Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab

Ottawa Hospital Research Institute1 enrolled

Overview

NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation. Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits NRG1-dependent activation and HER2 dimerization.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Cancer

Interventions

SeribantumabDRUG

For the induction phase: Seribantumab 3,000 mg IV weekly for 12 weeks then Maintenance Phase: Seribantumab 3,000 mg IV infusion once every 2 weeks, initiating approximately 14 days after completion of induction phase. Dose or schedule may be adjusted at the discretion of the treating physician.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Serious, life-threatening condition * Not eligible for, or exhausted all other treatment options or causing significant toxicity * No other way to access treatment Exclusion Criteria: \-

Locations (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Overall survival

Time frame: 1 year

Data from ClinicalTrials.gov

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