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A Study of ALE.P02 for CLDN1+ Solid Tumors

This study is testing a new drug called ALE.P02 in adults with certain advanced or metastatic squamous (a type of cell) solid tumors, including lung, head and neck, cervical, and esophageal cancers. You might be able to join if you have one of these cancers and have already received at least one standard treatment that didn't work or you couldn't tolerate. The main goals are to see how safe ALE.P02 is, what side effects it causes, and if it can shrink tumors. The study is currently recruiting about 170 participants, but its exact status is unclear.

Study design
This study involves a dose escalation phase (Phase I) to find the best dose of ALE.P02, followed by a Phase II study using that dose. It is an interventional study, meaning participants will receive the study drug.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for about 30 days after your last dose of ALE.P02, and your tumor response will be tracked for up to 3.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06747585

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alentis Therapeutics AG
~170 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:ALE.P02

At a glance

Recruiting sites
41 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Dose Limiting Toxicities (DLTs)
Measured over Up to 28 days
+5 more outcomes measured

Conditions

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

Explore related trials

Cervical Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmCLDN1 Gene

Where it's being run

41 sites across 15 states
Italy7
Spain7
France6
South Korea4
Taiwan4
California2
South West2
Madrid2

Who to contact

Alentis Clinical Trial Contact
[email protected]
+41782304288
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

  • Number of Patients with Adverse EventsScreening (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).

  • Overall Response Rate (ORR) (Phase I)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)

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

  • Overall Response Rate (ORR) (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)

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

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