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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2025-08-26 with a primary completion date of 2029-04-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07169734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07169734 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07169734 currently recruiting?
Yes, NCT07169734 is actively recruiting participants. Contact the research team at patientinfo@alentis.ch for enrollment information.
Where is the NCT07169734 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, New Haven, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT07169734 clinical trial?
NCT07169734 is sponsored by Alentis Therapeutics AG. The trial plans to enroll 180 participants.