癌研連線CancerLink
招募中 NCT07169734

一項研究，調查ALE.P03作為單藥治療在選擇晚期或轉移性CLDN1 +實體腫瘤的成年患者中的作用

非小細胞肺癌大腸直腸癌膀胱癌／泌尿道上皮癌膽道癌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.P03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：Cervical Squamous Cell Carcinoma、Squamous Non-small-cell Lung Cancer、Colorectal Cancer、Intrahepatic Cholangiocarcinoma、Urothelial Carcinoma

收案條件

納入條件

  • Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
  • Have documented radiological disease progression at study entry.
  • Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
  • Phase I Dose Escalation:
  • \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
  • Phase I RDE and Phase II:
  • Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
  • Patients with actionable oncogenic drivers: received feasible targeted therapy.
  • Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
  • Measurable disease per RECIST 1.1, as determined by the site.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
  • Demonstrate adequate bone marrow and organ function as per the protocol.

排除條件

  • SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
  • Has received antineoplastic therapies prior to study intervention within specified time frame.
  • Has rapidly progressing disease.
  • Has known active central nervous system metastases and/or carcinomatous meningitis.
  • Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
  • Has clinically significant gastrointestinal bleeding.
  • Has an active infection requiring systemic treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

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。