| Description |
This is an exploratory clinical trial of BJ-001, including phase Ia trial and Phase Ib trial, both of which are open trials. Subjects will be screened after signing the informed consent form (-28 days ~ -1 days), and qualified subjects will be administered according to the visit plan shown in the flow chart (subcutaneous injection of BJ-001; The drug was administered once every 2 weeks, and every 4 weeks was a course of treatment. Safety assessment (continued until 28 days after the last administration or the patient started other anti-cancer treatments, whichever was the first), efficacy assessment, PK blood collection, immunogenicity sampling, PD sampling, etc., were conducted until the subjects met the criteria for ending the administration. CTCAE v5.0 was used to grade the AE, and RECIST v1.1 and iRECIST were used to evaluate the tumor. |
