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

NCT06747585 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: ALE.P02.012024-515459-39-00
• Study Type: interventional
• Target: 170
• Locations: 8 countries
• Sites: 38

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.P02 monotherapy in adult patients with selected squamous solid tumors.

Conditions

Squamous Non-small-cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Esophageal Squamous Cell 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)

  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

  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)

  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)

  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)

  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)

  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 Outcomes (17)

• Disease control rate (DCR) (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)

  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)

  At 6, 12, and 24 months after initiation of ALE.P02 treatment

• Blood Concentration of ALE.P02 Antibody-drug Conjugate (ADC)

  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

  Phase I and II: Cycle 1 Day 1 until at EoT (Up to 3.5 years)

Study Arms (3)

Phase I Dose Escalation- ALE.P02

EXPERIMENTAL

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

Phase I Dose Expansion- ALE.P02

EXPERIMENTAL

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

Phase II- ALE.P02

EXPERIMENTAL

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

Interventions

ALE.P02 DRUG

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

Phase I Dose Escalation- ALE.P02; Phase I Dose Expansion- ALE.P02; Phase II- ALE.P02

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alentis Therapeutics AG: lead

Study Sites (38)

Mayo Foundation for Medical Education and Research - Mayo Cl

Scottsdale, Arizona, 85259, United States

RECRUITING

Providence Medical Foundation

Fullerton, California, 92835, 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

The University of Chicago Medical Center - Oncology

Chicago, Illinois, 60637, United States

RECRUITING

Norton Cancer Institue Downtown

Louisville, Kentucky, 40202, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Institut Bergonie

Bordeaux, 33000, France

RECRUITING

Centre Georges Francois Leclerc - Oncologie Medicale

Dijon, 21079, France

RECRUITING

CHRU De Lille- Hôpital Claude Huriez - Medical Oncology

Lille, 59000, France

RECRUITING

AP-HM Hôpital de La Timone CEPCM

Marseille, 13005, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole

Toulouse, 31100, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Chinese University of Hong Kong - Prince of Wales Hospital

Shatin, N.T., Hong Kong

RECRUITING

Ospedale San Raffaele, IRCCS

Milan, 20132, Italy

RECRUITING

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, 20141, Italy

RECRUITING

Ospedale Santa Maria delle Croci di Ravenna Oncologia

Ravenna, 48121, Italy

RECRUITING

PU A. Gemelli, Universita Cattolica del Sacro Cuore

Roma, Italy

RECRUITING

Centro Ricerche Cliniche Verona

Verona, Italy

RECRUITING

National University Cancer Institue

Singapore, South West, 11907, Singapore

RECRUITING

National Cancer Centre Singapore

Singapore, South West, 168583, Singapore

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

START Madrid- Centro Integral Oncologico Clara Campal

PAU de Sanchinarro, Madrid, 28050, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

NEXT Oncology Barcelona

Barcelona, 08023, Spain

RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

START Hospital HM Nou Delfos

Barcelona, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen De La Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen De La Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 50006, Taiwan

RECRUITING

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 500209, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital

Taipei, 231020, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Alentis Clinical Trial Contact

CONTACT

+41782304288; patientinfo@alentis.ch

Study Design

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

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

FR (6); ES (9); TW (4); KR (3); IT (5); US (8); HK (1); SG (2)