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KN035 Monotherapy in Advanced dMMR/MSI-H Solid Tumors
NCT03667170Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2018
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- 3D Medicines Inc.
- Modality
- Nanobodies (VHH), Monoclonal Antibodies
- Drugs
- envafolimab
- Conditions
- solid tumorcolorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of envafolimab in solid tumor and colorectal cancer (CRC), sponsored by 3D Medicines Inc. Primary endpoint: Objective Response Rate at 2 years. Started Aug 2018; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Subjects with MSI-H/dMMR
patients receive 600 mg of the KN035 Subcutaneously every 3 weeks
03
Who it enrols
Patients with previously treated, locally advanced or metastatic dMMR or MSI-H solid tumors (including colorectal cancer), ECOG 0-1, life expectancy >12 weeks, and no prior immune checkpoint therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Objective Response Rate
Disease Control Rate
Duration of Response
Progression-Free Survival
Overall Survival
Assessment of the safety of KN035
Assessment of the tolerability of KN035
Plasma Concentration of KN035
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