癌研連線CancerLink
招募中 NCT07107490

ALPS12用于广泛期小细胞肺癌患者的第一期研究

肺癌Phase IPD-L1

本研究是一项第一期、开放标签、多中心试验，旨在评估ALPS12用于广泛期小细胞肺癌患者的安全性、耐受性、药物动力学、免疫原性及抗肿瘤活性。研究分为两部分：剂量递增部分及扩展部分。

适应症：Extensive Stage Small Cell Lung Cancer

入组条件

纳入标准

  • Aged \>18 years at time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • Histologically documented extensive stage small cell lung cancer
  • Disease recurrence documented after at least one prior systemic therapy.
  • Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
  • Measurable disease per RECIST v.1.1.
  • Adequate hematologic and end organ function

排除标准

  • Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
  • History or complication of clinically significant autoimmune disease
  • a positive HIV antibody test at screening
  • Active hepatitis B or hepatitis C
  • Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
  • Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
  • History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
  • Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
  • Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
  • History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
  • Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)

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。