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

Korábbi kezelés

• 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

Más betegség

• 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)

Laborértékek

• 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

Egyéb

• Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study

• 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