NCT07169734 A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
| NCT ID | NCT07169734 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Alentis Therapeutics AG |
| Condition | Cervical Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2029-04-05 |
Trial Parameters
Eligibility Fast-Check
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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.P03 monotherapy in adult patients with selected squamous solid tumors.
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 performa