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Protocol Summary


Protocol No.
PSCI-20-095
Prinicipal Investigator
Ma, Patrick
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
ELVCAP-001-01
Title
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.
Applicable Disease Sites
Lung

Other Gastrointestinal
Status
Open
Participating Institutions
Hershey Medical Center