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NCT Number: NCT06747585

A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected 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.P02 monotherapy in adult patients with selected squamous solid tumors.

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Key information

Conditions

Squamous Non-small-cell Lung Cancer Carcinoma Carcinoma, Squamous Cell Cervical Squamous Cell Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut Bergonie, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALE.P02

Drug

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

Primary outcomes

  1. Number of Patients with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 28 days

    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).

  2. 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])

    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).

  3. 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)

    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)

  4. Duration of Response (DoR) (Phase I)

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

    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).

  5. 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)

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

  6. Duration of Response (DoR) (Phase II)

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

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

Secondary outcomes

  1. 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)

    The DCR is defined as the proportion of patients with a confirmed 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.P02 (Phase I and II).

  2. 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

    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.P02 (Phase I and II).

  3. 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

    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.P02 (Phase I and II).

  4. 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)

    Concentrations of ALE.P02 ADC in blood will be measured at each scheduled time point per arms to assess the pharmacokinetic (PK) profile of ALE.P02.

  5. Blood Concentration of Total Antibody

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

    Total antibody in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02.

  6. Blood Concentrations of Payload

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

    Concentrations of payload in blood will be measured at each scheduled time point per arms to assess the PK profile of ALE.P02.

  7. 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)

    The AUCtau of ALE.P02 will be measured to assess the pharmacokinetic (PK) profile of ALE.P02.

  8. 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)

    The AUClast of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  9. 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)

    The AUCinf of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  10. Maximum Concentration (Cmax)

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

    The Cmax of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile.

  11. Minimum concentration (Cmin)

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

    The Cmin of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined directly from the concentration-time profile.

  12. 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 Ctrough of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  13. The terminal elimination rate constant (KeL)

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

    The KeL of ALE.P02 will be measured to assess the PK profile of ALE.P02. It is determined by selection of at least three data points on the terminal phase of the concentration-time curve.

  14. Terminal elimination half-life (t½)

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

    The t½ of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  15. Time of Maximum Concentration (tmax)

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

    The tmax of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  16. Average Concentration (Cavg)

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

    The Cavg of ALE.P02 will be measured to assess the PK profile of ALE.P02.

  17. 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)

    Presence of anti-ALE.P02 Antibodies will be assessed to evaluate the immunogenicity of ALE.P02.

Study contacts

Contact information is provided by the study sponsor or research team.

Alentis Clinical Trial Contact

CONTACT

[email protected]

+41782304288

Sponsors and collaborators

Lead sponsor

Alentis Therapeutics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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