NCT06747585 A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
| NCT ID | NCT06747585 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Alentis Therapeutics AG |
| Condition | Squamous Non-small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2028-02-15 |
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 170 participants in total. It began in 2024-12-16 with a primary completion date of 2028-02-15.
⚠ 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.P02 monotherapy in adult patients with selected squamous solid tumors.
Eligibility Criteria
Inclusion Criteria: * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC. * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * Have provided tissue for CLDN1 analysis in a central laboratory. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. * Demonstrate adequate bone marrow and organ function. * Patients must have recovered from all toxicities led by prior treatment. * Have measurable disease based on RECIST 1.1 as determined by the site. Exclusion Criteria: * Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain). * Patients with uncontrolled diabetes. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate. * Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06747585 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Non-small-cell Lung Cancer. 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 NCT06747585 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 NCT06747585 currently recruiting?
Yes, NCT06747585 is actively recruiting participants. Contact the research team at patientinfo@alentis.ch for enrollment information.
Where is the NCT06747585 trial being conducted?
This trial is being conducted at Scottsdale, United States, Fullerton, United States, Los Angeles, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT06747585 clinical trial?
NCT06747585 is sponsored by Alentis Therapeutics AG. The trial plans to enroll 170 participants.
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