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Study on CD8 PET Imaging for Patients with Metastatic Solid Tumors Using 89Zr-Df-crefmirlimab, Nivolumab, and Cetrelimab

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What is this study about?

This clinical trial is focused on studying metastatic solid tumors, which are cancers that have spread from their original site to other parts of the body. The study involves a new imaging technique using a substance called 89Zr-Df-crefmirlimab. This substance is used in a type of scan called positron emission tomography (PET) to help visualize certain immune cells in the body. The trial aims to understand how this imaging agent spreads throughout the body and how it interacts with tumors before and during treatment with a type of cancer therapy known as anti-PD-1 antibody therapy. This therapy is designed to help the immune system recognize and attack cancer cells more effectively.

Participants in the study will receive the imaging agent 89Zr-Df-crefmirlimab through an intravenous injection, which means it is delivered directly into the bloodstream. The study will involve several PET scans to monitor the distribution of the imaging agent in the body and its uptake by tumors. These scans will be conducted at different times to see how the imaging agent behaves before and during the cancer treatment. The study will also collect information on how the tumors change in size and appearance during the treatment using imaging techniques like MRI.

The purpose of this study is to gather information that could improve the understanding of how the immune system interacts with cancer during treatment. This could potentially lead to better ways to monitor and treat metastatic solid tumors in the future. The study will run over several years, with participants being monitored throughout their treatment to assess the effectiveness and safety of the imaging agent and the cancer therapy. The trial will also look at any side effects or reactions to the treatments used in the study.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, which confirms your understanding and agreement to participate in the study.

2 screening and eligibility assessment

You will undergo a series of tests to confirm your eligibility for the trial. These tests will include blood tests, imaging scans, and a review of your medical history to ensure you meet the study criteria.

3 baseline assessments

Before starting the treatment, baseline assessments will be conducted. These include imaging scans such as PET and MRI to evaluate your current health status and tumor characteristics.

4 administration of 89zr-df-crefmirlimab

You will receive an injection of 89Zr-Df-crefmirlimab, a tracer used for imaging. This will be administered as a solution for injection through an intravenous line.

5 imaging and evaluation

After the tracer injection, imaging scans will be performed to assess the distribution of the tracer in your body. These scans help in evaluating the presence and activity of immune cells in your tumors.

6 treatment with anti-pd-1 antibody

You will begin treatment with an anti-PD-1 antibody, such as nivolumab. This medication is administered as a solution for infusion through an intravenous line. The dosage and frequency will be determined by the study team based on your specific needs.

7 ongoing assessments and monitoring

Throughout the trial, regular assessments will be conducted to monitor your response to the treatment. This includes repeated imaging scans, blood tests, and evaluations of your overall health and any side effects.

8 end of study visit

At the end of the study, a final visit will be scheduled to conduct comprehensive assessments. This will include imaging scans and a review of your health status to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • Age must be 18 years or older at the time of signing the consent form.
  • Must be willing and able to follow all the procedures required by the study.
  • If you are a woman who can have children or a man with a partner who can have children, you must agree to use a highly effective form of birth control (one that is very reliable when used correctly).
  • Must have a confirmed diagnosis of locally advanced or metastatic solid cancer types, and the study doctor believes you may benefit from anti-PD1 antibody therapy.
  • Your disease must have worsened after the first treatment or any later treatment, or there is no better first treatment available.
  • You must have at least one lesion (abnormal tissue) that can be accessed and is suitable for a biopsy, according to standard medical procedures.
  • You must have measurable disease as defined by standard criteria (RECIST v1.1). Lesions that were previously treated with radiation should not be counted unless they have worsened after treatment given at least 3 months earlier.
  • Your performance status (a measure of your ability to perform daily activities) must be 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • You must have a life expectancy of at least 12 weeks.
  • Your organs and bone marrow must be functioning adequately, as defined by specific medical tests, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Absolute neutrophil count of at least 1.0 x 109/L.
    • Absolute lymphocyte count of at least 0.75 x 109/L.
    • Platelet count of at least 75 x 109/L.
    • Serum creatinine level of no more than 1.5 times the upper limit of normal, or an estimated glomerular filtration rate greater than 30 mL/min/1.73 m2. A 24-hour urine test may be used instead to meet this requirement.
    • Adequate liver function, including:
      • Total bilirubin level of no more than 1.5 times the upper limit of normal (or 3 times if there is liver tumor involvement). If you have Gilbert’s syndrome, this requirement does not apply if your bilirubin level is unchanged from your baseline.
      • Aspartate aminotransferase (AST) level of no more than 2.5 times the upper limit of normal (or 5 times if there is liver tumor involvement).
      • Alanine aminotransferase (ALT) level of no more than 2.5 times the upper limit of normal (or 5 times if there is liver tumor involvement).
      • Alkaline phosphatase (ALP) level of no more than 2.5 times the upper limit of normal (or 5 times if there is liver or bone tumor involvement).
  • You must sign an informed consent form, which means you agree to participate in the study after being informed about all aspects of it.

Who Cannot Join the Study?

  • Patients who do not have metastatic solid tumors. This means the cancer has spread from its original site to other parts of the body.
  • Patients who are not suitable for ICI therapy. ICI stands for immune checkpoint inhibitors, which are drugs that help the immune system fight cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Uabboulgojye Mitxmkk Clkmsvx Gxqlulhya Groningen The Netherlands
Agcgrctdd Ugq Amsterdam The Netherlands
Hqwcuipt Vjmb drubswdo Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.11.2024
The Netherlands The Netherlands
Recruiting
01.11.2024

Trial locations

Investigated drugs:

89Zr-DF-crefmirlimab is a special imaging agent used in this clinical trial. It helps doctors see how a type of immune cell, called CD8, is distributed in the body. This is important because CD8 cells play a role in fighting cancer. The imaging agent is used before and during treatment to help doctors understand how the immune system is responding to the cancer treatment.

Anti-PD-1 antibody is a type of medication used to treat cancer. It works by helping the immune system recognize and attack cancer cells. In this trial, the anti-PD-1 antibody is used to see how it affects the cancer and the immune system, especially in combination with the imaging agent. This helps doctors learn more about how effective the treatment is and how it changes the cancer and the immune response over time.

Investigated diseases:

Metastatic Solid Tumors – Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. This process, known as metastasis, occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system. These tumors can affect various organs, including the liver, lungs, brain, and bones. The progression of metastatic solid tumors involves the growth and spread of cancer cells, leading to the formation of new tumors in distant organs. As the disease advances, it can cause symptoms related to the affected organs, such as pain, organ dysfunction, or other systemic effects. The behavior and progression of metastatic solid tumors can vary depending on the type of primary cancer and the organs involved.

Trial ID:
2024-515885-15-00
Protocol code:
10353
NCT ID:
NCT06534190
Trial Phase:
Human Pharmacology (Phase I) – Other

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