Generic/working name | Sinitilimab, anti-PD-1-antibody |
Company name | Innovent Biologics (Suzhou) Co. Ltd. |
Drug type | Antibody |
Drug class | Immune therapy |
Dose | 200 milligrams (mg) per flat dose |
Route | IV |
Schedule of administration | Patients with neuroendocrine neoplasms that failed to respond or became intolerant of standard treatment were enrolled to either the Phase Ia dose escalation study to receive sintilimab (a fully humanized anti-PD-1 monoclonal antibody, Innovent), or cohort B (digestive system cancer or neuroendocrine neoplasms) of the phase Ib trial to receive sintilimab 200 mg intravenously every 3 weeks. In phase Ia, “3 + 3” design was used during dose escalation: 1 mg/kg, 3 mg/kg, and 200 mg (1:1 randomization) and 10 mg/kg. After 28 days of dose limiting toxicity (DLT) observation, patients would repeat doses every 3 weeks for 200 mg level and every 2 weeks for the other dose levels. The selected dose for Ib was based on results of phase Ia and preclinical studies. |