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A Study of AZD4512 Alone or With Other Cancer Drugs for People With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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What is this study about?

This study is looking at a type of cancer called Non-Hodgkin lymphoma, which is a disease that affects certain white blood cells in the body’s immune system, specifically B-cells. The study focuses on patients whose cancer has come back after treatment or has not responded to previous treatments. The treatment being tested is AZD4512, which is an antibody drug conjugate, meaning it is a medicine that combines an antibody with a cancer-fighting drug to target cancer cells more directly. The study will look at AZD4512 when used alone or together with other cancer medicines.

The purpose of this study is to learn how safe AZD4512 is and how well the body can tolerate it, and to find the right dose that can be used for treatment. The study will also look at how the medicine moves through the body, how it affects the disease, and whether the body’s immune system reacts to it. During the study, participants will receive the medicine through an infusion into a vein. Doctors will monitor participants closely by checking vital signs, doing blood tests, and using imaging scans such as PET scans and CT or MRI scans to see how the disease responds to treatment. These scans are special types of medical imaging that help doctors see inside the body and measure the size of lymphoma areas.

The study will track various aspects including any side effects that occur, how long any positive responses to treatment last, and how long participants live. Doctors will also measure the levels of the medicine in the blood and check if the body develops any immune responses to it. The response to treatment will be assessed using a specific classification system for lymphoma that looks at whether the cancer shrinks, stays the same, or grows during treatment. This is a phase one and phase two study, which means it is an early stage of testing to gather important information about the new treatment.

1 Initial treatment period

You will receive AZD4512 as a single treatment or in combination with other cancer medications.

The medication will be administered through intravenous infusion, which means it will be delivered directly into your vein over a period of time.

The treatment will be given in cycles. The exact dose, frequency, and duration will be determined by the study doctor based on your response to the medication.

2 Safety monitoring period

During the initial treatment phase, you will be closely monitored for any side effects or adverse reactions to determine the appropriate dose of the medication.

Your vital signs, such as blood pressure, heart rate, and temperature, will be measured regularly.

Blood samples will be taken to check your organ function and blood cell counts to ensure your body is tolerating the treatment.

Any side effects you experience will be recorded and assessed for their severity and duration.

3 Disease assessment

You will undergo imaging scans to measure the size of your lymphoma. This may include PET scans (a type of imaging that shows metabolic activity in your body), CT scans (detailed X-ray images), or MRI scans (magnetic imaging).

These scans will help determine how your lymphoma is responding to the treatment.

The response will be evaluated according to established classification systems for lymphoma.

4 Blood sample collection for medication levels

Blood samples will be collected at specific times to measure the levels of AZD4512 and its components in your bloodstream.

These measurements help understand how your body processes the medication, including how quickly it is absorbed, distributed, and eliminated.

The timing of these blood draws will be scheduled around your treatment infusions.

5 Immune response testing

Blood samples will be taken to check if your body develops an immune response to the medication.

This involves testing for anti-drug antibodies, which are proteins your immune system might produce in response to the treatment.

This information helps assess how your immune system is reacting to the medication over time.

6 Continued treatment cycles

If you tolerate the treatment well and your lymphoma responds positively, you will continue receiving AZD4512 in repeated cycles.

The treatment will continue as long as it is beneficial for you and you do not experience unacceptable side effects.

Regular monitoring of your health status, blood tests, and imaging scans will continue throughout your participation.

7 Long-term follow-up

After completing the treatment phase, you will be followed for an extended period to monitor your overall survival and long-term health outcomes.

This follow-up will continue to track the duration of your response to treatment and whether the lymphoma returns.

The total duration of your participation in the study may extend until 2028, depending on when you join and how you respond to treatment.

Who Can Join the Study?

  • You must be 18 years of age or older
  • You must be able to understand and follow the study requirements and sign an informed consent, which is a document explaining the study that you agree to by signing
  • You must have measurable disease, meaning tumors that can be seen and measured on scans. For lymphomas that show up on FDG-PET scans (a special type of imaging test that uses a radioactive sugar to detect cancer), you need at least one tumor in a lymph node larger than 1.5 centimeters in its longest dimension, or at least one tumor outside lymph nodes larger than 1 centimeter. For lymphomas that do not show up well on FDG-PET scans, the same size requirements apply when measured on CT or MRI scans (other types of imaging tests)
  • Your ECOG Performance Status must be 2 or lower. This is a score from 0 to 5 that measures how well you can perform daily activities, where 0 means you are fully active and 2 means you can care for yourself but cannot work
  • Your life expectancy must be at least 12 weeks, meaning doctors expect you to live for at least 3 months
  • You must have adequate organ and bone marrow function, meaning your organs such as liver, kidneys, and bone marrow must be working well enough to handle the study treatment
  • You or your partner must use appropriate contraception (birth control methods) as required by local regulations during the study to prevent pregnancy
  • You must be able to attend all required study visits, follow the treatment plan, and complete all study procedures

Who Cannot Join the Study?

  • You have primary central nervous system lymphoma, which means lymphoma that started in your brain or spinal cord
  • You have a history of another type of cancer within the last 2 years, except for certain skin cancers or cancers that have been completely removed
  • You have active infection requiring treatment with antibiotics or antiviral medicines
  • You have known infection with HIV, which is a virus that affects the immune system
  • You have active infection with hepatitis B or C, which are viruses that affect the liver
  • You have had a stem cell transplant within the last 100 days, which is a treatment where blood-forming cells are replaced
  • You have graft versus host disease requiring treatment, which is a condition where transplanted cells attack your body
  • You have significant heart problems, including recent heart attack, unstable chest pain, or severe heart rhythm problems
  • You have uncontrolled high blood pressure despite taking medicines to lower it
  • You have severe lung disease requiring oxygen therapy
  • You have severe liver problems that affect how your liver works
  • You have severe kidney problems requiring dialysis, which is a treatment to clean your blood when kidneys don’t work properly
  • You have a history of bleeding problems or stroke
  • You are pregnant or breastfeeding
  • You have received certain cancer treatments within a specific time period before joining the study
  • You have received a live vaccine within 30 days before starting the study treatment
  • You have a known allergy to the study medicine or its ingredients
  • You are taking certain medicines that cannot be stopped or changed during the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Avuhych Ucojd Salilqbfo Ldgjtr Do Bfppsuc Bologna Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
31.10.2025

Trial locations

Investigated drugs:

AZD4512 is an experimental medication being tested in this study. It is being evaluated as a treatment for people with a type of cancer called B-cell non-Hodgkin lymphoma that has come back after previous treatment or has not responded to treatment. This medication may be given alone or together with other cancer medicines to see how safe it is and how well it works against this type of cancer.

Investigated diseases:

Non-Hodgkin Lymphoma – Non-Hodgkin lymphoma is a type of cancer that develops in the lymphatic system, which is part of the body’s immune system. It occurs when white blood cells called lymphocytes grow abnormally and uncontrollably, forming tumors in lymph nodes or other parts of the body. The disease can start in different types of lymphocytes, most commonly B-cells or T-cells. As the condition progresses, abnormal lymphocytes can accumulate in lymph nodes, causing them to swell, and may spread to other organs such as the spleen, liver, or bone marrow. The disease can develop slowly over many years or grow rapidly, depending on the specific type. Non-Hodgkin lymphoma encompasses many different subtypes, each with distinct characteristics and patterns of growth.

Trial ID:
2025-522371-29-00
Protocol code:
D9890C00001
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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