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Study of ALE.P03 for Advanced CLDN1+ Solid Tumors

This study is testing a new treatment called ALE.P03 for adults with certain advanced or metastatic solid tumors, including cervical, lung, colorectal, intrahepatic cholangiocarcinoma, and urothelial cancers. The treatment, ALE.P03, is a targeted therapy given through an IV. To join, your tumor must have a specific marker called CLDN1 (Claudin-1) and your cancer must have progressed. Researchers want to see how safe ALE.P03 is, how well your body handles it, and if it can shrink tumors. Success would mean fewer serious side effects and tumors getting smaller. The study is currently recruiting about 180 participants.

Study design
This is an interventional study with a planned enrollment of 180 participants. It includes a Phase I part to find the right dose and a Phase II part to further evaluate the treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for about 30 days after their last dose, and for overall response for up to 4 years after starting ALE.P03 treatment.

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

NCT07169734

A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alentis Therapeutics AG
~180 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:ALE.P03

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) (Phase I)
Measured over Up to 28 days
+5 more outcomes measured

Conditions

Cervical Squamous Cell Carcinoma
Squamous Non-small-cell Lung Cancer
Colorectal Cancer
Intrahepatic Cholangiocarcinoma
Urothelial Carcinoma

Explore related trials

Cervical Squamous Cell CarcinomaColorectal CarcinomaIntrahepatic CholangiocarcinomaLung Non-Small Cell Squamous CarcinomaSolid NeoplasmUrothelial CarcinomaCLDN1 Gene

Where it's being run

41 sites across 15 states
Spain12
Italy7
France4
Netherlands3
Taiwan3
Texas2
Singapore2
Arizona1

Who to contact

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

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Eligibility criteria

Inclusion

Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
Have documented radiological disease progression at study entry.
Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
Patients with actionable oncogenic drivers: received feasible targeted therapy.
Measurable disease per RECIST 1.1, as determined by the site.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
Demonstrate adequate bone marrow and organ function as per the protocol.

Exclusion

SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
Has received antineoplastic therapies prior to study intervention within specified time frame.
Has rapidly progressing disease.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
Has clinically significant gastrointestinal bleeding.
Has an active infection requiring systemic treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

What this trial measures

  • Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)Up to 28 days

    DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).

  • Number of Patients with Adverse Events (Phase I)From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])

    Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).

  • Overall Response Rate (ORR) (Phase I)From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 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.P03 (Phase I RDE)

  • Duration of Response (DoR) (Phase I)From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)

    The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE).

  • Overall Response Rate (ORR) (Phase II)From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)

    The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II).

  • Duration of Response (DoR) (Phase II)From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)

    The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to assess anti-tumor activity of ALE.P03 (Phase II).