Phase II Study of INCB123667 in Platinum-Resistant Ovarian Cancer with Cyclin E1 Overexpression
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Bellinzona, Ginevra, Losanna, Altro
(BASEC)
Graubünden
(BASEC)
Sponsor
Incyte Corporation Incyte Biosciences International Sàrl
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Aaron Packman
+1 302 498 6710
apackman@clutterincyte.comIncyte Corporation 1801 Augustine Cut-Off 19803 Wilmington, DE United States
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
21.04.2026
(BASEC)
ID di studio ICTRP
NCT07023627 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (BASEC)
Titolo accademico
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1) (ICTRP)
Titolo pubblico
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (ICTRP)
Malattie studiate
Ovarian Cancer (ICTRP)
Intervento studiato
Drug: INCB123667 (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
ENGOT Foundation;GOG Foundation (ICTRP)
Contatti aggiuntivi
Incyte Medical MonitorIncyte Corporation Call Center (US), medinfo@incyte.com, 1.855.463.3463, Incyte Corporation (ICTRP)
ID secondari
GOG-3129, 2025-521513-14-00, OV94, INCB123667-203 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07023627 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile