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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

An Open-label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

This research is testing a new medicine, XmAb24306, in people who have solid tumors that have spread or are advanced. It's a 'Phase 1' study, which means it's one of the first times this drug is being given to humans. Scientists want to see if it's safe to use, find the right dose, and understand how it works in the body. They will study XmAb24306 by itself and also in combination with an existing drug called atezolizumab. The main goal is to find a safe and effective starting point for future research into treating these types of cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Genentech Inc.
Enrolment target
99
Start
15 Apr 2024

What is this study about?

Imagine your body as a complex system, and sometimes, cells can grow in an uncontrolled way, forming what we call solid tumors. When these tumors are advanced or have spread (metastasized) to other parts of the body, they can be challenging to treat. Scientists are always working to find new ways to help patients with these conditions.

This particular study is focusing on a new investigational medicine called XmAb24306. It's a special type of study called a 'Phase 1' trial. This is a very early stage of research where doctors give a new medicine to people for the first time. The main aim isn't to cure the disease at this stage, but to carefully check how safe the medicine is, understand how the body handles it, and find the right dosage that can be safely used in future studies.

Researchers will be testing XmAb24306 in two ways: first, by itself, and then in combination with another approved cancer medicine called atezolizumab. By doing this, they hope to learn if XmAb24306 can be a helpful new treatment option and decide how best to use it for patients in the future.

Key takeaways

  • This study is testing a brand-new medicine, XmAb24306, for advanced solid tumors.
  • It's a Phase 1 study, focusing on safety and finding the best dose.
  • The new medicine is tested alone and with another drug, atezolizumab.
  • It's for adults aged 18 and over, with certain types of advanced cancer.
  • Regular monitoring and visits are part of taking part in the study.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.

The most important medical requirement is that you have been diagnosed with an advanced or metastatic solid tumor. This means a tumor that has grown significantly or has spread from where it started to other parts of your body. Doctors will look at your specific cancer diagnosis and overall health to see if this study is a good fit for you.

Because this is a Phase 1 study, there will be other specific medical checks to make sure joining the trial is safe for you. This might include reviews of your medical history, current health status, and other treatments you may have had.

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. Have you been diagnosed with a solid tumor that is advanced or has spread?
  3. Are you able to attend regular clinic appointments and follow study instructions?
  4. Are you willing to potentially receive a new, experimental medicine?
  5. Are you male or female?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, XmAb24306, either on its own or with atezolizumab. Because it's an early-stage study, you would have regular visits to the clinic. These visits are essential for the study doctors and nurses to closely monitor your health, check for any side effects, and see how your body is responding to the treatment.

These visits might involve physical examinations, blood tests, scans (like CT or MRI scans) to check your tumor, and questionnaires about how you are feeling. The frequency of visits might be more intensive at the beginning and then become less frequent over time. The total length of your participation would depend on how your body responds and if you continue to meet the study requirements, but you would be informed of the expected duration. There will also be a follow-up period after you stop receiving the study medication to monitor your long-term health.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing an investigational new medicine before it's widely available. However, since XmAb24306 is new, there could be unknown side effects or it might not help your condition. All medicines carry risks, and the study team will carefully monitor you for any side effects, which they will explain in full detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

Common questions

What does a 'solid tumor' mean?

A solid tumor is a type of cancer that forms a solid mass. It's different from blood cancers like leukaemia.

What is a 'Phase 1' clinical trial?

Phase 1 is the first stage where a new medicine is given to people. It's mainly about checking if it's safe and finding the right dose.

What is atezolizumab?

Atezolizumab is an approved cancer medicine that works by helping your body's immune system fight cancer.

Will I get the new medicine or a dummy treatment?

In this study, everyone will receive either XmAb24306 on its own or XmAb24306 with atezolizumab. There is no dummy treatment being used.

How long would I be in the study?

The study length varies depending on how you respond, but you would have regular check-ups and follow-up care until your participation ends.

How to find out more

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

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