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

Official title

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

Overview

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

Interventions

• Drug INCB123667
  Administered orally twice daily (BID).

Primary outcome measures

• Objective Response by IRC [Time frame: Up to 2 years]

Secondary outcome measures (8)

• Duration of Response (DOR) by IRC [Time frame: Up to 2 years]
• Progression-Free Survival (PFS) by IRC [Time frame: Up to 2 years]
• Overall Survival (OS) [Time frame: Up to 2 years]
• Objective Response by Investigator [Time frame: Up to 2 years]
• DOR by investigator [Time frame: Up to 2 years]
• PFS by Investigator [Time frame: Up to 2 years]
• Treatment Emergent Adverse Events (TEAE'S) [Time frame: Up to 2 years and 30 days]
• TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time frame: Up to 2 years and 30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 38 centers

• Usa Health Mitchell Cancer Institute — Mobile
• University of California, Los Angeles Medical Center — Los Angeles
• Scripps Healthscripps Mercy Hospital Prebys Cancer Center — San Diego
• Medstar Georgetown University Hospital — Washington D.C.
• Florida Cancer Specialists & Research Institute — Fort Myers
• Sylvester Comprehensive Cancer Center — Miami
• Mount Sinai Comprehensive Cancer Center — Miami Beach
• Florida Cancer Specialists & Research Institute — West Palm Beach
• … and 30 more centers

Spain · 10 centers

• Hospital Universitario Vall D'Hebron — Barcelona
• Hospital Clinic de Barcelona — Barcelona
• Instituto Catalan de Oncologia - Hospital Duran I Reynals — Barcelona
• Hospital Universitario Reina Sofia — Córdoba
• Institut Catala D'Oncologia Girona — Girona
• Clinica Universidad de Navarra - Sede Madrid — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Virgen de La Arrixaca — Murcia
• … and 2 more centers

Japan · 7 centers

• Hyogo Cancer Center — Akashi-shi
• Saitama Medical University International Medical Center — Hidaka-shi
• The Cancer Institute Hospital of Jfcr — Kōtoku
• Kurume University Hospital — Kurume
• Shikoku Cancer Center — Matsuyama
• Hokkaido University Hospital — Sapporo
• Shizuoka Cancer Center — Sunto-gun

Australia · 5 centers

• Blacktown Cancer & Haematology Centre-Blacktown Hospital — Blacktown
• Concord General Repatriation Hospital — Concord
• Burnside War Memorial Hospital - the Brian Fricker Oncology Centre — Adelaide
• Hobart Hospital-Royal Hobart Hospital — Hobart
• Cancer Research Sa (Crsa) — Adelaide

Belgium · 5 centers

• Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet — Brussels
• Cliniques Universitaires St Luc Ucl — Brussels
• Az Groeninge — Kortrijk
• Universitair Ziekenhuis Leuven — Leuven
• Chu Liege — Liège

Switzerland · 4 centers

• Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona — Bellinzona
• Kantonsspital Graubunden — Chur
• Geneva University Hospitals-Hug — Geneva
• Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batim — Lausanne

United Kingdom · 4 centers

• Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust — London
• Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust — London
• Hammersmith Hospital - Imperial College Healthcare Nhs Trust — London
• The Christie Nhs Foundation Trust — Manchester Greater

Puerto Rico · 1 center

• Panoncology Trials — San Juan

Identifiers

NCT: NCT07023627 · INCB123667-203 · GOG-3129 · 2025-521513-14-00 · OV94

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