RecruitingPHASE2INTERVENTIONAL

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

This study is investigating a new medication, INCB123667, for women diagnosed with a type of ovarian cancer that has become resistant to standard platinum-based chemotherapy. This means the cancer has either returned or continued to grow, even after initial treatment with these common drugs. The main goals are to understand how safe INCB123667 is and how well it works. Researchers are particularly interested in its effect on cancers with high levels of a specific protein called Cyclin E1. This research is important because it could lead to new treatment options for patients whose ovarian cancer no longer responds to existing therapies, offering hope for improved care and outcomes in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Incyte Corporation

Enrolment target

160

Start

12 Nov 2025

Estimated completion

24 Oct 2027

Ovarian Cancer

What is this study about?

This study is focused on finding new ways to treat ovarian cancer, specifically for women whose cancer has become 'platinum-resistant'. This means that their cancer has either not responded well to, or has grown back after, standard chemotherapy treatments that include platinum-based drugs. It's a challenging situation, and this new drug, INCB123667, aims to offer another option.

The researchers want to see if INCB123667 is both safe to use and effective at controlling the cancer. They are particularly interested in how it works in cancers that have high levels of a protein called Cyclin E1. High levels of this protein might make the cancer behave in a certain way, and INCB123667 might be designed to target this.

Developing new treatments is vital for improving outcomes for patients with ovarian cancer, especially when the disease becomes harder to treat. Studies like this help us understand if new medications can provide relief, slow down the cancer, and ultimately improve quality of life for those affected.

Key takeaways

This study is testing a new drug, INCB123667, for platinum-resistant ovarian cancer.
It aims to see if the drug is safe and effective, especially for cancers with high Cyclin E1 protein levels.
Participation involves receiving the drug and regular health checks including blood tests and scans.
You must have certain types of ovarian cancer and have received 1 to 4 previous lines of treatment.
Potential risks and benefits will be discussed, and you can withdraw at any time.
The study seeks to find new treatment options for a challenging form of ovarian cancer.

Who may be eligible?

This study is for women with a specific type of ovarian cancer (high-grade serous, fallopian tube, or primary peritoneal cancer) that has become resistant to platinum-based chemotherapy. This generally means your cancer has come back or gotten worse despite treatment. You must have received between one and four previous lines of treatment for your cancer, and sometimes you need to have tried specific drugs like bevacizumab or mirvetuximab soravtansine unless there was a medical reason not to.

You would not be able to join if you have certain other types of ovarian cancer (like endometrioid or clear cell), or if your cancer initially didn't respond at all to the first platinum-based treatment. Other reasons for not being able to join include having serious heart problems, cancer that has spread to the brain, or another type of cancer that needs active treatment. You would also need to provide a recent tissue sample (biopsy) of your cancer for analysis.

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.

Do you have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer?
Has your cancer returned or grown despite platinum-based chemotherapy?
Have you had between 1 and 4 previous lines of cancer treatment?
Can you provide a recent biopsy sample of your cancer?
Do you have serious heart problems or cancer spread to your brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, INCB123667. The study team would closely monitor your health and the effects of the treatment through regular visits. These visits would likely include physical examinations, blood tests, and scans to track your cancer's response. You might also be asked to complete questionnaires about how you are feeling. Throughout your participation, there would be opportunities to discuss any questions or concerns you have with the medical team. The total duration of your involvement would depend on how your body responds to the treatment and the study plan, but you are free to withdraw at any time.

Potential risks and benefits

While we hope that INCB123667 might help control your cancer, there's no guarantee of direct benefit to you. We are still learning if and how well this drug works. Like all medications, INCB123667 may have side effects, which the medical team will explain in detail before you decide to join. Your safety and well-being are the top priority, and you would be closely monitored throughout the study. Remember, taking part in a clinical trial is always voluntary, and you can withdraw at any time, for any reason, without affecting your future medical care.

Locations (79)

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

Usa Health Mitchell Cancer Institute
Verified postcode
Mobile, United States· Recruiting
University of California, Los Angeles Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
Verified postcode
San Diego, United States· Recruiting
Medstar Georgetown University Hospital
Verified postcode
Washington D.C., United States· Recruiting
Florida Cancer Specialists & Research Institute
Verified postcode
Fort Myers, United States· Recruiting
Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States· Recruiting
Mount Sinai Comprehensive Cancer Center
Verified postcode
Miami Beach, United States· Recruiting
Florida Cancer Specialists & Research Institute
Verified postcode
West Palm Beach, United States· Recruiting
Northeast Georgia Medical Center Gainesville
Verified postcode
Gainesville, United States· Recruiting
Parkview Research Center
Verified postcode
Fort Wayne, United States· Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Verified postcode
Indianapolis, United States· Withdrawn
University of Iowa Hospital and Clinics
Verified postcode
Iowa City, United States· Recruiting

Common questions

What is 'platinum-resistant ovarian cancer'?

This means your ovarian cancer has either returned or continued to grow despite previous treatment with chemotherapy drugs that contain platinum.

What is INCB123667?

It's a new medication being tested in this study to see if it can help treat ovarian cancer that has become resistant to other standard treatments.

What is 'Cyclin E1 Overexpression'?

This refers to your cancer cells having higher than usual levels of a specific protein called Cyclin E1. The study is particularly looking at how INCB123667 affects cancers with this feature.

Will I have to pay to join this study?

No, you will not have to pay to participate in the study or for the study medication.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can choose to leave the study at any time without giving a reason and without it affecting your medical care.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

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