Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Alentis Therapeutics AG (Voir sur ClinicalTrials)
décembre 2024
août 2028
30 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 23/07/2026 10:15:07 | Contacter | ||
Critères
Tous
- 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.