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.
Patients with pathologically confirmed locally advanced/unresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced/unresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .
Adequate organ and hematologic function.
At least 1 extracranial measurable lesion.
An ECOG activity status score of 0-1.
Patients with sensitive mutations or gene fusions related to lung cancer.
Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
A history of active autoimmune disease within the past 2 years.
A history of clinically significant cardiovascular disease, severe cardiac rhythm /conduction abnormalities or LVEF <50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
Sequential
BT02
Drugmonoclonal antibody injection with intravenous administration every 2 or 3 weeks
Adverse events
Dose limited toxicity incidence
Maximum tolerated dose(MTD)
Recommended Phase II dose (RP2D)
Objective response rate (ORR) on tumor assessments
Progression-free survival (PFS) on tumor assessments
Overall survival (OS) on tumor assessments
Duration of response (DoR) on tumor assessments
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This trial is not recruiting at the moment. You can still explore other options:
