A Study of INCB123667 in Patients With Platinum-Resistant Ovarian Cancer That Has High Levels of Cyclin E1 Protein

2 1 1

What is this study about?

This study is looking at a treatment for ovarian cancer that has become resistant to platinum-based chemotherapy. The study focuses on a specific type of ovarian cancer called high-grade serous epithelial ovarian cancer, which can also occur in the fallopian tubes or the lining of the abdomen. The cancer being studied has a particular characteristic where a protein called cyclin E1 is present at higher than normal levels. The treatment being tested is INCB123667, which is given as a tablet taken by mouth.

The purpose of the study is to see how well INCB123667 works in treating this type of cancer when the disease no longer responds well to platinum-based treatments. Platinum-resistant disease means that the cancer has either grown or come back within six months after the last platinum treatment, or has continued to grow during platinum treatment. The study will look at whether the treatment can shrink the tumors or stop them from growing. Participants in this study will have already received between one and four previous treatment plans for their cancer, and will have a tumor sample tested to confirm that cyclin E1 is overexpressed and to check the level of another protein called FRα.

During the study, participants will take INCB123667 tablets for up to 24 months. Before starting treatment, a tissue sample from the tumor will be collected. The study doctors will regularly check how the cancer is responding to treatment using imaging scans and will monitor for any side effects through physical examinations, blood tests, and heart monitoring. The study will track how long any tumor shrinkage lasts, how long participants live without their disease getting worse, and overall survival. Safety will be closely monitored throughout the study by checking for unwanted effects and whether any dose changes are needed.

1 Initial assessment and biopsy

A tissue sample will be collected from the tumor through a biopsy procedure. This is required before starting treatment.

Blood samples will be taken to check pregnancy status and general health parameters.

Imaging scans such as CT (computed tomography) or MRI (magnetic resonance imaging) will be performed to measure the tumor size and location.

A physical examination will be conducted, including measurement of vital signs such as blood pressure, heart rate, and temperature.

An ECG (electrocardiogram) will be performed to assess heart function.

The tumor tissue will be tested to determine the level of cyclin E1 expression, which is a protein that can affect cell growth.

The tumor tissue will also be tested for FRα (folate receptor alpha) expression using laboratory methods.

2 Starting treatment with INCB123667

Before receiving the first dose, a urine test will be performed to confirm the absence of pregnancy.

Treatment will begin with INCB123667, which is an investigational medication provided as a tablet taken by mouth.

The specific dosage, frequency, and duration of taking the medication will be determined by the study doctor.

The medication should be taken orally as instructed.

3 Regular monitoring during treatment

Physical examinations will be performed regularly to monitor overall health status.

Vital signs will be measured at scheduled intervals.

Blood samples will be collected periodically for laboratory testing to monitor organ function and detect any potential side effects.

ECG tests will be repeated at specific timepoints to continue monitoring heart function.

Imaging scans (CT or MRI) will be performed at scheduled intervals to assess how the tumor is responding to treatment according to RECIST v1.1 criteria, which are standardized rules for measuring tumor changes.

Any side effects or health changes experienced will be recorded and assessed throughout the treatment period.

4 Assessment of treatment response

The tumor response will be evaluated by an independent review committee and by the study doctor using imaging scans.

The assessment will determine if the tumor has shrunk (partial response), disappeared completely (complete response), stayed the same size (stable disease), or grown (progressive disease).

If the tumor responds to treatment, additional scans will be performed to confirm the response.

The time period during which the tumor remains controlled will be measured.

5 Continuation or modification of treatment

Treatment with INCB123667 will continue as long as the tumor does not grow and side effects remain manageable.

If certain side effects occur, the dose of medication may be reduced, or treatment may be temporarily paused.

If the tumor grows or unacceptable side effects develop, treatment with the study medication will be stopped.

Regular monitoring visits will continue throughout the treatment period.

6 End of treatment and follow-up

Once treatment with INCB123667 is stopped, follow-up assessments will continue.

Health status will be monitored, including survival and any ongoing side effects.

Pregnancy prevention measures must be maintained for 180 days (approximately 6 months) after the last dose of study medication.

Oocyte (egg cell) donation must be avoided during this same period.

Follow-up may continue until the end of the study, which is estimated to occur in October 2028.

Who Can Join the Study?

