A Phase I/II, Multicenter, Open-label, Single-arm, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 Sequential Therapy in Adult Subjects With Advanced Solid Tumors (Including Gastroenteropancreatic Neuroendocrine Neoplasms, Small Cell Lung Cancer or Triple Negative Breast Cancer)
This is a multicenter, open-label, single-arm, dose-escalation and dose-expansion Phase I/II study to evaluate the safety, tolerability and preliminary anti-tumor activity of MB0151 in adult subjects (at least 18 years old) with advanced solid tumors. This study includes two phases: dose escalation and dose expansion. In this study, the protocol of accelerated titration combined with i3+3 is used for dose escalation,administered intravenously every 2 weeks. Enrolled subjects will be sequentially assigned to the planned dose cohorts according to this protocol to receive MB0151 treatment and will be monitored for the occurrence of DLT. The RP2D and/or OBD will be determined by considering the PK profile, safety and efficacy data in the dose-escalation stage (including backfill cohorts).
• Male or female subjects aged ≥18 years.
• Subjects must have locally advanced or metastatic solid tumors confirmed by histology or cytology, which have failed or are intolerant of standard treatment.
• ECOG PS is 0-1.
• Life expectancy ≥3 months.
• normal organ function, defined as follows:Bone marrow (not treated with blood transfusion or hematopoietic stimulating factor within 14 days): Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 90 g/L.Liver: total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3×ULN (if accompanied by liver metastasis, ≤5×ULN).Kidney: Serum creatinine concentration ≤1.5×ULN.Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5× ULN; International normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN.
• Requirements for the detection of biomarkers: For the dose escalation and backfill cohort in the Phase I study, biomarkers are not detected when they are selected; For phase II study, biomarkers were detected by IHC in the central laboratory at baseline.
• According to RECIST version 1.1, there is at least one target lesion.
• Male or female subjects who are infertile, not in pregnancy or agree to use at least one effective contraceptive method during the study intervention period (from 14 days before the first administration to at least 180 days after the last administration of the study intervention).
• An informed consent form (ICF) that can be understood and signed, including compliance with ICF and the requirements and restrictions listed in this plan.