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Active not recruitingPHASE2INTERVENTIONAL

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies

This research study is looking at a new way to understand how certain cancers respond to treatment. If you have advanced or metastatic melanoma, Merkel cell cancer, kidney cancer (renal cell carcinoma), or a type of non-small cell lung cancer, you might be interested. The study involves a special type of scan called a PET/CT. Before the scan, you'll be given a small amount of a substance called zirconium Zr 89 crefmirlimab berdoxam. The aim is to see if images from this scan can help doctors predict whether your cancer will respond well to a type of treatment called immuno-oncology therapy. This could help tailor treatments better in the future.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
ImaginAb, Inc.
Enrolment target
70
Start
09 Dec 2021
Estimated completion
01 Jul 2025

What is this study about?

This study is about helping doctors understand how different types of advanced or metastatic cancer might respond to a specific treatment called immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells. It's a really important treatment for many people.

Researchers are using a special imaging test called a PET/CT scan. For this study, before your scan, you'll receive a small amount of a substance known as zirconium Zr 89 crefmirlimab berdoxam. This substance is designed to help specific areas of your body show up on the PET/CT scan. The main goal is to see if the information from this special scan can give doctors clues about whether your cancer will react positively to immunotherapy. This kind of information could be vital for making future treatment decisions and helping patients receive the most effective care.

By taking part, you'd be helping scientists gather more information about how this new scanning method works. This could pave the way for better ways to predict treatment success for people with melanoma, Merkel cell cancer, kidney cancer, and non-small cell lung cancer, ultimately leading to more personalised and effective care.

Key takeaways

  • This study uses a special scan (PET/CT) to predict how well immunotherapy will work.
  • It's for people with advanced melanoma, Merkel cell, kidney, or non-small cell lung cancer.
  • The study substance is given before the scan to help visualise cancer features.
  • The goal is to improve future understandings of cancer treatment responses.
  • Participation could help advance personalised cancer care.
  • You must be eligible for immunotherapy and have measurable cancer.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with an advanced or metastatic cancer that cannot be cured by surgery. Specifically, we are looking for people with non-uveal/non-mucosal melanoma, Merkel cell carcinoma, a specific type of kidney cancer (clear cell renal cell carcinoma or renal cell carcinoma with sarcomatoid features), or non-small cell lung cancer.

To be eligible, you must be a candidate for first or second-line immunotherapy. This means your doctor thinks immunotherapy (either alone or sometimes with other specific treatments like VEGFR-directed or tyrosine kinase inhibitor drugs for kidney cancer) is an appropriate treatment for you, and it won't include chemotherapy. Even if you have certain genetic changes like KRAS G12C mutations in lung cancer, you might still be considered.

You also need to have at least one cancer site that can be measured on scans (like CT or MRI) and hasn't been treated with radiation recently. The study team will check all your medical details carefully to make sure you meet all the necessary requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced melanoma, Merkel cell cancer, kidney cancer, or non-small cell lung cancer that can't be removed by surgery?
  3. Is your doctor considering immunotherapy for you as a first or second treatment?
  4. Do you have at least one tumour that can be measured on a scan like a CT or MRI?
Answer every question to see your result.

What does participation involve?

The detailed involvement for this specific study isn't fully described in the provided information. However, generally, taking part in a study like this would typically involve an initial screening visit to ensure you meet all the health criteria. If eligible, you would likely have at least one PET/CT scan (and potentially other scans like CT or MRI) where you'd receive the study substance (zirconium Zr 89 crefmirlimab berdoxam) before the scan. There will also be follow-up visits and assessments to track your health and how your cancer is responding to your regular immunotherapy treatment. Total duration refers to how long researchers will follow your progress, which could range from several months to a few years, depending on the study design.

Potential risks and benefits

Participating in this study might offer the benefit of deeper insight into your cancer and potential response to treatment through advanced imaging. It's important to remember that this study is primarily for research, aiming to improve future cancer care rather than directly treating your cancer. As with any medical procedure, there are potential risks, mainly associated with the imaging substance and the scans themselves, such as allergic reactions or discomfort. You will be closely monitored for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • CARTI Cancer Center
    Verified postcode
    Little Rock, United States
  • City of Hope
    Verified postcode
    Duarte, United States
  • Providence Saint John's Cancer Institute
    Verified postcode
    Santa Monica, United States
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States
  • UT Southwestern Medical Center
    Verified postcode
    Dallas, United States
  • University of Washington
    Verified postcode
    Seattle, United States
  • Macquarie University Hospital
    Verified postcode
    Macquarie Park, Australia
  • Princess Alexandra Hospital
    Verified postcode
    Woolloongabba, Australia
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia
  • Olivia Newton-John Cancer Research Insititute
    Verified postcode
    Heidelberg, Australia
  • Peter MacCallum Cancer Centre
    Verified postcode
    Melbourne, Australia
  • University Hospitals Leuven
    Verified postcode
    Leuven, Belgium

Common questions

What is 'advanced or metastatic' cancer?

This means the cancer has spread from where it started to other parts of your body. 'Advanced' usually means it's progressed beyond its original site.

What is 'immuno-oncology therapy'?

This is a type of cancer treatment that uses your body's own immune system to fight the cancer cells. It helps your immune system recognise and attack cancer.

What is a 'PET/CT scan'?

It's a combination of two scans that provide detailed pictures of your body. A PET scan shows how your cells are working, and a CT scan shows detailed pictures of your bones and soft tissues.

Will this study cure my cancer?

This study is for research purposes, aiming to understand if a special scan can predict how well immunotherapy works. It's not a direct treatment for your cancer, but the knowledge gained could help improve future treatments for others.

What is zirconium Zr 89 crefmirlimab berdoxam?

It's a special substance given before the PET/CT scan. It helps certain things show up more clearly on the scan, allowing researchers to study specific aspects of your cancer.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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