drugset / Trial / NCT03545971

A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.

NCT03545971

Phase 1 Completed 53 enrolled Innovent Biologics (Suzhou) Co. Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced melanoma(Ib).

Timeline

Start
2018-09-25
Primary completion
2021-09-10
Completion
2022-08-09

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI310 Monoclonal antibody 0.3 mg/kg Intravenous
Subject IBI310 Monoclonal antibody 1 mg/kg Intravenous
Subject IBI310 Monoclonal antibody 2 mg/kg Intravenous
Subject IBI310 Monoclonal antibody 3 mg/kg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications