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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04790695

Collaborator

(none)

Enrollment

Location

Arm

8.8

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Cancer	Drug: Seribantumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 29, 2021

Actual Primary Completion Date :

Dec 22, 2021

Actual Study Completion Date :

Dec 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Seribantumab

Outcome Measures

Primary Outcome Measures

Overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT04790695

Other Study ID Numbers:

TOHCC-OLIP-01

First Posted:

Mar 10, 2021

Last Update Posted:

Jan 12, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 12, 2022