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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Seribantumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04790695

TOHCC-OLIP-01

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Seribantumab

Experimental group

Description:

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.

Treatment:

Drug: Seribantumab