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A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
1080 patients around the world
Available in United States, Mexico
Eli Lilly and Company
8Research sites
1080Patients around the world
This study is for people with
Ovarian cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Part A and B:Have histologically confirmed high-grade serous 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.
- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.Have clinically significant proteinuria.
Sites
CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos
Health Pharma Professional Research
COI Centro Oncológico Internacional S.A.P.I
Centro de Atención e Investigación Clínica en Oncología - Mérida
Unidad Médica Onco-hematológica
PanAmerican Clinical Research - Querétaro
Hospital Ángeles Tijuana
Centro Oncológico Estatal ISSEMyM
StudyFRAmework-01
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Ovarian cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07213804
