A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
Recruiting · NCT06747585 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ALE.P02
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
41 locations listed across 7 US states.
- Mayo Foundation for Medical Education and Research - Mayo Cl - Scottsdale, Arizona, United States
- Providence Medical Foundation - Fullerton, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Yale Comprehensive Cancer Center - New Haven, Connecticut, United States
- The University of Chicago Medical Center - Oncology - Chicago, Illinois, United States
- Norton Cancer Institue Downtown - Louisville, Kentucky, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- NEXT Oncology Virginia - Fairfax, Virginia, United States
- NEXT Oncology Barcelona - Barcelona, Spain
- Hospital Universitari Vall D Hebron - Barcelona, Spain
- START Hospital HM Nou Delfos - Barcelona, Spain
- Institut Bergonie - Bordeaux, France
- Changhua Christian Medical Foundation Changhua Christian Hospital - Changhua, Taiwan
- Changhua Christian Medical Foundation Changhua Christian Hospital - Changhua, Taiwan
- Centre Georges Francois Leclerc - Oncologie Medicale - Dijon, France
- National Cancer Center - Goyang-si, South Korea
- CHRU De Lille- Hôpital Claude Huriez - Medical Oncology - Lille, France
- Hospital Universitario 12 de Octubre - Madrid, Spain
- AP-HM Hôpital de La Timone CEPCM - Marseille, France
- Istituto Clinico Humanitas - Milan, Italy
- Ospedale San Raffaele, IRCCS - Milan, Italy
- Istituto Nazionale del Tumori, Fondazione IRCCS - Milan, Italy
- IEO - Istituto Europeo di Oncologia, IRCCS - Milan, Italy
- Hospital Universitario Virgen De La Victoria - Málaga, Spain
- Ospedale Santa Maria delle Croci di Ravenna Oncologia - Ravenna, Italy
- PU A. Gemelli, Universita Cattolica del Sacro Cuore - Roma, Italy
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
- Asan Medical Center - Oncology - Seoul, South Korea
- Hospital Universitario Virgen De La Macarena - Seville, Spain
- National Taiwan University Hospital - Taipei, Taiwan
- Buddihist Tzu Chi Medical Foundation - Taipei Tzu Chi Hospital - Taipei, Taiwan
- Centre Hospitalier Universitaire (CHU) de Toulouse - IUCT Oncopole - Toulouse, France
- Hospital Universitario Y Politécnico La Fe - Valencia, Spain
- Centro Ricerche Cliniche Verona - Verona, Italy
- Institut Gustave Roussy - Villejuif, France
- START Madrid- Centro Integral Oncologico Clara Campal - PAU de Sanchinarro, Madrid, Spain
- Hospital Universitario Quironsalud Madrid - Pozuelo de Alarcón, Madrid, Spain
- Chinese University of Hong Kong - Prince of Wales Hospital - Shatin, N.T., Hong Kong
- National University Cancer Institue - Singapore, South West, Singapore
- National Cancer Centre Singapore - Singapore, South West, Singapore