癌研連線CancerLink
招募中 NCT07169734

一项研究，调查ALE.P03作为单药治疗在选择晚期或转移性CLDN1 +实体肿瘤的成年患者中的作用

非小细胞肺癌结直肠癌膀胱癌／尿路上皮癌胆道癌Phase IIII 期IV 期Claudin 18.2

本研究的目的是评估安全性、耐受性、药物动力学、药效学、初步抗肿瘤活性，并确定ALE.P03单药治疗在患有选定鳞状实体瘤的成年患者中的推荐II期剂量(RP2D)。

适应症：Cervical Squamous Cell Carcinoma、Squamous Non-small-cell Lung Cancer、Colorectal Cancer、Intrahepatic Cholangiocarcinoma、Urothelial Carcinoma

入组条件

纳入标准

  • 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.

排除标准

  • 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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。