A window of opportunity study of Patritumab Deruxtecan in patients with brain metastases

Purpose of this Study

We are doing this study to find out if the study drug, patritumab deruxtecan, can be measured in brain tumor tissue after a single dose is given before surgery to remove brain metastases.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are newly diagnosed with brain metastases, or have recurrent brain metastases, in which one of the metastases can be removed surgically
  • Are willing and eligible for craniotomy (surgery to temporarily remove a part of the bone of the skull in order to access the brain)
  • Are not pregnant or breast feeding
  • Have not received the study drug (patritumab deruxtecan) before
  • Have not taken medicines that affect your immune system within the past 3 months
  • Do not take a high dose of a steroid medication such as prednisone
  • Do not have active Hepatitis B and/or Hepatitis C infection or HIV
For more information about who can be in this study, please contact the study team at 919-684-5301.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you chose to join this study, you will:
  • Have physical exams
  • Have blood draws and give urine samples
  • Have imaging scans (MRI)
  • Have an electrocardiogram
  • Have lumbar punctures
You will receive a single dose of the study drug before your surgery to remove your brain metastasis. The study drug is given intravenously (IV) through a vein in your arm. If you consent to the optional additional removal of any extracranial metastasis (metastasis located on tissue outside of the brain), you will have surgery to remove that metastasis within 3 days of having your brain metastasis removed. Your final study visit will be about 40 days after you received the study drug.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

Study Details

Full Title

PARAMETer: A window of opportunity study of Patritumab Deruxtecan in patients with brain metastases

Principal Investigator

Mustafa
Khasraw

Protocol Number

PRO00109490

NCT ID

NCT05620914

Phase

I

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov