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NCT04790695 Clinical Trial

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

Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04790695
Other study ID # TOHCC-OLIP-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 29, 2021
Est. completion date December 22, 2021

Study information
Verified date December 2021
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 22, 2021
Est. primary completion date December 22, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada The Ottawa Hospital Cancer Centre Ottawa Ontario

Sponsors (1)
Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 1 year
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