癌研連線CancerLink
招募中 NCT06747585

一項調查ALE.P02作為單一療法在患有選擇性CLDN1 +實體腫瘤的成年患者中的研究

肺癌頭頸癌食道癌Phase IIII 期IV 期Claudin 18.2

本研究的目的是評估安全性、耐受性、藥物動力學、藥效學、初步抗腫瘤活性，並確定ALE.P02單藥治療在患有選定鱗狀實體瘤的成年患者中的推薦II期劑量(RP2D)。

適應症：Squamous Non-small-cell Lung Cancer、Head and Neck Squamous Cell Carcinoma、Cervical Squamous Cell Carcinoma、Esophageal Squamous Cell Carcinoma

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。