drugset / Trial / NCT03758001

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors

NCT03758001

Phase 1 Completed 38 enrolled Innovent Biologics (Suzhou) Co. Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.

Timeline

Start
2019-02-13
Primary completion
2023-02-16
Completion
2023-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject CUDAROLIMAB Monoclonal antibody 0.01 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 0.1 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 0.3 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 1 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 3 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 6 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 10 mg/kg Intravenous
Subject CUDAROLIMAB Monoclonal antibody 15 mg/kg Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications