Patritumab Deruxtecan for Brain Tumor
(PARAMETer Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMustafa Khasraw, MBChB, MD, FRCP, FRACP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing if a targeted cancer drug called patritumab deruxtecan can reach brain tumors in patients whose cancer has spread to the brain. The drug works by using an antibody to deliver chemotherapy directly to the cancer cells. Patients will receive the drug before surgery to see how well it works and if it is safe.

Eligibility Criteria

This trial is for adults with new or returning brain tumors that can be removed by surgery. They should have minimal symptoms, agree to a craniotomy, and use birth control if needed. Eligible cancers include melanoma, stomach, breast, colorectal, bladder, ovarian cancer etc., with good performance status and organ function.

Inclusion Criteria

I am 18 years old or older.

I am willing and able to undergo brain surgery.

I am mostly able to care for myself.

+7 more

Exclusion Criteria

Participants with an impending, life-threatening cerebral herniation syndrome

I do not have major heart problems before starting the treatment.

Subjects with human immunodeficiency virus (HIV) infection

+7 more

Participant Groups

The study tests patritumab deruxtecan (HER3-DXd) in patients before they undergo brain tumor removal surgery. It aims to see if the drug reaches the brain tissue after one dose.

1Treatment groups

Experimental Treatment

Group I: Patritumab deruxtecanExperimental Treatment1 Intervention

15 participants with surgically-resectable brain metastases from multiple solid tumor primary histologies known to express HER3 will be treated. Patritumab deruxtecan (HER3-DXd) will be administered IV 5.6 mg/kg as a single dose 1-3 days prior to planned craniotomy and resection of BrM. Participants will undergo specimen collection prior to and during the planned craniotomy, including tumor, blood, and cerebrospinal fluid (CSF).