Overview
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.
Eligibility
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)