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

March 1, 2026 updated by: Alentis Therapeutics AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Institut Bergonie
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc - Oncologie Medicale
      • Lille, France, 59000
        • Recruiting
        • CHRU De Lille- Hôpital Claude Huriez - Medical Oncology
      • Marseille, France, 13005
        • Recruiting
        • AP-HM Hôpital de La Timone CEPCM
      • Toulouse, France, 31100
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy
  • Hong Kong
    • N.T.
      • Shatin, N.T., Hong Kong
        • Recruiting
        • Chinese University of Hong Kong - Prince of Wales Hospital
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele, IRCCS
      • Milan, Italy, 20141
        • Recruiting
        • IEO - Istituto Europeo di Oncologia, IRCCS
      • Ravenna, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci di Ravenna Oncologia
      • Roma, Italy
        • Recruiting
        • PU A. Gemelli, Università Cattolica del Sacro Cuore
      • Verona, Italy
        • Recruiting
        • Centro Ricerche Cliniche Verona
  • Singapore
    • South West
      • Singapore, South West, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, South West, Singapore, 11907
        • Recruiting
        • National University Cancer Institue
  • South Korea
      • Goyang-si, South Korea, 10408
        • Recruiting
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron
      • Barcelona, Spain, 08023
        • Recruiting
        • Next Oncology Barcelona
      • Barcelona, Spain
        • Recruiting
        • START Hospital HM Nou Delfos
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen de la Macarena
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe
    • Madrid
      • PAU de Sanchinarro, Madrid, Spain, 28050
        • Recruiting
        • START Madrid- Centro Integral Oncologico Clara Campal
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quirónsalud Madrid
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Changhua, Taiwan, 500209
        • Recruiting
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 231020
        • Recruiting
        • Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Foundation for Medical Education and Research - Mayo Cl
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center - Oncology
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institue Downtown
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I Dose Escalation- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Phase I dose escalation part of the study.
Drug: ALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.
Experimental: Phase I Dose Expansion- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study to identify Recommended Phase II Dose (RP2D) for Phase II.
Drug: ALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.
Experimental: Phase II- ALE.P02
Patients will receive ALE.P02 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.
Drug: ALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Dose Limiting Toxicities (DLTs)
Time Frame: Up to 28 days
DLTs as defines in the protocol will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).
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])
Adverse events will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).
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)
The ORR is the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) This is assessed to establish RP2D for ALE.P02 (Phase I RDE)
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)
The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR per Investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P02 (Phase I RDE).
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)
The ORR is assessed to assess anti-tumor activity of ALE.P02 (Phase II).
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)
The DoR is assessed to assess anti-tumor activity of ALE.P02 (Phase II).
From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The DCR is defined as the proportion of patients with a confirmed BOR of CR or PR or stable disease (SD) per Investigator review according to RECIST 1.1 at or prior to initiation of the use of new anti-cancer therapy. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
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
The PFS is defined as time from first study treatment to a documented disease progression according to RECIST 1.1, as determined by the Investigator, or death due to any cause, whichever occurs earlier. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
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
The OS is defined as time from first study treatment to death due to any cause. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
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)
Concentrations of ALE.P02 ADC in blood will be measured at each scheduled time point per arms to assess the pharmacokinetic (PK) profile of ALE.P02.
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)
Total antibody in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02.
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)
Concentrations of payload in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02.
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)
The AUCtau of ALE.P02 will be measured to assess the pharmacokinetic (PK) profile of ALE.P02.
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)
The AUClast of ALE.P02 will be measured to assess the PK profile of ALE.P02.
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)
The AUCinf of ALE.P02 will be measured to assess the PK profile of ALE.P02.
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)
The Cmax of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile.
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)
The Cmin of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile.
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)
The Ctrough of ALE.P02 will be measured to assess the PK profile of ALE.P02.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
The terminal elimination rate constant (KeL)
Time Frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
The KeL of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined by selection of at least three data points on the terminal phase of the concentration-time curve.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
Terminal elimination half-life (t½)
Time Frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
The t½ of ALE.P02 will be measured to assess the PK profile of ALE.P02.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
Time of Maximum Concentration (tmax)
Time Frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
The tmax of ALE.P02 will be measured to assess the PK profile of ALE.P02.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
Average Concentration (Cavg)
Time Frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
The Cavg of ALE.P02 will be measured to assess the PK profile of ALE.P02.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
Number of Patients with Presence of anti-ALE.P02 Antibodies
Time Frame: Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)
Presence of anti-ALE.P02 Antibodies will be assessed to evaluate the immunogenicity of ALE.P02.
Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alentis Therapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

August 15, 2028

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALE.P02.01
  • 2024-515459-39-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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