Actively Recruiting
Phase I/II Study of ALE.P02 Monotherapy in Adults With Selected Advanced or Metastatic Claudin-1 Positive Squamous Solid Tumors
Led by Alentis Therapeutics AG · Updated on 2026-03-03
170
Participants Needed
38
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety, tolerability, and preliminary anti-tumor effects of ALE.P02 monotherapy in adults with selected advanced or metastatic squamous solid tumors that express Claudin-1 (CLDN1). The study includes both Phase I and Phase II components to evaluate dosing and effectiveness in treating these cancers. Patients will receive ALE.P02 through intravenous infusion. In Phase I, doses will be gradually increased to find the maximum tolerated dose and a safe dose for further study. The recommended dose from Phase I will be used in Phase II to further evaluate treatment effects. The treatment is given as monotherapy, meaning ALE.P02 is the only drug administered. Participants will undergo assessments including tumor measurements by RECIST 1.1 criteria, blood tests to monitor drug levels and immune response, and evaluations of adverse events and dose-limiting toxicities. Monitoring will continue up to 3.5 years from treatment start. The primary outcomes include response rates and duration of response, with secondary outcomes evaluating disease control, survival times, and detailed pharmacokinetic data.
CONDITIONS
Brief 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...
- Adults 18 years or older
- Diagnosed with 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
- For Phase I dose escalation: received at least one standard systemic treatment and are refractory or intolerant
- For Phase I dose expansion and Phase II: received no more than two lines of standard systemic treatment and are refractory or intolerant
- Provided tissue sample for Claudin-1 analysis
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
- Adequate bone marrow and organ function
- Recovered from prior treatment toxicities
- Have measurable disease as assessed by RECIST 1.1
You will not qualify if you...
- Diagnosed with cancers of mainly non-squamous types or adenocarcinoma
- Received antineoplastic therapies within a restricted time before study treatment
- Have rapidly progressing disease such as tumor bleeding or uncontrolled tumor pain
- Have uncontrolled diabetes
- Have active central nervous system metastases or carcinomatous meningitis
- Have significant gastrointestinal bleeding or active infections requiring systemic treatment
- Have conditions or therapies that could interfere with study participation or data
- Use drugs known to affect heart rhythm by prolonging or shortening the QT interval or causing Torsades de Pointes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3.5 years or until disease progression or study completion
Participants receive ALE.P02 monotherapy via intravenous infusion. Treatment includes a Phase I dose escalation to determine the maximum tolerated dose and recommended dose for expansion, followed by Phase I dose expansion and Phase II treatment at the recommended Phase II dose.
Regular intravenous infusion visits according to assigned dosing schedule
Duration - Approximately 30 ± 5 days post last dose
Participants are monitored for safety and treatment outcomes after the last dose of ALE.P02, including adverse events and overall response assessments.
1 follow-up visit (in-person)
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
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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