Trials / Completed
CompletedNCT04790695
Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2021-03-29
- Primary completion
- 2021-12-22
- Completion
- 2021-12-22
- First posted
- 2021-03-10
- Last updated
- 2022-01-12
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04790695. Inclusion in this directory is not an endorsement.