definition for: #HopEStrial

TYME and The Joseph Ahmed Foundation Announce Initiation of the HopES Phase II Trial Evaluating the Potential Benefits of SM-88 for Patients with High-Risk Sarcomas. The HopES trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following primary or palliative treatments for Ewing's sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated HopES Phase II trial of SM-88 in patients with previously-treated metastatic sarcomas. The primary objectives are to measure overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST v1.1), and incidence of treatment-emergent adverse events.