The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
Signed the informed consent voluntarily and agreed to follow the program requirements
Either sex
Age: ≥18 years
Has a life expectancy of ≥3 months
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 2 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
Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc;
Subjects with prolonged QT interval (QTc >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., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)
Sequential
BL-B01D1
DrugBL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen
Participants with Dose-limiting toxicities
Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: * Grade 4 neutrophil count decreased lasting \>7 days * Grade ≥3 febrile neutropenia * Grade ≥3 platelet count decreased with clinically significant hemorrhage. Non-Hematological toxicities: * Death * Hy's law cases * Grade ≥3 non-hematological toxicities,
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-B01D1
Calculate maximum (peak) observed concentration of BL-B01D1
Cmax of anti-EGFR×HER3 antibody
Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
Cmax of free payload ED-04
Calculate maximum (peak) observed concentration of free payload ED-04
Tmax of BL-B01D1
Calculate time of maximum observed concentration of BL-B01D1
Click on the lead sponsor to view all of their trials.
