Actively Recruiting
Phase 2 Study of ES014 Treatment for Adults with Desmoid Tumors Open-Label, Multicenter, Single-Arm Clinical Trial
Led by Elpiscience (Suzhou) Biopharma, Ltd. · Updated on 2026-04-30
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the drug ES014 in adults with desmoid tumors in this open-label, multicenter, single-arm phase 2 clinical study. The study aims to assess the effectiveness, safety, tolerability, patient-reported outcomes, pharmacokinetics, pharmacodynamics, and immune response to ES014 in this patient population. Participants will receive ES014 through intravenous infusion at doses of either 700 mg or 1400 mg every 14 days. The study design includes two experimental arms with these dosing regimens. Treatment will be given over a period of 1 to 3 years while monitoring the patients closely for response and side effects. During the study, participants will undergo evaluations including tumor response assessments according to RECIST 1.1 criteria, safety and tolerability checks, pharmacokinetic testing, and immune response measurements. Researchers will track patient-reported outcomes and monitor for adverse effects throughout the study duration. The primary outcome is the objective response rate measured by an independent review committee over 1 to 3 years.
CONDITIONS
Brief Title
A Study in Adults With Desmoid Tumors
Research Team
J
Jiayu Song
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