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Phase 3 Study of INCB123667 versus investigator's choice of chemotherapy drug combination in patients with platinum‑resistant ovarian cancer and cyclin E1 overexpression

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves women with ovarian cancer that no longer responds to platinum‑based treatment and shows cyclin E1 overexpression. The purpose of the study is to compare the effect of a new oral medication with standard chemotherapy.

The new medication, identified by the code name INCB123667, is given as a tablet taken by mouth each day. Participants may receive one of several standard chemotherapy options chosen by their doctor, including paclitaxel, topotecan, gemcitabine, or doxorubicin, all of which are administered through an intravenous (IV) infusion, meaning the drug is delivered directly into a vein.

After enrollment, participants are assigned to receive either the study pill or one of the IV chemotherapy drugs and are followed with regular clinic visits, imaging scans to check tumor size, blood tests, and quality‑of‑life questionnaires for several months. The trial will record how long patients live without the disease getting worse, known as progression‑free survival, and how long they live overall, referred to as overall survival, to evaluate the relative benefit of the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After enrollment you are assigned by a computer system to one of two groups: the test arm receiving incb123667 or the comparator arm receiving the investigator’s choice of chemotherapy.

  2. Step 2

    Start of study medication

    If you are in the test arm you begin taking an oral tablet containing 100 mg incb123667 once each day. the tablet is swallowed with water and taken continuously until disease progression or unacceptable side effects occur.

    If you are in the comparator arm you will receive an intravenous infusion of one chemotherapy agent chosen by the investigator. the possible agents and their standard doses are:

    paclitaxel: 80 mg/m2 given by intravenous infusion,

    topotecan hydrochloride: 4 mg/m2 given by intravenous infusion,

    gemcitabine hydrochloride: 1000 mg/m2 given by intravenous infusion,

    doxorubicin (caelyx): 40 mg/m2 given by intravenous infusion.

    The infusion is administered on the schedule defined by the investigator, typically repeated every few weeks.

  3. Step 3

    Clinic visits for safety monitoring

    You attend regular clinic visits that may coincide with each treatment cycle. during each visit a physical examination, vital‑sign measurements, and an electrocardiogram (ecg) are performed. blood samples are taken for laboratory tests. you also complete quality‑of‑life questionnaires (eortc qlq‑c30, eortc qlq‑ov28, eq‑5d‑5l).

  4. Step 4

    Radiologic assessments

    Imaging studies (such as ct or mri scans) are performed at baseline and then approximately every eight weeks to evaluate the tumor. the results are reviewed by an independent central reviewer to determine if the disease has progressed.

  5. Step 5

    Dose adjustments and treatment interruptions

    If side effects are observed, the study team may reduce the dose, pause treatment temporarily, or stop the study medication altogether, following predefined safety guidelines.

  6. Step 6

    End of treatment and follow‑up

    Treatment ends when disease progression is confirmed or when unacceptable toxicity occurs. after stopping the study medication you continue to be monitored for overall survival and any late side effects, with periodic visits and assessments as instructed by the investigator.

Who can join the trial?

15 criteria

  • You must be able to understand the study information and be willing to sign a written Informed Consent Form (ICF).
  • You must be a woman who is at least 18 years old (in France, between 18 and 99 years old) at the time you sign the ICF.
  • You need to be prepared to follow all study rules, attend scheduled visits, and complete required procedures.
  • You must have a confirmed diagnosis (by looking at the tumor cells under a microscope) of high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • Your cancer must be platinum‑resistant, meaning it got worse within 3 to 6 months after the last platinum‑based chemotherapy treatment.
  • You should have already been treated with the drug bevacizumab unless you could not safely receive it.
  • If your tumor tests positive for the protein FRα, you must have previously received the drug mirvetuximab soravtansine unless you have certain eye problems (such as active corneal disease, glaucoma, or diabetic eye disease) that prevent its use.
  • Your disease must have gotten worse while or after your most recent anticancer therapy before joining the study.
  • You must have tumor lesions that can be measured on a CT scan or MRI using standard criteria called RECIST v1.1. (These are rules doctors use to decide if a tumor can be measured reliably.)
  • You need to be able to swallow medication by mouth.
  • Your overall health level must be good, measured as an ECOG performance status of 0 or 1 (which means you are fully active or able to carry out light work).
  • You must agree to avoid becoming pregnant: you will need a negative pregnancy test before starting treatment, use reliable birth control, and follow specific timing rules for pregnancy testing and contraception.
  • You must be willing to provide a sample of your tumor tissue that was stored previously (an archival tumor tissue block) or, if none is available, agree to have a new biopsy taken before treatment.
  • The level of FRα expression in your tumor must already be known.
  • You must have received between 1 and 4 prior lines of systemic therapy (treatment that works throughout the whole body) after your initial cancer diagnosis. (Treatments given before surgery and after surgery count as one line; maintenance drugs, hormonal drugs, and changes made only because of side effects do not count as separate lines.)

Who cannot join the trial?

