Tests ALE.P02 alone or with pembrolizumab in squamous solid tumors
Tests ALE.P02, alone or with pembrolizumab, in adults with advanced CLDN1-positive squamous cancers.
Plain-language title generated from the registry record
Registry title: A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Key facts
- Where
- Barcelona, Madrid, Málaga, PAU de Sanchinarro, Pozuelo de Alarcón, Seville, and Valencia, SpainSee the 9 sites
- Phase
- Phase 1/2
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- NEXT Oncology BarcelonaBarcelona, SpainTaking people
- START Hospital HM Nou DelfosBarcelona, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- START Madrid- Centro Integral Oncologico Clara CampalPAU de Sanchinarro, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Hospital Universitario Virgen de la MacarenaSeville, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alentis Therapeutics AG
- Trial code
- NCT06747585EU 2024-515459-39-00
- Record updated
- 28 October 2026
- Original description
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 as a monotherapy or in combination with pembrolizumab in adult patients with selected squamous solid tumors.Read full original descriptionShow less
A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy or in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors
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 as a monotherapy or in combination with pembrolizumab in adult patients with selected squamous solid tumors.
Inclusion: Have disease and treatment history as: 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 Monotherapy 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; Phase I Combination Therapy RDE: Have received no previous systemic therapy in incurable recurrent or metastatic setting; 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: Has received antineoplastic therapies prior to study intervention within specified time frame; Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma; Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain); Patients with uncontrolled diabetes; 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; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.