ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This study is an open, single-arm study, without randomization and blindingMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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, t...
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.
Tracking Information
- NCT #
- NCT04891198
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lin Shen, MD Peking Universtiy Cancer Hospital
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