Patritumab Deruxtecan for Brain Tumor
(PARAMETer Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if patritumab deruxtecan can reach brain tumor tissue after a single dose before surgery. The focus is on patients with brain metastases from certain solid tumors, such as lung, breast, or prostate cancer. Participants should have surgically removable brain metastases and controlled symptoms without severe brain-related issues. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that patritumab deruxtecan is likely to be safe for humans?
Research has shown that patritumab deruxtecan has been tested in patients with cancer that has spread to the brain. In these studies, the treatment demonstrated noticeable effects in the brain, indicating its efficacy against cancer there. Regarding safety, patients generally tolerated the treatment well, though some experienced side effects such as nausea, tiredness, and a drop in certain blood cells, which are common with many cancer treatments. However, most side effects were manageable and not severe.
This trial is in "Phase 2," meaning earlier studies found the treatment safe enough for people. This phase aims to learn more about the treatment's safety and effectiveness. Overall, patritumab deruxtecan appears to be a promising option for people with brain tumors, with a safety profile acceptable for further testing.12345Why do researchers think this study treatment might be promising for brain tumors?
Unlike the standard treatments for brain tumors, which often include surgery, radiation, and chemotherapy, Patritumab deruxtecan targets a specific protein called HER3. This drug is unique because it combines an antibody that homes in on HER3 with a chemotherapy agent, delivering a potent punch directly to the cancer cells. Researchers are excited because this targeted approach may offer more effective results with potentially fewer side effects than traditional chemotherapy, as it aims to spare healthy cells by focusing on the cancerous ones. Additionally, the drug is administered intravenously and can be given shortly before surgery, which could help shrink tumors quickly and improve surgical outcomes.
What evidence suggests that patritumab deruxtecan might be an effective treatment for brain tumors?
Research shows that patritumab deruxtecan, also known as HER3-DXd, may help treat brain metastases. One study found that patients with brain metastases from breast cancer had stable cancer for about 4 months on average, meaning it did not worsen during this period. Another study found that 55% of patients lived at least 3 months after starting treatment. In this trial, participants with surgically-resectable brain metastases will receive patritumab deruxtecan. These findings suggest that patritumab deruxtecan could be a helpful option for patients with brain tumors, especially when other treatments have not been effective.36789
Who Is on the Research Team?
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of patritumab deruxtecan intravenously before surgery
Surgery and Specimen Collection
Participants undergo craniotomy and resection of brain metastases, with specimen collection including tumor, blood, and cerebrospinal fluid
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse event analysis
What Are the Treatments Tested in This Trial?
Interventions
- Patritumab deruxtecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Lead Sponsor
Daiichi Sankyo
Industry Sponsor
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
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