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NCT Number: NCT07023627

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

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Blacktown Cancer & Haematology Centre-Blacktown Hospital, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Have platinum-resistant disease:
  • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
  • Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
  • Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.
  • Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
  • Must have received bevacizumab unless there was a contraindication for its use.
  • If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

Exclusion criteria

  • Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
  • Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
  • The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
  • Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Known additional malignancy that is progressing or requires active treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Treatment and study plan

INCB123667

Drug

Administered orally twice daily (BID).

Primary outcomes

  1. Objective Response by IRC

    Time frame: Up to 2 years

    Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary outcomes

  1. Duration of Response (DOR) by IRC

    Time frame: Up to 2 years

    Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

  2. Progression-Free Survival (PFS) by IRC

    Time frame: Up to 2 years

    Defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: Up to 2 years

    Defined as the time from the date of first dose of study drug until death due to any cause.

  4. Objective Response by Investigator

    Time frame: Up to 2 years

    Defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.

  5. DOR by investigator

    Time frame: Up to 2 years

    Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

  6. PFS by Investigator

    Time frame: Up to 2 years

    Defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

  7. Treatment Emergent Adverse Events (TEAE'S)

    Time frame: Up to 2 years and 30 days

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.

  8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment

    Time frame: Up to 2 years and 30 days

    TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Collaborators

  • ENGOT Foundation
  • GOG Foundation

Registry information

Official study title

A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

Acronym: MAESTRA 1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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