This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the 3 + 3 dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.