drugset / Trial / NCT04177290

A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

NCT04177290

Phase 1 Completed 48 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment

Timeline

Start
2020-04-02
Primary completion
2021-02-28
Completion
2022-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous