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Recruiting NCT06747585

A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

Phase I / Phase II Interventional Squamous Non-small-cell Lung Cancer Head and Neck Squamous Cell Carcinoma Cervical Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALE.P02.
Who it may be relevant to
Registry conditions: Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Hong Kong, Italy, Singapore +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.

Interventions

  • Drug ALE.P02
    ALE.P02, will be administered by IV infusion according to the assigned arms.

Primary outcome measures

  • Number of Patients with Dose Limiting Toxicities (DLTs) [Time frame: Up to 28 days]
  • Number of Patients with Adverse Events [Time frame: Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 years])]
  • Overall Response Rate (ORR) (Phase I) [Time frame: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)]
  • Duration of Response (DoR) (Phase I) [Time frame: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)]
  • Overall Response Rate (ORR) (Phase II) [Time frame: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)]
  • Duration of Response (DoR) (Phase II) [Time frame: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)]
Secondary outcome measures (12)
  • Disease control rate (DCR) (Phase I and II) [Time frame: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)]
  • Median Progression-Free Survival (PFS) at 6 and 12 Months (Phase I and II) [Time frame: At 6 and 12 months after initiation of ALE.P02 treatment]
  • Median Overall Survival (OS) at 6, 12, and 24 Months (Phase I and II) [Time frame: At 6, 12, and 24 months after initiation of ALE.P02 treatment]
  • Blood Concentration of ALE.P02 Antibody-drug Conjugate (ADC) [Time frame: Phase I and II: Cycle 1 Day 1 until at end of treatment visit (EoT) (Up to 3.5 years)]
  • Blood Concentration of Total Antibody [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Blood Concentrations of Payload [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Area under the concentration-time curve over the dosing interval (AUCtau) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Maximum Concentration (Cmax) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Minimum concentration (Cmin) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]
  • Concentration at the end of a Dosing Interval (Ctrough) [Time frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 9 centers
  • START Madrid- Centro Integral Oncologico Clara Campal — PAU de Sanchinarro
  • Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón
  • NEXT Oncology Barcelona — Barcelona
  • Hospital Universitari Vall D Hebron — Barcelona
  • START Hospital HM Nou Delfos — Barcelona
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Universitario Virgen De La Victoria — Málaga
  • Hospital Universitario Virgen De La Macarena — Seville
  • … and 1 more center
United States · 8 centers
  • Mayo Foundation for Medical Education and Research - Mayo Cl — Scottsdale
  • Providence Medical Foundation — Fullerton
  • USC Norris Comprehensive Cancer Center — Los Angeles
  • Yale Comprehensive Cancer Center — New Haven
  • The University of Chicago Medical Center - Oncology — Chicago
  • Norton Cancer Institue Downtown — Louisville
  • Hackensack University Medical Center — Hackensack
  • NEXT Oncology Virginia — Fairfax
Italy · 7 centers
  • Istituto Clinico Humanitas — Milan
  • Ospedale San Raffaele, IRCCS — Milan
  • Istituto Nazionale del Tumori, Fondazione IRCCS — Milan
  • IEO - Istituto Europeo di Oncologia, IRCCS — Milan
  • Ospedale Santa Maria delle Croci di Ravenna Oncologia — Ravenna
  • PU A. Gemelli, Universita Cattolica del Sacro Cuore — Roma
  • Centro Ricerche Cliniche Verona — Verona
France · 6 centers
  • Institut Bergonie — Bordeaux
  • Centre Georges Francois Leclerc - Oncologie Medicale — Dijon
  • CHRU De Lille- Hôpital Claude Huriez - Medical Oncology — Lille
  • AP-HM Hôpital de La Timone CEPCM — Marseille
  • Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole — Toulouse
  • Institut Gustave Roussy — Villejuif
South Korea · 4 centers
  • National Cancer Center — Goyang-si
  • Seoul National University Hospital — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul
  • Asan Medical Center - Oncology — Seoul
Taiwan · 4 centers
  • Changhua Christian Medical Foundation Changhua Christian Hospital — Changhua
  • Changhua Christian Medical Foundation Changhua Christian Hospital — Changhua
  • National Taiwan University Hospital — Taipei
  • Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital — Taipei
Singapore · 2 centers
  • National University Cancer Institue — Singapore
  • National Cancer Centre Singapore — Singapore
Hong Kong · 1 center
  • Chinese University of Hong Kong - Prince of Wales Hospital — Shatin

Identifiers

NCT: NCT06747585 · ALE.P02.01 · 2024-515459-39-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