drugset / Trial / NCT04085185

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

NCT04085185

Phase 1 Unknown 268 enrolled Innovent Biologics (Suzhou) Co. Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.

Timeline

Start
2019-12-04
Primary completion
2023-12-15
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NEGALSTOBART Monoclonal antibody 0.01 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 0.1 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 0.3 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 0.7 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 1 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 1.5 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 3 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 5 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 8 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 10 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 20 mg/kg Intravenous
Subject NEGALSTOBART Monoclonal antibody 200 mg Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications