The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
monoclonal antibody injection with intravenous administration every 2 or 3 weeks
Adverse events
Time frame: through study completion, an average of 2 years
Dose limited toxicity incidence
Time frame: Through the dose escalation phase , an average of 8 months
Maximum tolerated dose(MTD)
Time frame: Through the dose escalation phase, an average of 8 months
Recommended Phase II dose (RP2D)
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Progression-free survival (PFS) on tumor assessments
Time frame: Through the study completion,an average of 2 years
Overall survival (OS) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Duration of response (DoR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Disease control rate (DCR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level
Time frame: Through study completion, an average of 2 years
Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level
Time frame: Through study completion, an average of 2 years
ADA and NAb incidence
Time frame: Through the study completion, an average of 2 years
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