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

NCT07169734 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: ALE.P03.012025-521441-24-00
• Study Type: interventional
• Target: 180
• Locations: 7 countries
• Sites: 28

Brief 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.

Conditions

Cervical Squamous Cell Carcinoma; Colorectal Cancer; Squamous Non-small-cell Lung Cancer; Intrahepatic Cholangiocarcinoma; Urothelial Carcinoma

Keywords

Claudin-1 Targeted Antibody-Drug Conjugate; Monotherapy; First-in-Human; Recommended Phase 2 dose; Recommended dose for expansion

Outcome Measures

Primary Outcomes (6)

• Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (19)

• Number of Patients with Adverse Events (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)

  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)

  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)

  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)

  Phase I and II: From Day 1 until at end of treatment visit (EoT) (Up to 4 years)

Study Arms (3)

Phase I Dose Escalation- ALE.P03

EXPERIMENTAL

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

Phase I Dose Expansion- ALE.P03

EXPERIMENTAL

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

Phase II- ALE.P03

EXPERIMENTAL

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

Interventions

ALE.P03 DRUG

ALE.P03, will be administered by IV infusion according to the assigned arms.

Phase I Dose Escalation- ALE.P03

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alentis Therapeutics AG: lead

Study Sites (28)

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona, 85054, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Norton Cancer Institute - Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Next Oncology-Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Institut Gustave Roussy (IGR)

Villejuif, 94800, France

RECRUITING

Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)

Hong Kong, Hong-Kong, Hong Kong

RECRUITING

Ospedale San Raffaele, IRCCS - Oncologia Medica

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, 20141, Italy

RECRUITING

Radboudumc - Centrum voor Oncologie

Nijmegen, 6525, Netherlands

RECRUITING

National University Hospital (NUH) - Medical Oncology

Singapore, 119074, Singapore

RECRUITING

National Cancer Centre Singapore (NCCS)

Singapore, 168583, Singapore

RECRUITING

Hospital HM Nou Delfos

Barcelona, 08023, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

See outside Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Virgen of Arrixaca University Clinical Hospital

El Palmar, 30120, Spain

RECRUITING

Ramón y Cajal Hospital

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

HM Sanchinarro University Hospital

Madrid, 28050, Spain

RECRUITING

University Hospital Quironsalud Madrid

Madrid, 28223, Spain

RECRUITING

Hospital universitario virgen macarena

Seville, 41009, Spain

RECRUITING

San Juan de Reus University Hospital

Tarragona, 43204, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

La Fe University and Polytechnic Hospital

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Cholangiocarcinoma; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Alentis Clinical Trial Contact

CONTACT

+41782304288; patientinfo@alentis.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For Phase I recommended dose for expansion (RDE) part of the study, patients will be randomized in 1:1 ratio to identify the recommended Phase II dose (RP2D) for Phase II.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 12, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): April 5, 2029
• Study Completion (Estimated): October 4, 2029
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); US (8); FR (1); HK (1); IT (3); NL (1); ES (12)