Background: CS1003 is a novel humanized IgG4 anti-PD-1 monoclonal antibody. In phase 1a dose-escalation, CS1003 showed a well-tolerated safety profile with no dose-limiting toxicity, and a wide therapeutic window at doses up to 10 mg/kg Q3W (maximum administrated dose, MAD) in patients (pts) with solid tumors.Two fixed-dose regimens were explored in the phase Ib portion of this ongoing clinical trial in pts with selected solid tumors. Methods: Pts were enrolled in cohort A (200 mg Q3W) or cohort B (400 mg Q6W) to receive CS1003 intravenously. Safety, preliminary tumor activity (overall response per RECIST v1.1 by investigators) and PK were assessed.
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