Actively Recruiting
A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Led by Alentis Therapeutics AG · Updated on 2026-03-19
180
Participants Needed
28
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALE.P03 as a monotherapy in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) solid tumors, including colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. This Phase I/II open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of ALE.P03. Participants will receive ALE.P03 through intravenous infusion. The study includes a Phase I dose escalation to find the maximum tolerated dose and a safe recommended dose for expansion (RDE). Following this, the Phase I dose expansion will identify the recommended Phase II dose. In Phase II, ALE.P03 will be given at the RP2D or per the dosing schedule determined after dose expansion. During the study, researchers will monitor patients for dose limiting toxicities, adverse events, overall response rate, and duration of response for up to four years. Blood samples will be collected to measure drug concentrations and immune response markers. Additional assessments include disease control rate, progression-free survival, and overall survival at various time points. Safety follow-up will continue for 30 days post last dose, with long-term monitoring as part of the study.
CONDITIONS
Brief Title
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically and cytologically confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, or cervical squamous cell carcinoma
- Documented radiological disease progression at study entry
- Provided tissue for Claudin-1 (CLDN1) analysis in a central laboratory
- Phase I dose escalation participants must have received and be refractory or intolerant to standard systemic treatments for advanced disease
- Phase I RDE and Phase II participants must have received 1-2 standard systemic treatments and be refractory or intolerant
- Patients with actionable oncogenic drivers must have received feasible targeted therapy
- Measurable disease per RECIST 1.1 as determined by the site
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function according to protocol
You will not qualify if you...
- Patients with squamous non-small cell lung cancer or cervical squamous cell carcinoma diagnosed with predominantly non-squamous histology or adenocarcinoma
- Received antineoplastic therapies prior to study intervention within specified time frames
- Rapidly progressing disease
- Known active central nervous system metastases or carcinomatous meningitis
- History of interstitial lung disease or pneumonitis requiring steroids, or current symptomatic pneumonitis needing steroids or immunosuppressants
- Clinically significant gastrointestinal bleeding
- Active infection requiring systemic treatment
- Any condition, therapy, or laboratory abnormality that might affect study results
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) for screening and enrollment
Duration - Up to 4 years or until disease progression, unacceptable toxicity, or study completion
Participants receive ALE.P03 as monotherapy via intravenous infusion at doses determined by the study phase. The treatment includes dose escalation to establish the maximum tolerated dose, dose expansion to identify the recommended Phase II dose, and Phase II treatment at the recommended dose.
Regular visits for IV infusions and assessments according to assigned phase and dosing schedule
Duration - 30 ± 5 days post last dose, with additional long-term monitoring up to 4 years
Participants are monitored for safety and disease status after treatment completion, including assessment of adverse events and overall response.
Periodic follow-up visits post-treatment
Trial Site Locations
Total: 28 locations
1
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Next Oncology-Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
8
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Institut Gustave Roussy (IGR)
Villejuif, France, 94800
Actively Recruiting
10
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK)
Hong Kong, Hong-Kong, Hong Kong
Actively Recruiting
11
Ospedale San Raffaele, IRCCS - Oncologia Medica
Milan, Italy, 20132
Actively Recruiting
12
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
13
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy, 20141
Actively Recruiting
14
Radboudumc - Centrum voor Oncologie
Nijmegen, Netherlands, 6525
Actively Recruiting
15
National University Hospital (NUH) - Medical Oncology
Singapore, Singapore, 119074
Actively Recruiting
16
National Cancer Centre Singapore (NCCS)
Singapore, Singapore, 168583
Actively Recruiting
17
Hospital HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
18
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
19
See outside Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
20
Virgen of Arrixaca University Clinical Hospital
El Palmar, Spain, 30120
Actively Recruiting
21
Ramón y Cajal Hospital
Madrid, Spain, 28034
Actively Recruiting
22
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
23
HM Sanchinarro University Hospital
Madrid, Spain, 28050
Actively Recruiting
24
University Hospital Quironsalud Madrid
Madrid, Spain, 28223
Actively Recruiting
25
Hospital universitario virgen macarena
Seville, Spain, 41009
Actively Recruiting
26
San Juan de Reus University Hospital
Tarragona, Spain, 43204
Actively Recruiting
27
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
28
La Fe University and Polytechnic Hospital
Valencia, Spain, 46026
Actively Recruiting
Research Team
A
Alentis Clinical Trial Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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