Cancer
  • Head & Neck
  • Cervical cancer
  • Esophageal
    • 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
  • Drug: Experimental: Phase I Dose Escalation- ALE.P02
    • Read More
  • Drug: Experimental: Phase I Dose Expansion- ALE.P02
  • Drug: Experimental: Phase II- ALE.P02
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
    • * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
    • * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
    • * Have provided tissue for CLDN1 analysis in a central laboratory.
    • * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
    • * Demonstrate adequate bone marrow and organ function.
    • * Patients must have recovered from all toxicities led by prior treatment.
    • * Have measurable disease based on RECIST 1.1 as determined by the site.
    Exclusion criteria
    • * Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
    • * Has received antineoplastic therapies prior to study intervention within specified time frame.
    • * Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
    • * Patients with uncontrolled diabetes.
    • * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
    • * Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
    • * Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Head & Neck
    Cervical cancer
    Esophageal
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Head & Neck
    Cervical cancer
    Esophageal