Recruiting
Phase 1
Phase 2

ALE.P02

Sponsor:

Alentis Therapeutics AG

Code:

NCT06747585

Conditions

Squamous Non-small-cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Cervical Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ALE.P02

Study Details

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

Study ID

NCT06747585

Start date

Dec 16, 2024

Status verified date

Jun, 2026

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Feb 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

ALE.P02

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Alentis Clinical Trial Contact

+41782304288patientinfo@alentis.ch

Locations

Mayo Foundation for Medical Education and Research - Mayo Cl

Recruiting

Scottsdale, Arizona, United States, 85259

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Yale Comprehensive Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

The University of Chicago Medical Center - Oncology

Recruiting

Chicago, Illinois, United States, 60637

Norton Cancer Institue Downtown

Recruiting

Louisville, Kentucky, United States, 40202

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Alentis Therapeutics AG

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alentis Therapeutics AG on 2026-06-29.