36 criteria

  • Having ovarian tumor types called endometrioid, clear cell, mucinous, sarcomatous, a mix that contains any of these, or having low‑grade or borderline (less aggressive) ovarian cancer.
  • Having cancer that got worse within 3 months after the last dose of first‑line platinum‑based chemotherapy (called primary platinum‑refractory disease).
  • Having a serious heart problem in the past 6 months, such as unstable chest pain, recent heart attack, severe heart failure, or dangerous heart rhythm problems (New York Heart Association Class III/IV). A stable pacemaker with well‑controlled rhythm for at least 1 month is allowed.
  • Having an abnormal heart test (ECG) that the doctor thinks is important, especially a QTcF interval longer than 470 ms (a measure of heart rhythm). One high reading may be allowed if the average of three tests is below 470 ms.
  • Having a left‑ventricular ejection fraction (a measure of heart pumping strength) below the normal limit if receiving PLD (a specific study drug).
  • Having active cancer spread to the brain or spinal fluid (known as CNS metastases or carcinomatous meningitis), unless it was treated, stable for at least 4 weeks, and no steroids were needed for at least 7 days.
  • Having another cancer that is getting worse or needs treatment now, or having had another cancer within the past 3 years, except for cured skin cancers, superficial bladder cancer, early‑stage cervical cancer, or other very slow‑growing cancers that have been disease‑free for more than a year.
  • Having lab test results that fall outside the safe ranges defined in the study protocol.
  • Having any other serious medical illness that is not well controlled.
  • Having had a serious stomach or intestinal blockage, or recent (within 3 months) evidence of blockage on imaging, that required hospitalization.
  • Needing frequent removal of fluid from the abdomen (ascites) more often than every 4 weeks, or having a permanent tube in the abdomen, unless the doctor decides it is manageable.
  • Having an ongoing intestinal or pelvic fistula (an abnormal connection) that still needs treatment.
  • Needing feeding through a tube into the gut (enteral) or directly into a vein (parenteral) for nutrition.
  • Having a condition that prevents proper absorption of oral medicines, such as certain surgeries or malabsorption syndromes.
  • Having an active stomach or duodenal ulcer seen on endoscopy.
  • Having serious stomach or intestinal bleeding (vomiting blood, blood in stool, or black tarry stool) within the past 3 months.
  • Having taken any chemotherapy, biological therapy, or targeted therapy within the last 5 half‑lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Having had major surgery within the last 28 days before the first dose of study treatment.
  • Receiving radiation therapy within 14 days before the first dose of study treatment, unless any side effects from radiation have improved to mild (grade 1) or less.
  • Currently taking another experimental (investigational) drug, or having taken one within the last 5 half‑lives or 28 days (whichever is shorter) before the first dose.
  • Using any medication that is prohibited by the study protocol.
  • If assigned to receive INCB123667: currently using, or having used within the last 5 half‑lives or 28 days, a strong CYP3A4/CYP3A5 inhibitor or inducer (drugs that markedly affect how other medicines are processed).
  • If assigned to receive PLD: having previously been diagnosed with non‑infectious interstitial lung disease (ILD) or non‑infectious pneumonitis (lung inflammation not caused by infection).
  • Having a known allergy or severe reaction to any part of the study drugs or their formulation.
  • Being pregnant, breastfeeding, or planning to become pregnant from the time of screening until 180 days after the last dose of INCB123667, paclitaxel, gemcitabine, or topotecan, and 240 days after the last dose of PLD. In Japan, breastfeeding must stop at least 90 days before treatment and remain stopped for 90 days after the last dose.
  • Having a known active hepatitis B infection with detectable HBV DNA (the virus’s genetic material). If the virus level is 500 IU/mL or higher, or if not on antiviral treatment for at least 14 days before the first dose, the patient cannot join.
  • Having a known active hepatitis C infection with detectable HCV RNA (viral genetic material). Patients who have completed treatment and are HCV‑RNA negative are allowed.
  • Having a known HIV infection with any of the following: CD4+ T‑cell count (a measure of immune health) below 350 cells/µL, detectable HIV RNA (virus present in blood), or being on antiretroviral therapy (ART) that contains strong CYP3A4/CYP3A5 inhibitors or inducers. Switching to weaker/moderate drugs is allowed if taken for at least 28 days before treatment.
  • Having any other infection that needed systemic antibiotics, antifungals, or antivirals within 1 week before the first dose.
  • Having a history of blood clots (thromboembolism) while on optimal blood‑thinner therapy, or having had a clot and being on therapeutic anticoagulation for less than 2 weeks before the first dose.
  • Having side effects from previous therapy or complications from prior surgery that have not improved to mild (grade 1) or less, except for mild hair loss or skin color changes (grade 2).
  • Having previously been treated with any CDK2 inhibitor (a type of targeted cancer drug).
  • Having unresolved nerve problems (neuropathy) that are worse than mild (grade 1) if assigned to receive paclitaxel only.
  • Having a known allergy to peanuts or soy if assigned to receive PLD only.
  • Any condition that, in the doctor’s judgment, would prevent full participation in the study, pose a significant risk, or make it hard to interpret the study results.
  • Being part of a vulnerable population prohibited by French law (adults under legal protection, unable to consent, or not covered by social security).
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Investigated drugs

  • INCB123667

    is an experimental oral tablet being tested in this study. It is taken by mouth and is meant to see if it can slow down the growth of ovarian cancer that does not respond to platinum‑based treatments. This drug is the main new medicine being evaluated for its ability to improve how long patients live without the cancer getting worse.

