RecruitingPHASE1INTERVENTIONAL

Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer

This study is investigating a new medication called CC-1 for men with prostate cancer that has returned after their initial treatment. This return is known as 'biochemical recurrence' when blood tests show a rise in PSA. CC-1 is an antibody designed to target prostate cancer cells. The main goals of this early-stage study are to see if CC-1 is safe, how well people tolerate it, and to find the best dose. It also aims to see if there are any early signs that it might be effective. Participants will receive CC-1 through an infusion into their vein, and doctors will carefully monitor them throughout the treatment cycles.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University Hospital Tuebingen

Enrolment target

Start

11 Nov 2022

Estimated completion

01 Dec 2026

Prostate Cancer Recurrent

What is this study about?

This study is about a new treatment called CC-1 for men who have had a rise in their PSA levels after being treated for prostate cancer. When your PSA level goes up again, it's called 'biochemical recurrence.' This means the cancer might be coming back, even if scans don't yet show new tumours in other parts of the body. We're hoping to find a new way to help stop or slow down the cancer at this stage.

CC-1 is a special type of drug called an antibody. Think of antibodies as tiny, smart guides that can find and attach to specific targets. In this case, CC-1 is designed to find prostate cancer cells and also cells in the blood vessels that feed tumours. It has a clever design that aims to reduce side effects while still being effective. This early study will help us understand more about how it works in people.

Because this is a new drug, the study is split into two parts. In the first part, we'll slowly increase the dose of CC-1 to find the safest and most effective amount. In the second part, more people will receive that chosen dose. Participants will get CC-1 as an infusion into a vein, a couple of times a week over several weeks. Your doctors will explain the full schedule if you're interested in taking part.

Key takeaways

Tests a new drug (CC-1) for prostate cancer that has returned.
Aims to find the safest dose and see if it helps.
Treatment given through intravenous infusions.
Only for men with 'biochemical recurrence' (rising PSA) and no distant spread.
Close medical monitoring throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer in the past. To be considered, your prostate cancer must show signs of 'biochemical recurrence,' meaning your PSA levels have started to rise again after your previous treatment, but without any signs of the cancer spreading to distant parts of your body based on special scans.

There are also specific medical checks you need to pass. For example, your previous prostate cancer treatment and how quickly your PSA is rising will be taken into account. You'll need to be generally well with good organ function (blood, kidney, and liver). If you have a female partner who could get pregnant, you'll need to agree to use effective birth control during and after the study.

Before joining, you'll need to understand what the study involves and be able to commit to the treatment schedule and follow-up appointments. The research team will carefully review all your medical information to see if this study is right for you.

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?
Have you been diagnosed with prostate cancer in the past?
Has your PSA level started to rise again after previous treatment?
Are you generally well and able to attend regular hospital visits?
Are your kidney, liver, and blood test results within acceptable ranges?
Could you commit to using effective birth control if applicable?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, CC-1, through an infusion into a vein. This infusion will take about 3 hours each time. Initially, you'll receive lower doses of CC-1 as a safety step. After that, if you continue in the study, you'll typically have infusions twice a week for three weeks, followed by a break, and then the cycle repeats. These cycles will continue for a set period, which the study team will explain.

Throughout the study, you'll have regular hospital visits for blood tests, physical examinations, and other assessments to check your health, how you're responding to the treatment, and to monitor for any side effects. The study team will explain the full schedule of visits and tests beforehand. The total duration of your participation will depend on the study phase and your individual response, but there will be follow-up appointments even after you stop receiving treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment (CC-1) that isn't yet widely available, and close medical monitoring. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known. The study team will explain all known and possible side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What does 'biochemical recurrence' mean?

It means your PSA blood levels have started to rise again after your initial prostate cancer treatment, suggesting the cancer might be returning, even if it hasn't spread to other areas.

What is CC-1?

CC-1 is a new antibody drug being tested. It's designed to specifically target prostate cancer cells and the blood vessels that feed tumours.

How will I receive the treatment?

You will receive CC-1 through an 'infusion', which means it will be given directly into your bloodstream through a drip, usually in your arm.

Why is this study split into two parts?

The first part aims to find the safest and most effective dose of CC-1. Once this dose is found, the second part will evaluate it in more participants.

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

Yes, in this study (which is 'open-label'), everyone who takes part will receive the CC-1 drug. There isn't a placebo group.

How to find out more

Walz

kketi@med.uni-tuebingen.de +49(0)707129 Official trial record

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