A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

July 1, 2026 updated by: Alentis Therapeutics AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.

Study Type

Interventional

Enrollment (Estimated)

180

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
      • Dijon, France, 21000
        • Recruiting
        • Centre Georges Francois Leclerc - Oncologie Medicale
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Marseille, France, 13005
        • Recruiting
        • CHU La Timone
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Toulouse, France, 31100
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy (Igr)
        • Contact:
          • Principal Investigator
  • Hong Kong
    • Hong-Kong
      • Hong Kong, Hong-Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)
        • Contact:
          • Principal Investigator
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Principal Investigator
      • Milan, Italy, 20141
        • Recruiting
        • IEO - Istituto Europeo di Oncologia, IRCCS
        • Contact:
          • Principal Investigator
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele, IRCCS - Oncologia Medica
        • Contact:
          • Principal Investigator
      • Milan, Italy, 20162
        • Recruiting
        • Oncologo presso Ospedale ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Ravenna, Italy, 48121
        • Recruiting
        • Ravenna - Ospedale S. Maria delle Croci
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Rossano, Italy, 20089
        • Recruiting
        • IRCCS Istituto Clinico Humanitas di Rozzano
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Siena, Italy, 53100
        • Recruiting
        • Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncologica
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • Recruiting
        • The Netherlands Cancer Institute (NKI)
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Nijmegen, Netherlands, 6525
        • Recruiting
        • Radboudumc - Centrum voor Oncologie
        • Contact:
          • Principal Investigator
      • Rotterdam, Netherlands, 3015
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
  • Singapore
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore (NCCS)
        • Contact:
          • Principal Investigator
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital (NUH) - Medical Oncology
        • Contact:
          • Principal Investigator
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebrón University Hospital
        • Contact:
          • Principal Investigator
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital HM Nou Delfos
        • Contact:
          • Principal Investigator
      • Córdoba, Spain, 14004
        • Recruiting
        • See outside Hospital Universitario Reina Sofia
        • Contact:
          • Principal Investigator
      • El Palmar, Spain, 30120
        • Recruiting
        • Virgen of Arrixaca University Clinical Hospital
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28034
        • Recruiting
        • Ramón y Cajal Hospital
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28050
        • Recruiting
        • HM Sanchinarro University Hospital
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28223
        • Recruiting
        • University Hospital Quironsalud Madrid
        • Contact:
          • Principal Investigator
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Principal Investigator
      • Tarragona, Spain, 43204
        • Recruiting
        • San Juan de Reus University Hospital
        • Contact:
          • Principal Investigator
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
          • Principal Investigator
      • Valencia, Spain, 46026
        • Recruiting
        • La Fe University and Polytechnic Hospital
        • Contact:
          • Principal Investigator
  • Taiwan
      • Tainan, Taiwan, 100225
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Oncology
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Comprehensive Cancer Center
        • Contact:
          • Principal Investigator
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
        • Contact:
          • Principal Investigator
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Comprehensive Cancer Center
        • Contact:
          • Principal Investigator
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center - Oncology
        • Contact:
          • Principal Investigator
        • Principal Investigator:
          • Principal Investigator
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute - Norton Healthcare Pavilion
        • Contact:
          • Principal Investigator
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center
        • Contact:
          • Principal Investigator
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Md Anderson Cancer Center
        • Contact:
          • Principal Investigator
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Next Oncology-Oncology
        • Contact:
          • Principal Investigator
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology Virginia
        • Contact:
          • Principal Investigator

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 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.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I Dose Escalation- ALE.P03
Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 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.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Experimental: Phase I Dose Expansion- ALE.P03
Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 will be given in Phase I dose expansion part of the study to identify recommended Phase II dose (RP2D) for Phase II.
Drug: ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Experimental: Phase II- ALE.P03
Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.
Drug: ALE.P03
ALE.P03, 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) (Phase I)
Time Frame: Up to 28 days
DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
Up to 28 days
Number of Patients with Adverse Events (Phase I)
Time Frame: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])
Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])
Overall Response Rate (ORR) (Phase I)
Time Frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 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.P03 (Phase I RDE)
From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
Duration of Response (DoR) (Phase I)
Time Frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE).
From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
Overall Response Rate (ORR) (Phase II)
Time Frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
Duration of Response (DoR) (Phase II)
Time Frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Adverse Events (Phase I RDE and Phase II)
Time Frame: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years]
Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I RDE and Phase II)
From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years]
Disease control rate (DCR) (Phase I and II)
Time Frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
The DCR is defined as the proportion of patients with a 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.P03 (Phase I and II).
From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
Median Progression-Free Survival (PFS) rate at 6 and 12 Months (Phase I and II)
Time Frame: At 6 and 12 months after initiation of ALE.P03 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.P03 (Phase I and II).
At 6 and 12 months after initiation of ALE.P03 treatment
Median Overall Survival (OS) rate at 6, 12, and 24 Months (Phase I and II)
Time Frame: At 6, 12, and 24 months after initiation of ALE.P03 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.P03 (Phase I and II).
At 6, 12, and 24 months after initiation of ALE.P03 treatment
Blood Concentration of ALE.P03 Antibody-drug Conjugate (ADC) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at end of treatment visit (EoT) (Up to 4 years)
Concentrations of ALE.P03 ADC in blood will be measured at each scheduled time point per arms.
Phase I and II: From Day 1 until at end of treatment visit (EoT) (Up to 4 years)
Blood Concentrations of Total Antibody (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Concentrations of total antibody in blood will be measured at each scheduled time point per arms.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Blood Concentrations of Payload (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Concentrations of payload in blood will be measured at each scheduled time point per arms.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Area under the concentration-time curve over the dosing interval (AUCtau) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The AUCtau of ALE.P03 will be measured to assess the pharmacokinetic (PK) profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The AUClast of ALE.P03 will be measured to assess the PK profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The AUCinf of ALE.P03 will be measured to assess the PK profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Maximum Concentration (Cmax) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The Cmax of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Minimum concentration (Cmin) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The Cmin of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Concentration at the end of a dosing interval (Ctrough) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The Ctrough of ALE.P03 will be measured to assess the PK profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
The terminal elimination rate constant (KeL) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The KeL of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined by selection of at least three data points on the terminal phase of the concentration-time curve.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Terminal elimination half-life (t½) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The t½ of ALE.P03 will be measured to assess the PK profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Time of Maximum Concentration (tmax) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The tmax of ALE.P03 will be measured to assess the PK profile of ALE.P03. It is determined directly from the concentration-time profile.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Average Concentration (Cavg) (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
The Cavg of ALE.P03 will be measured to assess the PK profile of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Number of Patients with Presence of anti-ALE.P03 Antibodies (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Presence of anti-ALE.P03 Antibodies will be assessed to evaluate the immunogenicity of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 years)
Number of Patients with Positive anti-ALE.P03 Antibodies (Phase I and II)
Time Frame: Phase I and II: From Day 1 until at EoT (Up to 4 years)
Presence of anti-ALE.P03 Antibodies (positive/negative) will be assessed to evaluate the immunogenicity of ALE.P03.
Phase I and II: From Day 1 until at EoT (Up to 4 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)

August 26, 2025

Primary Completion (Estimated)

April 5, 2029

Study Completion (Estimated)

October 4, 2029

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALE.P03.01
  • 2025-521441-24-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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