NCT04891198

ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors

An Open, Single-arm, Multi-center Phase II Clinical Study of ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB uesd comfirmed TMB-H Value

Detailed description

The enrolled subjects will receive envafolimab treatment during the treatment phase, and the dosage and usage is 400 mg envafolimab subcutaneously injected every four weeks, 28 days as a treatment cycle. The study treatment continued to reach the standard of stopping treatment. During this period, the efficacy, safety and PK will be evaluated according to the visit process.In this study, imaging examinations (CT or MRI) were used to evaluate the efficacy at baseline and during the study period. The results of the examination were evaluated based on the efficacy evaluation criteria for solid tumors (RECIST1.1) and irRECIST criteria.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Envafolimab	Subcutaneous injection

Timeline

• Start date: 2021-08-06
• Primary completion: 2027-08-30
• Completion: 2028-04-30
• First posted: 2021-05-18
• Last updated: 2026-03-25

Locations

1 site across 1 country: China