Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects over 18 years of age. 2. The subject must have a solid tumor confirmed by histology or cytology, and belong to one of the following categories: 1) locally advanced or metastatic SCLC, which has received standard treatment in the past and developed progress or intolerance; 2) Low-grade, medium-grade or high-grade locally advanced or metastatic GEP-NET, who has previously received first-line or multi-line anti-tumor treatment and developed progress or intolerance (unless there is no standard treatment available or such treatment is not suitable); 3) Metastatic or locally advanced unresectable TNBC, which is confirmed by histological examination, is characterized by the lack of expression of human epidermal growth factor 2(HER2), estrogen receptor (ER) and progesterone receptor (PR), and recurs/is refractory after standard treatment or has no standard treatment (which must include paclitaxel chemotherapy). 4) Other locally advanced or metasta