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Набира участници Фаза 3 NCT07213804

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Кой може да участва
Inclusion Criteria: Part A and B: * Have histologically confirmed high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer. * Have confirmed availability of tumor tissue block or slides * Have radiographic progression on or after most recent line of systemic anticancer therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Have measurable disease per RECIST v1.1 Part A: * Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy. * Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine. * Have received prior bevacizumab treatment, unless documented contraindication or intolerance. * Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance. Part B: * Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy * Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy * Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment. Exclusion Criteria: Part A and B: \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: \- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy. Part B: \- Have clinically significant proteinuria
Места на провеждане 24
Австралия (1)
Ballarat Health Services
Ballarat Central
NOT_YET_RECRUITING
Белгия (1)
Institut Jules Bordet
Anderlecht
NOT_YET_RECRUITING
Бразилия (1)
CPAM - Centro de Pesquisas da Amazônia
Belém
NOT_YET_RECRUITING
Канада (1)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary
NOT_YET_RECRUITING
Китай (1)
Peking University First Hospital
Beijing
NOT_YET_RECRUITING
Чехия (1)
Fakultní Nemocnice Brno
Brno
NOT_YET_RECRUITING
Дания (1)
Rigshospitalet
Copenhagen
NOT_YET_RECRUITING
Франция (1)
Institut de Cancérologie de l'Ouest
Angers
NOT_YET_RECRUITING
Гърция (1)
Alexandra Hospital
Athens
NOT_YET_RECRUITING
Унгария (1)
Országos Onkológiai Intézet
Budapest
NOT_YET_RECRUITING
Ireland (1)
Cork University Hospital
Cork
NOT_YET_RECRUITING
Италия (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna
NOT_YET_RECRUITING
Япония (1)
Hyogo Cancer Center
Akashi
NOT_YET_RECRUITING
Mexico (1)
Scientia Investigacion Clinica S.C.
Chihuahua City
NOT_YET_RECRUITING
Нидерландия (1)
University Medical Center Groningen
Groningen
NOT_YET_RECRUITING
Норвегия (1)
Oslo universitetssykehus, Radiumhospitalet
Oslo
NOT_YET_RECRUITING
Полша (1)
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok
NOT_YET_RECRUITING
Румъния (1)
SC Memorial Healthcare International SRL
Bucharest
NOT_YET_RECRUITING
Южна Корея (1)
Keimyung University Dongsan Hospital
Daegu
NOT_YET_RECRUITING
Испания (1)
Hospital Universitari Dexeus
Barcelona
NOT_YET_RECRUITING
Швейцария (1)
Kantonsspital Baden
Baden
NOT_YET_RECRUITING
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist
NOT_YET_RECRUITING
Великобритания (1)
Royal United Hospitals NHS Foundation Trust
Bath
NOT_YET_RECRUITING
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.10.2025
Крайна дата
01.08.2031
Регистрационен номер
NCT07213804
Източник
anzctr
Запитване за медицински туризъм

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