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Recruiting

A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

NCT06747585 · Alentis Therapeutics AG
In plain English

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Official title
A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors
About this study
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.
Eligibility criteria
Inclusion Criteria: * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC. * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * Have provided tissue for CLDN1 analysis in a central laboratory. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. * Demonstrate adequate bone marrow and organ function. * Patients must have recovered from all toxicities led by prior treatment. * Have measurable disease based on RECIST 1.1 as determined by the site. Exclusion Criteria: * Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma. * Has received antineoplastic therapies prior to study intervention within specified time frame. * Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain). * Patients with uncontrolled diabetes. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate. * Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
Study design
Enrollment target: 170 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-16
Estimated completion: 2028-08-15
Last updated: 2026-06-29
Interventions
Drug: ALE.P02
Primary outcomes
  • Number of Patients with Dose Limiting Toxicities (DLTs) (Up to 28 days)
  • Number of Patients with Adverse Events (Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 years]))
  • Overall Response Rate (ORR) (Phase I) (From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years))
Sponsor
Alentis Therapeutics AG · industry
Contacts & investigators
ContactAlentis Clinical Trial Contact · contact · patientinfo@alentis.ch · +41782304288
All locations (41)
Mayo Foundation for Medical Education and Research - Mayo ClRecruiting
Scottsdale, Arizona, United States
Providence Medical FoundationRecruiting
Fullerton, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Yale Comprehensive Cancer CenterRecruiting
New Haven, Connecticut, United States
The University of Chicago Medical Center - OncologyRecruiting
Chicago, Illinois, United States
Norton Cancer Institue DowntownRecruiting
Louisville, Kentucky, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States
Institut BergonieRecruiting
Bordeaux, France
Centre Georges Francois Leclerc - Oncologie MedicaleRecruiting
Dijon, France
CHRU De Lille- Hôpital Claude Huriez - Medical OncologyRecruiting
Lille, France
AP-HM Hôpital de La Timone CEPCMRecruiting
Marseille, France
Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT OncopoleRecruiting
Toulouse, France
Institut Gustave RoussyRecruiting
Villejuif, France
Chinese University of Hong Kong - Prince of Wales HospitalRecruiting
Shatin, N.T., Hong Kong
Istituto Clinico HumanitasRecruiting
Milan, Italy
Ospedale San Raffaele, IRCCSRecruiting
Milan, Italy
Istituto Nazionale del Tumori, Fondazione IRCCSRecruiting
Milan, Italy
IEO - Istituto Europeo di Oncologia, IRCCSRecruiting
Milan, Italy
Ospedale Santa Maria delle Croci di Ravenna OncologiaRecruiting
Ravenna, Italy
PU A. Gemelli, Universita Cattolica del Sacro CuoreRecruiting
Roma, Italy
Centro Ricerche Cliniche VeronaRecruiting
Verona, Italy
National University Cancer InstitueRecruiting
Singapore, South West, Singapore
National Cancer Centre SingaporeRecruiting
Singapore, South West, Singapore
National Cancer CenterRecruiting
Goyang-si, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center - OncologyRecruiting
Seoul, South Korea
START Madrid- Centro Integral Oncologico Clara CampalRecruiting
PAU de Sanchinarro, Madrid, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
NEXT Oncology BarcelonaRecruiting
Barcelona, Spain
Hospital Universitari Vall D HebronRecruiting
Barcelona, Spain
START Hospital HM Nou DelfosRecruiting
Barcelona, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario Virgen De La VictoriaRecruiting
Málaga, Spain
Hospital Universitario Virgen De La MacarenaRecruiting
Seville, Spain
Hospital Universitario Y Politécnico La FeRecruiting
Valencia, Spain
Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
Changhua, Taiwan
Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
Changhua, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi HospitalRecruiting
Taipei, Taiwan
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors · TrialPath