The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.
Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.
Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.
Has adequate organ function before enrollment
Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).
Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.
Participants with history of severe heart disease within 6 months before enrollment.
Sequential
SI-B036
DrugSI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks
Participants with Dose-Limiting Toxicities
A DLT is defined as any of the following: * Grade 4 neutrophil count decreased lasting \>7 days. * Grade ≥3 febrile neutropenia of any duration. * Grade ≥3 platelet count decreased with clinically significant hemorrhage. * Grade 4 thrombocytopenia lasting \>72 hours * Death not related to disease progression or extraneous cause. * Hy's law cases * Grade ≥3 infusion-related reactions (IRRs) leading to permanent discontinuation * Grade ≥3 non-hematologic toxicities, except for: * Grade 3 nausea/vomiting or diarrhea for \<72 hours with adequate antiemetic and other supportive care; * Grade 3 fatigue for less than 1 week; * Grade ≥3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions; * Grade ≥3 amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis and does not require hospitalization
Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Measuring the number of patients with serious adverse events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)
Participants with abnormal physical examination findings
Measure the number of participants with abnormal physical examination findings.
Participants with abnormal lab results
Measure the number of participants with abnormal clinical laboratory values
Cmax of SI-B036
Calculate maximum (peak) observed concentration of SI-B036
Cmax of anti-drug antibodies (ADAs) to SI-B036
Calculate maximum (peak) observed concentration of anti-SI-B036 antibodies
Tmax of SI-B036
Calculate time of maximum observed concentration of SI-B036
Tmax of anti-SI-B036 antibodies
Calculate time of maximum observed concentration of anti-SI-B036 antibodies
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