Phase II Study of INCB123667 in Platinum-Resistant Ovarian Cancer with Cyclin E1 Overexpression
Zusammenfassung der Studie
This study investigates a new treatment, INCB123667, in participants with platinum-resistant ovarian cancer whose tumors exhibit high levels of a protein called Cyclin E1. Approximately 160 participants will be enrolled based on the Cyclin E1 expression of their tumors, determined by a central immunohistochemistry (IHC) assay, into 1 of 3 cohorts. Before enrollment, all participants must provide biopsy tissue samples from before treatment (either freshly taken or archived biopsy samples) during the screening process. The degree of Cyclin E1 expression will be determined from these samples, and participants will be assigned to their cohort. The main study consists of 3 different sections: a screening phase of up to 28 days, a treatment period lasting as long as participants benefit from the treatment and do not meet criteria for treatment discontinuation, and a 30-day follow-up period. It is estimated that an individual will participate in the study for about 24 months. The investigational drug INCB123667 is new and not yet approved for marketing. The risks and potential side effects of taking INCB123667 are not fully known and may vary depending on the condition for which the patient is being treated. INCB123667 may offer a promising option for the treatment of advanced cancers by targeting cyclin-dependent kinase 2 (CDK2), a protein involved in cell division that is often overactive in certain tumors, such as ovarian cancer.
(BASEC)
Untersuchte Intervention
This study investigates a new treatment, INCB123667, in participants with platinum-resistant ovarian cancer whose tumors exhibit high levels of a protein called Cyclin E1. Approximately 160 participants will be enrolled based on the Cyclin E1 expression of their tumors, determined by a central immunohistochemistry (IHC) assay, into 1 of 3 cohorts. Before enrollment, all participants must provide biopsy tissue samples from before treatment (either freshly taken or archived biopsy samples) during the screening process. The degree of Cyclin E1 expression will be determined from these samples, and participants will be assigned to their cohort. The main study consists of 3 different sections: a screening phase of up to 28 days, a treatment period lasting as long as participants benefit from the treatment and do not meet criteria for treatment discontinuation, and a 30-day follow-up period. It is estimated that an individual will participate in the study for about 24 months. The investigational drug INCB123667 is new and not yet approved for marketing. The risks and potential side effects of taking INCB123667 are not fully known and may vary depending on the condition for which the patient is being treated. INCB123667 may offer a promising option for the treatment of advanced cancers by targeting cyclin-dependent kinase 2 (CDK2), a protein involved in cell division that is often overactive in certain tumors, such as ovarian cancer. Compounds that target proteins involved in cell division in a similar manner have shown clinical benefit in difficult-to-treat cancers. However, it cannot be guaranteed that participants will derive benefit from participating in this study. The information gained from the study may help develop better treatments for platinum-resistant ovarian cancer. The study is being conducted to understand how well INCB123667 works, how safe it is, and how well it is tolerated by individuals with platinum-resistant ovarian cancer whose tumors have high Cyclin E1 levels. Participants will take INCB123667 in continuous 28-day cycles twice daily as long as they derive benefit and do not meet criteria for treatment discontinuation. Participants will undergo physical examinations, regular blood and urine tests, EKG recordings, and vital sign measurements. Additionally, their cancer will be monitored using imaging techniques.
(BASEC)
Untersuchte Krankheit(en)
Platinum-resistant, high-grade, serious epithelial carcinoma of the ovaries or fallopian tubes, or primary peritoneal carcinoma with increased production of Cyclin E1 (Cyclin E1 overexpression)
(BASEC)
- platinum-resistant, high-grade, serious epithelial carcinoma of the ovaries or fallopian tubes, or primary peritoneal carcinoma with increased production of Cyclin E1 (Cyclin E1 overexpression) - good physical performance status (ECOG performance status of 0 or 1) - documented disease progression during or after the last cancer therapy (BASEC)
Ausschlusskriterien
- tumors with a specific nature: attributable to endometrial tissue (endometriosis), clear cell, mucinous, or sarcomatoid, mixed tumors - a platinum-refractory primary disease - clinically significant (significant) or uncontrolled heart disease within 6 months prior to the first dose of the investigational drug (BASEC)
Studienstandort
Bellinzona, Genf, Lausanne, Andere
(BASEC)
Graubünden
(BASEC)
Sponsor
Incyte Corporation Incyte Biosciences International Sàrl
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Aaron Packman
+1 302 498 6710
apackman@clutterincyte.comIncyte Corporation 1801 Augustine Cut-Off 19803 Wilmington, DE United States
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
21.04.2026
(BASEC)
ICTRP Studien-ID
NCT07023627 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (BASEC)
Wissenschaftlicher Titel
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1) (ICTRP)
Öffentlicher Titel
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (ICTRP)
Untersuchte Krankheit(en)
Ovarian Cancer (ICTRP)
Untersuchte Intervention
Drug: INCB123667 (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 FRa, 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 FRa 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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Objective Response by IRC (ICTRP)
Duration of Response (DOR) by IRC;Progression-Free Survival (PFS) by IRC;Overall Survival (OS);Objective Response by Investigator;DOR by investigator;PFS by Investigator;Treatment Emergent Adverse Events (TEAE'S);TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
ENGOT Foundation;GOG Foundation (ICTRP)
Weitere Kontakte
Incyte Medical MonitorIncyte Corporation Call Center (US), medinfo@incyte.com, 1.855.463.3463, Incyte Corporation (ICTRP)
Sekundäre IDs
GOG-3129, 2025-521513-14-00, OV94, INCB123667-203 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07023627 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar