INCB123667 for Platinum-Resistant Ovarian Cancer

(MAESTRA 1 Trial)

Recruiting at 83 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must be taking: Bevacizumab, Mirvetuximab soravtansine

Disqualifiers: Endometrioid, Cardiac disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INCB123667 for individuals with ovarian cancer that doesn't respond well to platinum-based therapies. Researchers aim to determine the safety and effectiveness of this treatment, particularly for those whose tumors exhibit high levels of the protein Cyclin E1. Participants should have ovarian cancer resistant to platinum treatments after 1 to 4 rounds of therapy and must agree to a biopsy before starting the trial. The trial excludes individuals with certain cancer types or active heart or brain issues. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that INCB123667 is likely to be safe for humans?

Studies have shown that INCB123667, a drug tested for treating platinum-resistant ovarian cancer, is generally safe. Patients in past studies handled it well without serious side effects. Research indicates that INCB123667 has demonstrated encouraging safety results in patients with this type of cancer.

In an earlier study, patients did not report major problems while taking the drug. This finding reassures those considering joining the trial, suggesting the drug may be safe at the tested doses. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about INCB123667 for treating platinum-resistant ovarian cancer because it takes a new approach by targeting tumor cyclin E1 expression levels. This focus is different from the standard treatments like platinum-based chemotherapy, which often become ineffective when resistance develops. By honing in on this specific protein, INCB123667 has the potential to overcome resistance issues and provide a more tailored and effective response for patients. This targeted mechanism could offer renewed hope for those who have exhausted other options.

What evidence suggests that INCB123667 might be an effective treatment for platinum-resistant ovarian cancer?

Research has shown that INCB123667, a new drug, offers promising results for treating ovarian cancer unresponsive to standard treatments. Earlier studies found this drug to be safe and demonstrated early signs of efficacy. Specifically, one study reported that 31.3% of patients responded to the treatment, with some experiencing complete tumor disappearance. This trial will administer INCB123667 to participants in different cohorts based on their tumor cyclin E1 expression levels. This approach suggests that INCB123667 could benefit patients whose cancer hasn't improved with other treatments. Overall, the treatment appears hopeful for those facing this challenging condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based treatments. They must have had 1-4 prior systemic therapies and be eligible for single-agent therapy next. Participants need available tumor tissue for study and should have used bevacizumab unless contraindicated.

Inclusion Criteria

My cancer did not respond well to platinum-based treatment.

I have been diagnosed with a specific type of advanced ovarian, fallopian tube, or peritoneal cancer.

I've had 1-4 treatments after my cancer diagnosis and now need a single-drug treatment.

Exclusion Criteria

My ovarian cancer is of a specific type (endometrioid, clear cell, mucinous, sarcomatous, or low-grade).

I have active brain metastases or carcinomatous meningitis.

I have another cancer that is getting worse or needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

INCB123667 is administered to participants based on their tumor cyclin E1 expression levels

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years and 30 days

What Are the Treatments Tested in This Trial?

Interventions

• INCB123667

Trial Overview The trial is testing the safety and effectiveness of a new drug called INCB123667 in participants with platinum-resistant ovarian cancer that overexpresses Cyclin E1. It aims to find out if this drug can help where standard treatments haven't worked well.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Group II: Cohort 2 Experimental Treatment 1 Intervention

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Group III: Cohort 1 Experimental Treatment 1 Intervention

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

ENGOT Foundation

Collaborator

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5514

Safety and preliminary efficacy from a phase 1 study of ... In an ongoing phase 1 study, the potent and selective CDK2 inhibitor, INCB123667, has shown acceptable safety and preliminary efficacy in patients (pts) with ...

2. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incytes-cdk2-inhibitor-incb123667-shows-promising-evidence/

Incyte's CDK2 Inhibitor INCB123667 Shows Promising ... The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a ...

3. targetedonc.com targetedonc.com/view/novel-cdk2-inhibitor-incb123667-shows-promise-in-ovarian-cancer

Novel CDK2 Inhibitor INCB123667 Shows Promise in ... The CDK2 inhibitor INCB123667 showed positive efficacy and safety signals in platinum-resistant/refractory ovarian cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07214779

NCT07214779 | Study to Evaluate INCB123667 Versus ... The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with ...

5. incytemi.com incytemi.com/document/Poster/ASCO%202025%20-%20INCB123667%20(CDK2%20inhibitor)%20in%20Ovarian%20Cancer%20(oral%20presentation).pdf

ASCO 2025 - INCB123667 (CDK2 inhibitor) in Ovarian ... ○ In patients with recurrent platinum-resistant or refractory ovarian cancer, single agent INCB123667 at the dose of 100 mg daily achieved.