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

KANDOVA - A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

This research study, called KANDOVA, is looking at a new treatment called KAND567. This new medicine is given together with an existing chemotherapy drug called carboplatin. The study is for women who have ovarian, fallopian tube, or primary peritoneal cancer that has returned after previous treatment. The main goal of the first part of the study is to check how safe KAND567 is when given with carboplatin and to find the most suitable dose. The study will carefully monitor for any side effects. Later, the study will look at how well this combination treatment works to shrink tumours or stop them from growing, and how it affects how long people live comfortably. This is an open-label study, meaning both patients and doctors will know which treatment is being given.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Kancera AB

Enrolment target

Start

01 Oct 2024

Recurrent epithelial ovarian fallopian tube or primary peritoneal cancer.

What is this study about?

This study is called KANDOVA, and it's looking into a new way to treat certain cancers in women. Specifically, it's for women who have ovarian, fallopian tube, or primary peritoneal cancer that has unfortunately come back after they've already had treatment. The main idea is to combine a new medicine, called KAND567, with a chemotherapy drug that's already used, called carboplatin. Think of it like giving two different helpers to fight the cancer at once.

The research is happening in two main steps. The first step is all about safety. The doctors want to find out how well people tolerate KAND567 when it's given with carboplatin, and to discover the best dose of KAND567 to use. They will be watching very closely for any side effects and how people are feeling. Once they've found a good dose, the second step will look more closely at how effective this combination treatment is. This means they'll be checking to see if it helps to shrink tumours, stop their growth, or improve the patient's quality of life.

This is an important step in trying to find better ways to treat these cancers. By carefully studying new combinations like this, researchers hope to offer more options and better outcomes for women facing these conditions.

Key takeaways

Targets recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Tests a new medicine (KAND567) combined with standard carboplatin chemotherapy.
Mainly focused on finding the safest dose and understanding side effects.
Also looking at how well the treatment shrinks tumours and affects survival.
Participation involves regular hospital visits, tests, and scans.
You can stop participating at any time.

Who may be eligible?

This study is specifically for women who are 18 years old or older. If you're considering taking part, you must have been diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after you've already had treatment for it.

There might be other health conditions or previous treatments that could mean this study isn't right for you. The study team will need to check your full medical history to make sure taking part is safe and appropriate for your situation.

It's very important to chat with your doctor if you're interested, as they can help you understand all the requirements and decide if this study is potentially a good fit 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 woman who is 18 years old or older?
Have you been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer?
Has your cancer come back after having previous treatment?
Are you able to travel to the study site for regular appointments?
Are you willing to undergo regular blood tests, scans, and other medical checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive doses of the new medicine KAND567 along with carboplatin chemotherapy. These will most likely be given as infusions (drips) into your vein. The schedule of how often you receive these treatments will be carefully planned by the study doctors.

Throughout the study, you'll have regular hospital visits. During these visits, the study team will carry out several checks. This will include blood tests, urine tests, checking your blood pressure and heart rate (vital signs), and sometimes an ECG (a simple test to check your heart's electrical activity). They will also ask you lots of questions about how you're feeling and any side effects you might be experiencing. They'll also measure your pain levels. To see how the treatment is working, you will have scans at specific times to check the size of your tumours. The study will track your health for a period after treatment finishes, and the total duration of your involvement could be several months or longer.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could help your cancer. However, it's also possible that the treatment may not work for you, or it could cause side effects. The study team will monitor you very closely for any side effects, which could range from mild to more serious. You will be told all known risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Denmark
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Unverified
Norway
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Unverified
Sweden

Common questions

What kind of cancer is this study for?

This study is for women with ovarian, fallopian tube, or primary peritoneal cancer that has returned after previous treatments.

What is KAND567?

KAND567 is a new medicine being tested. It's given alongside carboplatin, a type of chemotherapy already used for these cancers.

What is the main goal of the study?

The main goal is to check how safe KAND567 is when given with carboplatin, to find the best dose, and to see how well it works.

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

Yes, this is an 'open-label' study, meaning both you and your doctors will know you are receiving KAND567 plus carboplatin.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, for any reason, and your medical care will not be affected.