  • 8‑ETHOXY‑N‑((3R,4S)‑3‑METHYL‑1‑(METHYLSULFONYL)PIPERIDIN‑4‑YL)‑7‑(1H‑PYRAZOL‑4‑YL)‑[1,2,4]TRIAZOLO[1,5‑A]PYRIDIN‑2‑AMINE

    is another experimental oral tablet used in the trial. Like the first test drug, it is swallowed and is being studied to find out whether it can help control platinum‑resistant ovarian cancer that has high levels of a protein called cyclin E1.

  • Paclitaxel

    is a chemotherapy medicine that is given through an IV infusion. In this trial it serves as one of the standard chemotherapy options that doctors may choose for patients. It works by stopping cancer cells from dividing, and the study will compare its effect to the new experimental drug.

  • Topotecan hydrochloride

    is a chemotherapy drug given by IV injection. It is another option that investigators can select as a standard treatment for participants. It interferes with the DNA of cancer cells, trying to stop them from growing.

  • Gemcitabine hydrochloride

    is an IV chemotherapy medication. It is included as a possible standard chemotherapy choice in the study. It works by inserting itself into the cancer cell’s DNA, which can prevent the cells from multiplying.

  • Caelyx pegylated liposomal doxorubicin

    (containing doxorubicin hydrochloride) is a specially formulated version of the chemotherapy drug doxorubicin that is given as an IV infusion. The liposomal (tiny bubble) form helps the drug stay in the bloodstream longer and may reduce some side effects. It is one of the standard chemotherapy options that doctors may pick for patients in the trial.

What is already known about the treatment

  • INCB123667

    This drug is taken as an oral tablet, 100 mg taken by mouth. It is still investigational and is being studied in clinical trials for safety and effectiveness. The main use being explored is for treating ovarian cancer that does not respond to platinum chemotherapy. It works by blocking a protein that helps cancer cells grow, classifying it as a targeted kinase inhibitor.

  • 8‑Ethoxy‑N‑((3R,4S)‑3‑Methyl‑1‑(Methylsulfonyl)piperidin‑4‑yl)‑7‑(1H‑pyrazol‑4‑yl)‑[1,2,4]triazolo[1,5‑a]pyridin‑2‑amine

    This experimental agent is also given as an oral tablet, 100 mg taken by mouth. It is currently in early‑phase clinical testing and not yet approved for any disease. Researchers are evaluating it for ovarian cancer that is resistant to standard treatments. The molecule blocks a key enzyme that signals cancer cells to multiply, placing it in the class of small‑molecule enzyme inhibitors.

  • Paclitaxel

    Paclitaxel is given by intravenous infusion, where the drug is slowly delivered into a vein. It is an approved chemotherapy drug used for many cancers, including ovarian cancer. The drug works by stabilizing tiny structures inside cells called microtubules, preventing cancer cells from dividing. It belongs to the taxane class of antineoplastic agents.

  • Topotecan Hydrochloride

    Topotecan is administered intravenously, directly into a vein as a short infusion. It is an approved chemotherapy for ovarian and other solid tumors. The medication blocks an enzyme called topoisomerase I, which is needed for DNA replication in cancer cells. It is classified as a topoisomerase inhibitor.

  • Gemcitabine Hydrochloride

    Gemcitabine is given by intravenous infusion into a vein over several minutes. It is an approved treatment for ovarian cancer and several other solid tumors. The drug mimics a building block of DNA, causing the cancer cell’s DNA to stop growing and leading to cell death. It is a nucleoside analog chemotherapy agent.

  • Doxorubicin Hydrochloride (Liposomal)

    This formulation of doxorubicin is delivered as an intravenous solution for infusion. It is an approved chemotherapy used for many cancers, including ovarian cancer, and the liposomal version helps reduce side effects. Doxorubicin works by slipping into DNA and stopping the cancer cell’s ability to copy its genetic material. It belongs to the anthracycline class of antitumor antibiotics.

Investigated diseases

Ovarian cancer - Ovarian cancer is a type of cancer that begins in the cells of the ovary, the organ that produces eggs. It often grows without causing noticeable symptoms at first, allowing the tumor to increase in size. Over time the cancer cells can break away and spread to nearby pelvic organs, the lining of the abdomen, and eventually to distant parts of the body. The disease may progress from a small localized tumor to involvement of multiple areas, affecting the function of nearby organs. As the tumor expands, it can lead to the accumulation of fluid in the abdomen and cause discomfort. The pattern of spread can vary, but the typical course involves gradual growth and dissemination.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522748-42-00Protocol codeINCB123667-305Estimated enrolment466 patientsSponsorIncyte Corp.

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