AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAlentis Therapeutics AG
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • ALE.P03
  • ALE.P03
  • ALE.P03
๐Ÿ“

Where

41 sites
Mayo Clinic Comprehensive Cancer Center
Phoenix, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Yale Comprehensive Cancer Center
New Haven, United States
The University of Chicago Medical Center - Oncology
Chicago, United States
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, United States
John Theurer Cancer Center
Hackensack, United States
MD Anderson Cancer Center
Houston, United States
Next Oncology-Oncology
San Antonio, United States

โ€ฆand 33 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy