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NCT07169734 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
A Phase 1 study of Colorectal Cancer and Urothelial Carcinoma, sponsored by Alentis Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT07169734: Recruiting Phase 1 study of Colorectal Cancer and Urothelial Carcinoma, sponsored by Alentis Therapeutics.
NCT07169734 is a Phase 1 study of Colorectal Cancer and Urothelial Carcinoma that is actively recruiting participants, run by Alentis Therapeutics. The registered enrollment target is 180 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07169734, a Phase 1 study of Colorectal Cancer and Urothelial Carcinoma, is actively recruiting participants, sponsored by Alentis Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 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.P03 monotherapy in adult patients with selected squamous solid tumors.
Primary Outcome
DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
Conditions Studied
Interventions
- DRUG ALE.P03
Study Locations (20)
Other
- Institut Gustave Roussy (IGR) - Villejuif
- Ospedale San Raffaele, IRCCS - Oncologia Medica - Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- IEO - Istituto Europeo di Oncologia, IRCCS - Milan
- Radboudumc - Centrum voor Oncologie - Nijmegen
- National University Hospital (NUH) - Medical Oncology - Singapore
- National Cancer Centre Singapore (NCCS) - Singapore
- Hospital HM Nou Delfos - Barcelona
- Vall d'Hebron University Hospital - Barcelona
- See outside Hospital Universitario Reina Sofia - Córdoba
- Virgen of Arrixaca University Clinical Hospital - El Palmar
Texas
- MD Anderson Cancer Center - Houston
- Next Oncology-Oncology - San Antonio
Arizona
- Mayo Clinic Comprehensive Cancer Center - Phoenix
California
- USC Norris Comprehensive Cancer Center - Los Angeles
Connecticut
- Yale Comprehensive Cancer Center - New Haven
Kentucky
- Norton Cancer Institute - Norton Healthcare Pavilion - Louisville
New Jersey
- John Theurer Cancer Center - Hackensack
Virginia
- NEXT Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2029-10-04 |
| Phase | Phase 1 |
What NCT07169734 shows while recruiting
NCT07169734 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (88% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which ALE.P03 is the first listed.
NCT07169734 names 20 study sites across 9 states, led by Other, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT07169734 about?
NCT07169734 is a clinical study titled "A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic 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.P03 monotherapy in adult patients with selected squamous solid tumors.
What is the current status of trial NCT07169734?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2025-08-26. Estimated completion is 2029-10-04.
What conditions does trial NCT07169734 study?
This clinical trial studies the following conditions: Colorectal Cancer, Urothelial Carcinoma, Intrahepatic Cholangiocarcinoma, Cervical Squamous Cell Carcinoma, Squamous Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT07169734?
The interventions under investigation include: ALE.P03 (DRUG).
Who is sponsoring clinical trial NCT07169734?
This trial is sponsored by Alentis Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07169734 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Kentucky, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07169734's enrollment target sits among peer trials
180 156th of 381 higher than 223 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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