An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients.
• 1\) Histologically confirmed desmoid tumor.
• 2)Within 12 months prior to enrollment, meeting any of the following: Tumor target lesion growth ≥ 20% or appearance of new lesions;Desmoid tumor-related pain not adequately controlled by non-opioid medications.
• 3)Meeting any of the following conditions: Subjects with recurrence or disease progression after at least one line of treatment (including surgery, radiotherapy, or systemic therapy, etc.); Treatment-naive subjects who are deemed suitable for the study drug by the investigator.
• 4)Presence of at least one measurable lesion (according to RECIST v1.1).
• 5)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
• 6)Life expectancy of at least 12 weeks.
• 7)Adequate hematologic, hepatic, renal and coagulation functions per protocol.
• 8)Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.