90Y-NM600 for Metastatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with metastatic cancer, aiming to determine if adding a radioactive imaging agent (Y-NM600) can enhance the effectiveness of current cancer drugs and identify the optimal dose. The trial targets those whose cancer continues to spread despite receiving specific immune therapies like Keytruda or Opdivo. Suitable candidates include individuals with metastatic cancers such as lung, liver, or bladder cancer, who have experienced cancer progression on recent scans but are still undergoing their current cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
You can continue taking your current anti-PD-1 or anti-PD-L1 therapy, as well as Ipilimumab or Tremelimumab, during the trial. However, you must stop taking any strong inducers or inhibitors of CYP450 enzymes or drug transporters at least 30 days before the trial and throughout its duration.
Is there any evidence suggesting that 90Y-NM600 is likely to be safe for humans?
Research has shown that 90Y-NM600 has been tested in animals, specifically mice, with promising results. In these studies, mice with certain types of tumors treated with 90Y-NM600 experienced tumor shrinkage and lived longer. Importantly, no major safety concerns emerged in these animal studies.
However, this trial is in an early stage, meaning limited information exists about human reactions to the treatment. Early-stage trials like this one focus on determining the right dose and assessing safety for humans. Since 90Y-NM600 is not yet approved for human use, participants will help researchers learn about its safety in humans.
Considering joining the trial offers a chance to contribute to important research while being closely monitored by a medical team. They will watch for any side effects and adjust the treatment if needed.12345Why are researchers excited about this trial's treatment?
Researchers are excited about 90Y-NM600 for metastatic cancer because it employs a novel approach using a radioactive isotope, yttrium-90, that targets cancer cells more precisely. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, 90Y-NM600 is designed to deliver radiation directly to tumors, potentially reducing side effects. The treatment also offers flexibility in dosing, with different levels being tested to find the most effective and safe dose. This targeted radiotherapy could lead to better outcomes for patients with metastatic cancer by focusing on the disease more accurately and reducing harm to healthy tissues.
What evidence suggests that 90Y-NM600 could be an effective treatment for metastatic cancer?
Research has shown that 90Y-NM600 can be effective against certain tumors. In studies with mice, this treatment stopped tumors from growing and increased survival, particularly in a type of non-Hodgkin lymphoma called T-cell NHL. It even showed potential for long-term remission, suggesting the body might learn to fight the cancer independently. The treatment targets cancer cells with radiation, making the tumor environment less suitable for growth. Although results in prostate cancer were less encouraging, the treatment might still aid patients receiving immunotherapy by boosting their immune system's response to tumors. Participants in this trial will receive different dosages of 90Y-NM600 to evaluate its safety and effectiveness.12567
Who Is on the Research Team?
Grace Blitzer, MD
Principal Investigator
UW Carbone Cancer Center
Justine Bruce, MD
Principal Investigator
UW Carbone Cancer Center
Zachary Morris, PhD
Principal Investigator
UW Carbone Cancer Center
Paul Harari, MD
Principal Investigator
UW Carbone Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with metastatic cancer who are currently being treated with anti-PD-1 or anti-PD-L1 therapies. The study aims to include up to 60 participants, and they will be part of the trial for as long as 9 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1A: Dose Finding
Participants receive escalating doses of 90Y-NM600 to determine the optimal dose
Phase 1B: Expansion Cohort
Participants receive single or multiple doses of 90Y-NM600 based on Phase 1A results
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Y-NM600
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Archeus Technologies, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator