drugset / Trial / NCT04182789

KN035 in Patients With Advanced Multiple Primary Tumors

NCT04182789

Phase 2 Unknown 20 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, single arm, single center exploratory clinical research, to evaluate KN035 late treatment in patients with Multiple Primary tumors (MPC, Multiple Primary working) clinical benefit.In the study, all subjects meeting the criteria for inclusion will be enrolled in the KN035 treatment group, and patients cannot receive any other anti-tumor treatment during the study period.The primary endpoint of the study was defined as patients who could be assessed by imaging, and the optimal Objective Response Rate (ORR) based on RECIST 1.1 standard, while the secondary endpoint was safety (nci-ctcae 4.0), DCR (Disease Control Rate), DoR (Duration of Response), progression-free survival (PFS),1) Overall Survival and Overall Survival;The end point of the exploratory study was the correlation between different molecular types and the efficacy of immunotherapy.

Timeline

Start
2019-03-26
Primary completion
2021-02
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 150 mg Subcutaneous

Indications

No indication recorded.