extensive stage small cell lung cancer
Conditions
Interventions
ALPS12: intravenous infusion
obinutuzumab: intravenous infusion
Sponsors
Brenden Chen
Eligibility
Sex/Gender
All
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, efficacy, exploratory, phamacokinetics To evaluate the safety and tolerability based on NCI CTCAE v5.0 To evaluate the PK profile of ALPS12 To evaluate the antitumor activity based on RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, exploratory,phamacokinetics To evaluate the safety based on NCI CTCAE v5.0 To evaluate the PK profile of ALPS12 To evaluate the antitumor activity based on RECIST v1.1 | — |
Countries
Australia, Hong Kong, Japan, Taiwan
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed