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RecruitingPhase 1 / Phase 2

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

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ALE.P03 alone in adults with certain advanced cancers or cancers that have spread and have a protein called CLDN1. It checks side effects, how the drug works in the body, and early signs that it fights cancer. It also aims to find a dose for the next study phase.

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.P03 monotherapy in adult patients with selected squamous solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed advanced or spread cancer of the colon or rectum, bile ducts inside the liver, urinary tract lining, or certain types of lung or cervical cancer called squamous cancers.
  • Have scans showing that the cancer is getting worse when you enter the study.
  • Provide a tumor tissue sample for CLDN1 testing at a central lab.
  • For the dose-increase phase: standard treatments for advanced cancer did not work or caused side effects you could not tolerate.
  • For later phases: have tried 1–2 standard treatments for advanced cancer that did not work or caused side effects you could not tolerate. If your cancer has gene changes that can be targeted, have received suitable targeted treatment.
  • Have cancer that the study team can measure on scans.
  • Be fully active, or able to walk and do light work despite limits on hard physical activity.
  • Have bone marrow, which makes blood cells, and organs that work well enough under the study rules.

Who can't join

  • For lung or cervical cancer: the tumor is mostly not squamous cancer, or is a type called adenocarcinoma.
  • Have received cancer treatment too close to the start of study treatment, based on the study rules.
  • Have cancer that is getting worse quickly.
  • Have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.
  • Have had lung inflammation not caused by infection that needed steroids, or have current lung inflammation with symptoms or major health effects that needs steroids or drugs that weaken the immune system.
  • Have serious bleeding in the stomach or intestines.
  • Have an active infection that needs treatment affecting the whole body.
  • Have a past or current health condition, treatment, or abnormal lab result that could make the study results hard to interpret.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Phase I Dose Escalation: \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease. Phase I RDE and Phase II: * 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. Applicable for Phase I Dose Escalation, Phase I RDE and Phase II: * 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 Criteria: * 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.

Study sites (9)

AZ

  • Mayo Clinic Comprehensive Cancer Center · Phoenix, AZ 85054Principal Investigator · Study contactMore trials in Phoenix

CA

CT

IL

  • The University of Chicago Medical Center - Oncology · Chicago, IL 60637Principal Investigator · Study contactPrincipal Investigator · Principal investigatorMore trials in Chicago

KY

  • Norton Cancer Institute - Norton Healthcare Pavilion · Louisville, KY 40202Principal Investigator · Study contactMore trials in Louisville

NJ

TX

VA