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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06747585Sponsor: Alentis Therapeutics AGLast updated: 2026-03-03

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.

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.

Arms & interventions

  • DrugALE.P02

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

Outcome measures

Primary

  • 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).

    Time frame: 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).

    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)

    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)

    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)

    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).

    Time frame: 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).

    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)

    The DoR is assessed to assess anti-tumor activity of ALE.P02 (Phase II).

    Time frame: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)

Secondary

  • 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)

  • 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

  • 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

  • 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)

  • Blood Concentration of Total Antibody

    Time frame: 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)

  • 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)

  • 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)

  • 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)

  • Maximum Concentration (Cmax)

    Time frame: 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)

  • 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 terminal elimination rate constant (KeL)

    Time frame: 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)

  • Time of Maximum Concentration (tmax)

    Time frame: 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)

  • 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)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

Mayo Foundation for Medical Education and Research - Mayo Cl

Scottsdale, Arizona, 85259

Recruiting

Providence Medical Foundation

Fullerton, California, 92835

Recruiting

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06510

Recruiting

The University of Chicago Medical Center - Oncology

Chicago, Illinois, 60637

Recruiting

Norton Cancer Institue Downtown

Louisville, Kentucky, 40202

Recruiting

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

NEXT Oncology Virginia

Fairfax, Virginia, 22031

Recruiting