CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
Objective
Primary: To determine the objective response rate by independent radiologic review to single agent seribantumab (anti-HER3 targeted therapy) in patients with centrally confirmed NRG1 gene fusion positive advanced cancer according to RECIST 1
Secondary: To determine the overall efficacy of single agent seribantumab in NRG1 fusion positive patients with various advanced cancers through the assessment of the following clinical outcome parameters: Duration of Response (DoR) Progression-free Survival (PFS) Overall Survival (OS) Clinical Benefit Rate (CR, PR, SD > 24 weeks) To describe the safety profile of seribantumab in NRG1 gene fusion positive patients.
