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AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

This research study, called a Phase 1b/2 trial, is looking into a new treatment called MK-1045 for people with Non-Hodgkin Lymphoma. The main goals are to find out if the treatment is safe, what side effects it might cause, and if it helps to shrink the cancer. The study will test MK-1045 on its own or in combination with other anti-cancer drugs. It’s split into two main parts: an early stage to check for safety and dosage, and a later stage to see how effective it is. Doctors will closely monitor participants for any health changes and measure how well the treatment is working. This is for adults aged 18 and over.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
73
Start
28 May 2026

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to test new treatments in people. It's looking at a new drug called MK-1045 for a type of cancer called Non-Hodgkin Lymphoma. Lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

The study has two main aims. First, it wants to find out if MK-1045 is safe and what side effects it might cause, both when given on its own and when combined with other anti-cancer medicines. This is a very important part of testing new drugs. Second, it will check how well MK-1045 works at treating Non-Hodgkin Lymphoma – for example, if it can reduce the size of the cancer.

Because it's a 'Phase 1b/2' study, it means it's still in the earlier stages. Phase 1b focuses on safety and finding the right dose, while Phase 2 starts to look at how effective the treatment is. By doing this research, doctors aim to find better ways to treat Non-Hodgkin Lymphoma in the future.

Key takeaways

  • This study is testing a new drug (MK-1045) for Non-Hodgkin Lymphoma.
  • It aims to find out if the drug is safe and if it helps shrink the cancer.
  • The drug may be given alone or with other treatments.
  • It's a Phase 1b/2 study, meaning it's in the early stages of testing.
  • Participants will have regular visits, tests, and medical monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

Beyond age and sex, there will be other specific health requirements that your study doctor will check very carefully. These might include details about your specific type of Non-Hodgkin Lymphoma, your general health, and any other medications you are currently taking. It's important to meet all these criteria to ensure your safety and the accuracy of the study results.

Your doctor will discuss all the requirements with you to see if this study is a good option for your individual situation.

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 a diagnosis of Non-Hodgkin Lymphoma?
  3. Are you able to attend regular clinic visits?
  4. Are you willing to potentially receive a new, experimental drug?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the investigational drug, MK-1045, either by itself or with other anti-cancer treatments. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and see how the treatment is working. Doctors will especially be looking for any side effects and how your body reacts to the medication. The number of visits, tests, and overall duration of treatment will vary depending on which group you are in and how you respond to the treatment. There will also be follow-up appointments after your treatment period finishes.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment for Non-Hodgkin Lymphoma that isn't widely available yet, which could help your condition. However, there are potential risks, including side effects from the new drug or other treatments, which could be mild or more serious. The research team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Poland
  • Unverified
    Italy
  • Unverified
    France
  • Unverified
    Germany
  • Unverified
    Spain

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What does 'Phase 1b/2' mean?

This means the study is in its early stages. Phase 1b focuses on finding a safe dose and checking for side effects, while Phase 2 starts to look at how well the treatment works.

What is MK-1045?

MK-1045 is a new drug being tested in this study to see if it can help treat Non-Hodgkin Lymphoma.

Will I get MK-1045 or a different treatment?

You might receive MK-1045 on its own or in combination with other anti-cancer medicines, depending on which part of the study you are in.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, for any reason, without affecting your regular medical care.

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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