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KN035 in Patients With Advanced Multiple Primary Tumors

NCT04182789 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-02

No results posted yet for this study

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.

Conditions

  • Multiple Primary Neoplasm

Interventions

DRUG

KN035

KN035150mg，once a week, subcutaneously. Every 28 days is a treatment cycle.KN035 can be used for up to 2 years.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2021-02-28
Completion
2021-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182789 on ClinicalTrials.gov