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Regorafenib + Envafolimab in KIT Exon 17 Mutated GIST
NCT06772233Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2025
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- Peking University
- Modality
- Nanobodies (VHH), Monoclonal Antibodies
- Drugs
- envafolimab
- Conditions
- gastrointestinal stromal tumor (GIST)
01
Overview
Phase 2, randomised, open-label trial of envafolimab in gastrointestinal stromal tumor (GIST) (2 arms), sponsored by Peking University. Primary endpoint: Progression-Free Survival at 2 years. Planned start Jul 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Regorafenib + Envafolimab
Regorafenib combined with Envafolimab
Physician's Choice
Standard of care TKI therapy based on physician's choice
03
Who it enrols
Adult patients with metastatic GIST harboring KIT exon 17 mutation who have progressed on or are intolerant to imatinib, sunitinib, regorafenib, or ripretinib. Patients must have adequate organ function and no history of immune checkpoint inhibitor therapy.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
Incidence of Treatment-Emergent Adverse Events
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