Patritumab Deruxtecan for Brain Tumor

(PARAMETer Trial)

Overseen By Mustafa Khasraw, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Chloroquine, Hydroxychloroquine, Corticosteroids

Disqualifiers: Pregnancy, Severe heart disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1-3 days

15 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, there are specific 'washout' periods for certain treatments, like chemotherapy and monoclonal antibodies, before starting the study drug. It's best to discuss your current medications with the study team to understand any necessary adjustments.

How is the drug Patritumab Deruxtecan unique for treating brain tumors?

Patritumab Deruxtecan is unique because it is an antibody-drug conjugate, which means it combines a targeted antibody with a chemotherapy drug, allowing it to specifically target and deliver the chemotherapy directly to cancer cells, potentially reducing side effects compared to traditional chemotherapy. ^{1 2 3 4 5}

Research Team

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Principal Investigator

Duke University

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-3 days

1 visit (in-person)

Treatment

Participants receive a single dose of patritumab deruxtecan intravenously before surgery

1-3 days

1 visit (in-person)

Surgery and Specimen Collection

Participants undergo craniotomy and resection of brain metastases, with specimen collection including tumor, blood, and cerebrospinal fluid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event analysis

40 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Patritumab deruxtecan

Trial Overview 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.

Participant Groups

Group I: Patritumab deruxtecan Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Lead Sponsor

Trials

4

Recruited

120+

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Industry Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

References

1. United States pubmed.ncbi.nlm.nih.gov

Alternative chemotherapeutic agents: nitrosoureas, cisplatin, irinotecan. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Vascular normalization in orthotopic glioblastoma following intravenous treatment with lipid-based nanoparticulate formulations of irinotecan (Irinophore C™), doxorubicin (Caelyx®) or vincristine. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Bevacizumab in recurrent high-grade pediatric gliomas. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bevacizumab and irinotecan treatment for progressive diffuse brainstem glioma: case report. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Bevacizumab and irinotecan in recurrent malignant glioma, a single institution experience. [2019]