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Recruiting Phase 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

Phase 3 – large-scale trial before approval
Conditions: Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 24
Australia (1)
Ballarat Health Services
Ballarat Central
NOT_YET_RECRUITING
Belgium (1)
Institut Jules Bordet
Anderlecht
NOT_YET_RECRUITING
Brazil (1)
CPAM - Centro de Pesquisas da Amazônia
Belém
NOT_YET_RECRUITING
Canada (1)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary
NOT_YET_RECRUITING
China (1)
Peking University First Hospital
Beijing
NOT_YET_RECRUITING
Czech Republic (1)
Fakultní Nemocnice Brno
Brno
NOT_YET_RECRUITING
Denmark (1)
Rigshospitalet
Copenhagen
NOT_YET_RECRUITING
France (1)
Institut de Cancérologie de l'Ouest
Angers
NOT_YET_RECRUITING
Greece (1)
Alexandra Hospital
Athens
NOT_YET_RECRUITING
Hungary (1)
Országos Onkológiai Intézet
Budapest
NOT_YET_RECRUITING
Ireland (1)
Cork University Hospital
Cork
NOT_YET_RECRUITING
Italy (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna
NOT_YET_RECRUITING
Japan (1)
Hyogo Cancer Center
Akashi
NOT_YET_RECRUITING
Mexico (1)
Scientia Investigacion Clinica S.C.
Chihuahua City
NOT_YET_RECRUITING
Netherlands (1)
University Medical Center Groningen
Groningen
NOT_YET_RECRUITING
Norway (1)
Oslo universitetssykehus, Radiumhospitalet
Oslo
NOT_YET_RECRUITING
Poland (1)
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok
NOT_YET_RECRUITING
Romania (1)
SC Memorial Healthcare International SRL
Bucharest
NOT_YET_RECRUITING
South Korea (1)
Keimyung University Dongsan Hospital
Daegu
NOT_YET_RECRUITING
Spain (1)
Hospital Universitari Dexeus
Barcelona
NOT_YET_RECRUITING
Switzerland (1)
Kantonsspital Baden
Baden
NOT_YET_RECRUITING
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist
NOT_YET_RECRUITING
United Kingdom (1)
Royal United Hospitals NHS Foundation Trust
Bath
NOT_YET_RECRUITING
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.10.2025
Completion date
01.08.2031
Registry ID
NCT07213804
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.