Status:
RECRUITING
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Lead Sponsor:
Alentis Therapeutics AG
Conditions:
Cervical Squamous Cell Carcinoma
Squamous Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.P...
Detailed Description
This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 as monotherapy at RP2D in adult patients with selected advan...
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.
- 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
- 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.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 4 2029
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07169734
Start Date
August 26 2025
End Date
October 4 2029
Last Update
December 18 2025
Active Locations (7)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06510
3
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
4
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601