The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
Signed the informed consent form voluntarily and agreed to follow the program requirements
Age: ≥18 years
Has a life expectancy of ≥3 months
Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy.
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, 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; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment
Subjects with prolonged QT interval corrected ([QTcF] >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc. Subjects with well-controlled type 1 diabetes, hypothyroidism, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis) are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening
Sequential
BL-M05D1
DrugBL-M05D1 will be administered on D1 every 3 weeks.
Participants with Dose-limiting toxicities
A DLT is defined as the following: Toxicity that results in a \>14-day delay in treatment \- Hematologic toxicities 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 \- Nonhematologic toxicities Death not clearly related to disease progression or extraneous cause Hy's law cases Grade ≥3 nonhematologic toxicities, except for: Grade 3 nausea/vomiting or diarrhea for less than 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
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Participants with abnormal physical examination findings
Measure the number of participants with abnormal physical examination findings.
Participants with ability to care for themselves, daily activity, and physical activity
Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)
Cmax of BL-M05D1
Calculate maximum (peak) observed concentration of BL-M05D1
Cmax of anti-BL-M05D1 antibodies
Calculate maximum (peak) observed concentration of anti-BL-M05D1 antibodies
Cmax of free payload ED-04
Calculate maximum (peak) observed concentration of free payload ED-04
Tmax of BL-M05D1
Calculate time of maximum observed concentration of BL-M05D1
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