Genitourinary & Gynecologic Cancer

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

Incyte Study ID:
INCB123667-203
CT.gov ID:
NCT07023627
Eudra ID:
N/A
EU CT Number:
2025-521513-14-00
Sponsor:
Incyte Corporation
Collaborator:
GOG Foundation
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • Genitourinary & Gynecologic Cancer
    • PRODUCT
  • Drug: INCB123667
    • COLLABORATORS
    GOG Foundation
    DATE
    Aug 2025 - Oct 2027
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female only
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    HOBART HOSPITAL-ROYAL HOBART HOSPITAL
    HOBART, TAS, Australia, 07000
    Status
    Not yet recruiting
    Name
    CANCER RESEARCH SA (CRSA)
    ADELAIDE, Australia, 05000
    Status
    Not yet recruiting
    Name
    BLACKTOWN CANCER & HAEMATOLOGY CENTRE-BLACKTOWN HOSPITAL
    BLACKTOWN, NSW, Australia, 02148
    Status
    Not yet recruiting
    Name
    CONCORD GENERAL REPATRIATION HOSPITAL
    CONCORD, NSW, Australia, 02139
    Status
    Not yet recruiting
    Name
    SOUTHERN ONCOLOGY CLINICAL RESEARCH UNIT
    SOUTH AUSTRALIA, Australia, 05042
    Status
    Not yet recruiting
    Name
    CLINIQUES UNIVERSITAIRES ST LUC UCL
    BRUSSELS, Belgium, B-1200
    Status
    Not yet recruiting
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
    • Have platinum-resistant disease:

    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.
    Requirements information
    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.
    • Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
    • 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.

    Protocol Summary

    Incyte Study ID:
    INCB123667-203
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCB123667
    • Enrollment:
    160
    Primary Outcome
    Open

    Objective Response by IRC

    Timeframe: Up to 2 years

    Secondary Outcome
    Open

    Duration of Response (DOR) by IRC

    Timeframe: Up to 2 years

    Progression-Free Survival (PFS) by IRC

    Timeframe: Up to 2 years

    Overall Survival (OS)

    Timeframe: Up to 2 years

    Objective Response by Investigator

    Timeframe: Up to 2 years

    DOR by investigator

    Timeframe: Up to 2 years

    PFS by Investigator

    Timeframe: Up to 2 years

    Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: Up to 2 years and 30 days

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

    Timeframe: Up to 2 years and 30 days