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NCT06747585 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma, sponsored by Alentis Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
- 20
- Study locations
NCT06747585: Recruiting Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma, sponsored by Alentis Therapeutics.
NCT06747585 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma that is actively recruiting participants, run by Alentis Therapeutics. The registered enrollment target is 170 participants, above the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06747585, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Esophageal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Alentis Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
DLTs as defines in the protocol will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).
Conditions Studied
Interventions
- DRUG ALE.P02
Study Locations (20)
Other
- Institut Bergonie - Bordeaux
- Centre Georges Francois Leclerc - Oncologie Medicale - Dijon
- CHRU De Lille- Hôpital Claude Huriez - Medical Oncology - Lille
- AP-HM Hôpital de La Timone CEPCM - Marseille
- Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole - Toulouse
- Institut Gustave Roussy - Villejuif
- Ospedale San Raffaele, IRCCS - Milan
- IEO - Istituto Europeo di Oncologia, IRCCS - Milan
- Ospedale Santa Maria delle Croci di Ravenna Oncologia - Ravenna
- PU A. Gemelli, Universita Cattolica del Sacro Cuore - Roma
- Centro Ricerche Cliniche Verona - Verona
California
- Providence Medical Foundation - Fullerton
- USC Norris Comprehensive Cancer Center - Los Angeles
Arizona
- Mayo Foundation for Medical Education and Research - Mayo Cl - Scottsdale
Connecticut
- Yale Comprehensive Cancer Center - New Haven
Illinois
- The University of Chicago Medical Center - Oncology - Chicago
Kentucky
- Norton Cancer Institue Downtown - Louisville
New Jersey
- Hackensack University Medical Center - Hackensack
Virginia
- NEXT Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2028-08-15 |
| Phase | Phase 1 |
What NCT06747585 shows while recruiting
NCT06747585 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (47% higher).
The record links to 4 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which ALE.P02 is the first listed.
NCT06747585 names 20 study sites across 9 states, led by Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06747585 about?
NCT06747585 is a clinical study titled "A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors". 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.
What is the current status of trial NCT06747585?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2024-12-16. Estimated completion is 2028-08-15.
What conditions does trial NCT06747585 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06747585?
The interventions under investigation include: ALE.P02 (DRUG).
Who is sponsoring clinical trial NCT06747585?
This trial is sponsored by Alentis Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06747585 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06747585's enrollment target sits among peer trials
170 24th of 124 higher than 101 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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