Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

LAVA1207-001/LAVA1207-002 A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cell engager, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer

This research is looking into a new treatment called LAVA-1207 for men who have prostate cancer that has spread and can no longer be controlled by standard hormone treatments. It's a 'Phase 1 and 2' study, meaning it's still in the early stages, focusing on safety first, then how well it works. The study will test LAVA-1207 on its own and in combination with other medicines, such as a low dose of interleukin-2 or Pembrolizumab (Keytruda). Doctors will carefully check for any side effects and see if the treatment helps to shrink the cancer. The aim is to find out more about this new potential treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

LAVA Therapeutics N.V.

Enrolment target

110

Start

27 Aug 2024

Prostate Cancer Prostate Cancer

What is this study about?

This study is a clinical trial, which means it's a careful medical research study involving people. It's focused on men who have prostate cancer that has spread to other parts of the body (called metastatic) and is no longer responding to standard hormone therapy treatments. This type of cancer is known as 'castration-resistant' because it continues to grow even when testosterone levels are very low.

The main goal of this particular trial is to learn more about a new investigative drug called LAVA-1207. Researchers want to understand if it's safe to use, how the body handles it, and if it can help fight the cancer. They will also look at whether combining LAVA-1207 with other existing cancer treatments, like a low dose of a medicine called interleukin-2 or Pembrolizumab (which you might know as Keytruda), could make it more effective. These combinations are designed to see if the new drug works better when given with other treatments.

Because this is an 'open-label' study, both the patients and the doctors will know which treatment is being given. The study is divided into two parts (Phase 1 and Phase 2a). Phase 1 is primarily about safety and finding the right dose, while Phase 2a will look more at how well the treatment shrinks the cancer and continues to monitor safety. The hope is that this research will lead to new and better ways to treat advanced prostate cancer.

Key takeaways

This study is for men with advanced prostate cancer that has resisted previous treatments.
It's testing a new drug, LAVA-1207, alone or combined with other cancer medicines.
The main goals are to check for safety and see if the new drug can shrink the cancer.
Participation involves regular clinic visits for treatments and health checks.
There are potential benefits (access to new treatment) and risks (side effects).
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older. The key factor is that you have prostate cancer that has spread and is no longer responding to hormone treatment, meaning it's 'castration-resistant'. Also, your cancer must have progressed despite other treatments you've already tried.

Participation is only open to men whose cancer has not responded to previous treatments, making it 'therapy refractory'. This means your doctors have tried other standard approaches, but the cancer is still growing or getting worse.

There will also be other specific medical requirements that your study doctor will discuss with you. These usually relate to your general health, other medical conditions you might have, and certain blood test results to make sure it's safe for you to take part.

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.

Are you a man, aged 18 or older?
Do you have prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone treatments?
Has your cancer continued to grow or get worse despite other treatments you've had?
(Your doctor will also check if you meet other specific health requirements.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study drug, LAVA-1207, which might be given alone or with other medicines like low-dose interleukin-2 or Pembrolizumab. This will be given through a drip (infusion) into your vein. You'll need to attend regular appointments at the study clinic.

These visits will involve various assessments, including blood tests, urine tests, physical check-ups, and scans (like CT or MRI scans) to see how your body is reacting to the treatment and if the cancer is responding. These checks are done to monitor your safety and the treatment's effect. The exact number of visits and the full duration of the study will be explained in detail by the study team, but clinical trials usually involve frequent visits early on, becoming less frequent over time. There will also be follow-up calls or visits after your treatment period.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as getting access to a new treatment before it's widely available. It also allows you to contribute to medical science, which could help future patients. However, there are potential risks, including side effects from the investigational drugs, which may be mild or more serious. No one knows for certain how you will react to a new medicine. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Netherlands

Common questions

What is LAVA-1207?

LAVA-1207 is a new drug being tested in this study to see if it can help treat advanced prostate cancer.

What does 'Phase 1 and 2a' mean?

These are early stages of drug testing. Phase 1 mainly checks for safety and the right dose, while Phase 2a looks at how well the drug works and continues to monitor safety.

What is 'therapy refractory metastatic castration resistant prostate cancer'?

This means your prostate cancer has spread, is no longer responding to hormone treatments, and has continued to grow despite other treatments you've had.

Will I know if I'm getting the new drug?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your ongoing medical care.