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

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Seribantumab

• Registration Number: NCT04790695
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-03-29
• Status Verified: 2021-12
• Primary Completion: 2021-12-22
• Study Completion: 2021-12-22
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seribantumab	Seribantumab	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada