Tests ALPS12 in adults with extensive-stage small cell lung cancer
Tests the new drug ALPS12 in adults with advanced small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 1
Where in Hong Kong
- Queen Mary HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chugai Pharmaceutical
- Trial code
- NCT07107490
- Record updated
- 6 February 2026
- Original description
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.Read full original descriptionShow less
AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
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.
Inclusion: 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: 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; Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug; History or complication of clinically significant autoimmune disease; a positive HIV antibody test at screening; Active hepatitis B or hepatitis C; 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); 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; Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study.