This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGmaximal tolerance dose (MTD) of Oba01
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Time frame: DLT will be evaluated on 21 days of observation period
Overall response rate(ORR)
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Time frame: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the date of first dose to the first researcher's evaluation of disease progression or death.
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of first dose to death.
Time frame: Up to approximately 2 years
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