ALE.P03 for Advanced Solid Tumors

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

Recruiting Phase 1 Phase 2 Interventional Study
Cervical Squamous Cell Carcinoma Squamous Non-small-cell Lung Cancer Colorectal Cancer Intrahepatic Cholangiocarcinoma Urothelial Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Alentis Therapeutics AG · Industry
Who this trial is looking for

This trial is looking for adults with certain advanced cancers to see if a new treatment, ALE.P03, is safe and effective. Participants will need to provide tissue samples and have documented disease progression.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced colorectal cancer.
  • I have been diagnosed with intrahepatic cholangiocarcinoma.
  • I have been diagnosed with squamous non-small cell lung cancer.
  • I have been diagnosed with urothelial carcinoma.
  • I have been diagnosed with cervical squamous cell carcinoma.
  • I have shown disease progression before joining the study.
  • I have tissue samples available for analysis.
  • I have a performance status of 0 or 1.

You may not be able to join if

  • I have a tumor that is predominantly of non-squamous histology.
  • I have received certain cancer treatments within the last few weeks.
  • I have rapidly progressing disease.
  • I have known active central nervous system metastases.
  • I have a history of certain lung diseases that required steroid treatment.
  • I have significant gastrointestinal bleeding.
  • I have an active infection that needs treatment.
  • I have any condition that might affect the results of the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 progres…
Contacts

Alentis Clinical Trial Contact

+41782304288

patientinfo@alentis.ch

CONTACT