Actively Recruiting
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Led by Alentis Therapeutics AG · Updated on 2026-03-03
170
Participants Needed
38
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed advanced, locally recurrent inoperable or metastatic squamous non-small-cell lung cancer, head and neck squamous cell carcinoma (including nasopharyngeal cancer), esophageal squamous cell carcinoma, or cervical squamous cell carcinoma.
- Phase I dose escalation participants must have received at least one systemic standard-of-care regimen and be refractory or intolerant to it.
- Phase I recommended dose expansion and Phase II participants may have received no more than two systemic standard-of-care regimens and be refractory or intolerant.
- Have provided tissue samples for Claudin-1 analysis in a central laboratory.
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Demonstrate adequate bone marrow and organ function.
- Have recovered from all toxicities caused by prior treatments.
- Have measurable disease based on RECIST 1.1 criteria as determined by the site.
You will not qualify if you...
- Diagnosed with cancers that are predominantly non-squamous, such as adenosquamous carcinoma or adenocarcinoma.
- Received antineoplastic therapies within a specified time frame before the study intervention.
- Have rapidly progressing disease, including tumor bleeding or uncontrolled tumor pain.
- Have uncontrolled diabetes.
- Have known active central nervous system metastases or carcinomatous meningitis.
- Have clinically significant gastrointestinal bleeding or active infection requiring systemic treatment.
- Have any condition, therapy, or laboratory abnormality that could interfere with the study or patient participation.
- Use drugs that prolong or shorten the QT interval or have a risk of Torsades de Pointes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Mayo Foundation for Medical Education and Research - Mayo Cl
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
The University of Chicago Medical Center - Oncology
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Norton Cancer Institue Downtown
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
10
Centre Georges Francois Leclerc - Oncologie Medicale
Dijon, France, 21079
Actively Recruiting
11
CHRU De Lille- Hôpital Claude Huriez - Medical Oncology
Lille, France, 59000
Actively Recruiting
12
AP-HM Hôpital de La Timone CEPCM
Marseille, France, 13005
Actively Recruiting
13
Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole
Toulouse, France, 31100
Actively Recruiting
14
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
15
Chinese University of Hong Kong - Prince of Wales Hospital
Shatin, N.T., Hong Kong
Actively Recruiting
16
Ospedale San Raffaele, IRCCS
Milan, Italy, 20132
Actively Recruiting
17
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy, 20141
Actively Recruiting
18
Ospedale Santa Maria delle Croci di Ravenna Oncologia
Ravenna, Italy, 48121
Actively Recruiting
19
PU A. Gemelli, Universita Cattolica del Sacro Cuore
Roma, Italy
Actively Recruiting
20
Centro Ricerche Cliniche Verona
Verona, Italy
Actively Recruiting
21
National University Cancer Institue
Singapore, South West, Singapore, 11907
Actively Recruiting
22
National Cancer Centre Singapore
Singapore, South West, Singapore, 168583
Actively Recruiting
23
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
24
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
25
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
26
START Madrid- Centro Integral Oncologico Clara Campal
PAU de Sanchinarro, Madrid, Spain, 28050
Actively Recruiting
27
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
28
NEXT Oncology Barcelona
Barcelona, Spain, 08023
Actively Recruiting
29
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
30
START Hospital HM Nou Delfos
Barcelona, Spain
Actively Recruiting
31
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
32
Hospital Universitario Virgen De La Victoria
Málaga, Spain, 29010
Actively Recruiting
33
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41009
Actively Recruiting
34
Hospital Universitario Y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
35
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan, 50006
Actively Recruiting
36
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan, 500209
Actively Recruiting
37
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
38
Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital
Taipei, Taiwan, 231020
Actively Recruiting
Research Team
A
Alentis Clinical Trial Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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