A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.

"Stage 1:~Six dose groups of 2, 5, 10, 15, 20 and 40 mg/kg were planned. Dose increments began at 2 mg/kg using accelerated titration. In the first dose group, after the first patient was injected with Sibp-03, if the subject developed toxicity grade ≥2（CTCAE v5.0 standard）within 21 days of initial administration，then the subject increased to 3 and the study design method in this dose level convert to 3+3. If the subject didn't develop toxicity grade ≥2, then the study of the second and next dose group can be carried out using 3+3 incremental design.~Stage 2:~Cohort 1 included patients with advanced head and neck squamous cell carcinoma and cohort 2 included patients with breast cancer. According to the results of dose escalation stage and similar drug trials, 5mg/kg and 10mg/kg dose levels were selected to enter this phase. Each cohort will be extended to include 6-8 subjects to receive this product in combination with the standard treatment study."