INCB123667 for Ovarian Cancer

(MAESTRA 2 Trial)

Recruiting at 141 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Disqualifiers: Endometrioid, Cardiac disease, CNS metastases, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

466 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, INCB123667 (an experimental treatment), for individuals with a type of ovarian cancer that does not respond to standard platinum-based chemotherapy. Researchers aim to determine if this new treatment outperforms other chemotherapies selected by doctors. It suits those with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have not succeeded with other treatments. Participants should not have certain specific cancer types or significant recent heart issues. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants access to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

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 this trial's treatments are likely to be safe?

Research has shown that INCB123667 was safe in early studies. Patients with ovarian cancer tolerated the treatment well at the administered doses, and any side effects were manageable. This suggests that INCB123667 might be safe, but further information is needed for confirmation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

INCB123667 is unique because it targets ovarian cancer through a new mechanism of action. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, INCB123667 is designed to selectively target cancerous cells, potentially reducing side effects. Researchers are excited because this approach could offer a more effective and tolerable treatment option for patients. Meanwhile, in Treatment Group B, doctors use their choice of chemotherapy, which may provide insights into how INCB123667 compares with existing standard treatments.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research shows that INCB123667, which participants in this trial may receive, may help treat ovarian cancer unresponsive to platinum-based treatments. Earlier studies found this drug, which inhibits proteins that aid cancer cell growth, to be safe and effective. Specifically, one study found that 31.3% of participants responded positively, with some experiencing a temporary complete disappearance of their cancer. This suggests that INCB123667 could work well for individuals whose cancer has high levels of cyclin E1, a protein linked to cancer growth. While more research is needed, these findings offer hope for its potential use. ^{1 2 4 5 6}

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 who have received 1-4 lines of platinum-based therapy and are now resistant. They must have measurable disease, available tumor tissue for study, and should have had prior treatments including bevacizumab and possibly mirvetuximab soravtansine.

Inclusion Criteria

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

My condition does not improve with platinum-based chemotherapy.

I have completed at least 4 cycles of a platinum-based treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either INCB123667 or investigator's choice of chemotherapy at the protocol-defined dose

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 study compares INCB123667 to a chemotherapy chosen by the investigator in participants with platinum-resistant ovarian cancer that overexpresses Cyclin E1. The goal is to see which treatment works better for this specific condition.

How Is the Trial Designed?

Group I: Treatment Group B (TGB) Experimental Treatment 1 Intervention

Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.

Group II: Treatment Group A (TGA) Experimental Treatment 1 Intervention

INCB123667 at the protocol-defined dose.

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

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

ENGOT Foundation

Collaborator

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 ...

Results: As of Dec 19, 2024, 90 pts with advanced/metastatic platinum-r/r OC received INCB123667: 45 in part 1A (50 mg qd, n=1; 50 mg bid, n=4; ...

2.

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.

3.

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 ...

4.

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 ...

○ Here we report safety and efficacy data of Part 1B. *Mucinous, carcinosarcoma, neuroendocrine and adenocarcinoma-NOS. †Overexpression as ...

5.

clin.larvol.com

clin.larvol.com/trial-detail/NCT05238922

Study of INCB123667 in Subjects With Advanced Solid Tumors

The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants)....Results from the Part 1a dose ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07023627

A Study of INCB123667 in Participants With Platinum- ...

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.