You must be a female participant who is 18 years old or older
You must be able to understand and willing to sign a written consent form, which is a document that explains the study and your rights as a participant
You must be willing and able to follow all study requirements
You must have a confirmed diagnosis through tissue examination of high-grade serous epithelial ovarian cancer, which is an aggressive type of cancer that can occur in the ovaries, fallopian tube, which are the tubes connecting the ovaries to the uterus, or primary peritoneal cancer, which is cancer in the lining of the abdomen
You must have platinum-resistant disease, which means your cancer has not responded well to platinum-based chemotherapy drugs or has come back within a certain time after treatment
If you have only had 1 treatment with platinum-based chemotherapy, you must have received at least 4 treatment cycles, had your cancer shrink or stay stable, and then the cancer must have grown back between more than 3 months and up to 6 months after your last platinum dose
If you have had 2 to 4 treatments with platinum-based chemotherapy, your cancer must have grown during treatment or within 6 months after your last platinum dose
You must be willing to have a biopsy before treatment, which is a procedure where a small sample of tissue is removed from your body for testing
The level of a protein called cyclin E1 in your tumor must be known through a special laboratory test called IHC, which stands for immunohistochemistry and is a way to detect specific proteins in tissue samples
The level of a protein called FRα, which stands for folate receptor alpha, in your tumor must be known through laboratory testing
You must have received at least 1 but no more than 4 previous treatment plans since your initial diagnosis, and single-drug therapy must be considered a suitable next treatment option for you
You must have received a drug called bevacizumab unless there was a medical reason you could not take it
If your tumor tests positive for FRα protein, you must have received a drug called mirvetuximab soravtansine unless there was a medical reason you could not take it
Your cancer must have grown or worsened during or after your last cancer treatment before joining this study
You must have measurable disease, which means your cancer can be seen and measured on CT or MRI scans, which are imaging tests that create detailed pictures of the inside of your body, according to specific measurement guidelines called RECIST v1.1
You must be able to swallow medication by mouth
You must have an ECOG performance status of 0 to 1, which is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can do light work
You must be willing to avoid becoming pregnant and must have a negative pregnancy test before starting the study drug
If you are able to become pregnant, you must agree to use highly effective birth control methods with at least 99% effectiveness and not donate eggs from the time you join the study through 180 days after your last dose of study drug

Who Cannot Join the Study?

The study is only for female patients, so male patients cannot participate
Patients who are outside the specified age range for this study cannot participate
Patients who do not have ovarian cancer cannot participate
Patients whose ovarian cancer does not show cyclin E1 overexpression (which means their cancer cells do not produce too much of a specific protein called cyclin E1) cannot participate in Cohort 1
Patients who do not have PROC (platinum-resistant ovarian cancer, which means cancer that does not respond well to platinum-based chemotherapy drugs) cannot participate in Cohort 1

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Clinic De Barcelona	Barcelona	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Cbllaoiaz Usidqclipipgpy Sxbcjpgpq	Woluwe-Saint-Lambert	Belgium
Ibyaesko Czekuo Dyvciflpwacyegpuw	L'hospitalet De Llobregat	Spain
Fmxeikpty Peia Lo Itpxgoaanjhhc Bwtauttxm Dib Hvdyxxmc Ujvmwetuoltlc Lc Pxe	Madrid	Spain
Hibmczpy Vcro dtnnxqyt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	11.02.2026
Spain	Recruiting	11.02.2026

Trial locations

INCB123667 is an investigational medication being studied as a single treatment for patients with platinum-resistant ovarian cancer who have a specific protein called cyclin E1 that is overexpressed in their cancer cells. This medication is given alone without being combined with other cancer treatments in this study.

Investigated diseases:

Ovarian cancer

Ovarian Cancer – Ovarian cancer is a disease that occurs when abnormal cells in the ovaries begin to grow and multiply uncontrollably. The ovaries are two small organs located on either side of the uterus that produce eggs and female hormones. This type of cancer often develops slowly over time, but it may not cause noticeable symptoms in its early stages. As the disease progresses, the abnormal cells can form tumors that may spread to nearby tissues and organs in the pelvis and abdomen. Women with ovarian cancer may experience symptoms such as abdominal bloating, pelvic pain, difficulty eating, and frequent urination as the condition advances. The disease can affect women of any age, though it is more common in older women.

Trial ID:

2025-521513-14-00

Protocol code:

INCB123667-203

NCT ID:

NCT07023627

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A Study of INCB123667 in Patients With Platinum-Resistant Ovarian Cancer That Has High Levels of Cyclin E1 Protein

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?