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.
- 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?
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 remove 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.
- 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 remove 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
INSTITUTIONAL APPROVAL SIGNOFF