癌研連線CancerLink
Recruiting NCT07107490

A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Lung CancerPhase 1PD-L1

This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.

Conditions: Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.